24 results on '"Wormald, R"'
Search Results
2. Principles of clinical trials
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WORMALD, R, primary
- Published
- 2008
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3. Summary: Ethical issues in trials
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WORMALD, R, primary
- Published
- 2008
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4. Geochemistry and Rb-Sr geochronology of the alkaline-peralkaline Narraburra Complex, central southern New South Wales; tectonic significance of Late Devonian granitic magmatism in the Lachlan Fold Belt
- Author
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WORMALD, R. J., primary, PRICE, R. C., additional, and KEMP, A. I. S., additional
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- 2004
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5. Survival and prognosis of surgical head and neck cancer patients aged 80 years and older.
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Sobhi S, Wormald R, Hollitt S, and Flukes S
- Abstract
Introduction: Elderly patients (≥80 years of age) with head and neck cancer (HNC) can prove a management challenge due to concerns regarding their suitability for surgery. This study aims to describe the characteristics and outcomes of elderly patients undergoing HNC surgery., Methods: A retrospective review of elderly patients undergoing HNC surgery was conducted. Demographics, comorbidities, tumor characteristics, surgical procedure type, postoperative complications, and disposition were reviewed. Overall survival (OS) in the elderly cohort was compared against younger patients (<80 years)., Results: A total of 595 patients were included, of whom 86 were aged >80 years (71% male; mean age 84.8, range 80.0-98.8 years). The overall complication rate was 43%. When compared with younger patients ( n = 509), elderly patients had reduced OS (risk ratio: 2.0, 95% CI: 1.3-3.2), higher 90-day mortality (8.1% vs. 2.3%, p = .005), and lower 5-year survival (43.5% vs. 64.1%, p < .001). However, survival was comparable to age-specific life expectancy. There was no difference in OS, 90-day mortality, and 5-year survival when comparing >85 ( n = 33) and 80-85 ( n = 53) age groups., Conclusions: Chronological age alone should not negatively influence decision-making in HNC surgery the elderly. With careful preoperative selection and optimization, surgery can be performed at acceptable risk with good outcomes in elderly patients., Level of Evidence: IV., Competing Interests: The authors declare no conflicts of interest., (© 2023 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals LLC on behalf of The Triological Society.)
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- 2023
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6. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension.
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Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, and Evans JR
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- Argon therapeutic use, Humans, Glaucoma surgery, Glaucoma, Open-Angle drug therapy, Glaucoma, Open-Angle surgery, Ocular Hypertension etiology, Ocular Hypertension surgery, Optic Nerve Diseases etiology, Optic Nerve Diseases surgery, Trabeculectomy adverse effects, Trabeculectomy methods
- Abstract
Background: Open-angle glaucoma (OAG) is an important cause of blindness worldwide. Laser trabeculoplasty, a treatment modality, still does not have a clear position in the treatment sequence., Objectives: To assess the effects of laser trabeculoplasty for treating OAG and ocular hypertension (OHT) when compared to medication, glaucoma surgery or no intervention. We also wished to compare the effectiveness of different laser trabeculoplasty technologies for treating OAG and OHT., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; LILACS, ClinicalTrials.gov and the WHO ICTRP. The date of the search was 28 October 2021. We also contacted researchers in the field., Selection Criteria: We included randomised controlled trials (RCTs) comparing laser trabeculoplasty with no intervention, with medical treatment, or with surgery in people with OAG or OHT. We also included trials comparing different types of laser trabeculoplasty technologies., Data Collection and Analysis: We used standard methods expected by Cochrane. Two authors screened search results and extracted data independently. We considered the following outcomes at 24 months: failure to control intraocular pressure (IOP), failure to stabilise visual field progression, failure to stabilise optic neuropathy progression, adverse effects, quality of life, and costs. We graded the 'certainty' of the evidence using GRADE., Main Results: We included 40 studies (5613 eyes of 4028 people) in this review. The majority of the studies were conducted in Europe and in the USA. Most of the studies were at risk of performance and/or detection bias as they were unmasked. None of the studies were judged as having low risk of bias for all domains. We did not identify any studies of laser trabeculoplasty alone versus no intervention. Laser trabeculoplasty versus medication Fourteen studies compared laser trabeculoplasty with medication in either people with primary OAG (7 studies) or primary or secondary OAG (7 studies); five of the 14 studies also included participants with OHT. Six studies used argon laser trabeculoplasty and eight studies used selective laser trabeculoplasty. There was considerable clinical and methodological diversity in these studies leading to statistical heterogeneity in results for the primary outcome "failure to control IOP" at 24 months. Risk ratios (RRs) ranged from 0.43 in favour of laser trabeculoplasty to 1.87 in favour of medication (5 studies, I
2 = 89%). Studies of argon laser compared with medication were more likely to show a beneficial effect compared with studies of selective laser (test for interaction P = 0.0001) but the argon laser studies were older and the medication comparator group in those studies may have been less effective. We considered this to be low-certainty evidence because the trials were at risk of bias (they were not masked) and there was unexplained heterogeneity. There was evidence from two studies (624 eyes) that argon laser treatment was associated with less failure to stabilise visual field progression compared with medication (7% versus 11%, RR 0.70, 95% CI 0.42 to 1.16) at 24 months and one further large recent study of selective laser also reported a reduced risk of failure at 48 months (17% versus 26%) RR 0.65, 95% CI 0.52 to 0.81, 1178 eyes). We judged this outcome as moderate-certainty evidence, downgrading for risk of bias. There was only very low-certainty evidence on optic neuropathy progression. Adverse effects were more commonly seen in the laser trabeculoplasty group including peripheral anterior synechiae (PAS) associated with argon laser (32% versus 26%, RR 11.74, 95% CI 5.94 to 23.22; 624 eyes; 2 RCTs; low-certainty evidence); 5% of participants treated with laser in three studies of selective laser group had early IOP spikes (moderate-certainty evidence). One UK-based study provided moderate-certainty evidence that laser trabeculoplasty was more cost-effective. Laser trabeculoplasty versus trabeculectomy Three studies compared laser trabeculoplasty with trabeculectomy. All three studies enrolled participants with OAG (primary or secondary) and used argon laser. People receiving laser trabeculoplasty may have a higher risk of uncontrolled IOP at 24 months compared with people receiving trabeculectomy (16% versus 8%, RR 2.12, 95% CI 1.44 to 3.11; 901 eyes; 2 RCTs). We judged this to be low-certainty evidence because of risk of bias (trials were not masked) and there was inconsistency between the two trials (I2 = 68%). There was limited evidence on visual field progression suggesting a higher risk of failure with laser trabeculoplasty. There was no information on optic neuropathy progression, quality of life or costs. PAS formation and IOP spikes were not reported but in one study trabeculectomy was associated with an increased risk of cataract (RR 1.78, 95% CI 1.46 to 2.16) (very low-certainty evidence)., Authors' Conclusions: Laser trabeculoplasty may work better than topical medication in slowing down the progression of open-angle glaucoma (rate of visual field loss) and may be similar to modern eye drops in controlling eye pressure at a lower cost. It is not associated with serious unwanted effects, particularly for the newer types of trabeculoplasty, such as selective laser trabeculoplasty., (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)- Published
- 2022
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7. Prophylactic non-steroidal anti-inflammatory drugs for the prevention of macular oedema after cataract surgery.
- Author
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Lim BX, Lim CH, Lim DK, Evans JR, Bunce C, and Wormald R
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- Administration, Topical, Aged, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Humans, Macular Edema etiology, Randomized Controlled Trials as Topic, Steroids therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Cataract Extraction adverse effects, Macular Edema prevention & control, Postoperative Complications prevention & control
- Abstract
Background: Macular oedema (MO) is the accumulation of extracellular fluid in the central retina (the macula). It may occur after cataract surgery and may give rise to poor visual outcome, with reduced visual acuity and distortion of the central vision. MO is often self-limiting with spontaneous resolution, but a small proportion of people with chronic persistent MO may be difficult to treat. Chronic oedema may lead to the formation of cystic spaces in the retina termed 'cystoid macular oedema' (CMO). Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used in cataract surgery and may reduce the chances of developing MO., Objectives: The aim of this review is to answer the question: is there evidence to support the prophylactic use of topical NSAIDs either in addition to, or instead of, topical steroids postoperatively to reduce the incidence of macular oedema (MO) and associated visual morbidity., Search Methods: We searched a number of electronic databases including CENTRAL, MEDLINE and Embase. Date last searched 2 September 2016., Selection Criteria: We included randomised controlled trials (RCTs) in which adult participants had undergone surgery for age-related cataract. We included participants irrespective of their baseline risk of MO, in particular we included people with diabetes and uveitis. We included trials of preoperative and/or postoperative topical NSAIDs in conjunction with postoperative topical steroids. The comparator was postoperative topical steroids alone. A secondary comparison was preoperative and/or postoperative topical NSAIDs alone versus postoperative topical steroids alone., Data Collection and Analysis: Two review authors independently selected studies for inclusion, assessed risk of bias and extracted data using standard methods expected by Cochrane. We pooled data using a random-effects model. We graded the certainty of the evidence using GRADE and considered the following: risk of bias of included studies, precision of the effect estimate, consistency of effects between studies, directness of the outcome measure and publication bias., Main Results: We identified 34 studies that were conducted in the Americas, Europe, the Eastern Mediterranean region and South-East Asia. Over 5000 people were randomised in these trials. The majority of studies enrolled one eye per participant; a small subset (4 trials) enrolled a proportion of people with bilateral surgery. Twenty-eight studies compared NSAIDs plus steroids with steroids alone. Six studies compared NSAIDs with steroids. A variety of NSAIDs were used, including ketorolac, diclofenac, nepafenac, indomethacin, bromfenac, flurbiprofen and pranopfen. Follow-up ranged from one to 12 months. In general, the studies were poorly reported. We did not judge any of the studies at low risk of bias in all domains. Six studies were funded by industry, seven studies were funded from non-industry sources, and the rest of the studies did not report the source of funding.There was low-certainty evidence that people receiving topical NSAIDs in combination with steroids may have a lower risk of poor vision due to MO at three months after cataract surgery compared with people receiving steroids alone (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.23 to 0.76; eyes = 1360; studies = 5; I
2 = 5%). We judged this to be low-certainty evidence because of risk of bias in the included studies and indirectness, as the extent of visual loss was not always clear. Only one study reported poor vision due to MO at 12 months and we judged this to be very low-certainty evidence as there were only two events. Quality of life was only reported in one of the 34 studies comparing NSAIDs plus steroids versus steroids alone, and it was not fully reported, other than to comment on lack of differences between groups. There was evidence of a reduced risk of MO with NSAIDs at three months after surgery, but we judged this to be low-certainty due to risk of bias and publication bias (RR 0.40, 95% CI 0.32 to 0.49; eyes = 3638; studies = 21). There was inconsistent evidence on central retinal thickness at three months (I2 = 87%). Results ranged from -30.9 µm in favour of NSAIDs plus steroids to 7.44 µm in favour of steroids alone. Similarly, data on best corrected visual acuity (BCVA) were inconsistent, but nine out of 10 trials reporting this outcome found between-group differences in visual acuity of less than 0.1 logMAR.None of the six studies comparing NSAIDs alone with steroids reported on poor vision due to MO at three or 12 months. There was low-certainty evidence that central retinal thickness was lower in the NSAIDs group at three months (mean difference (MD) -22.64 µm, 95% CI -38.86 to -6.43; eyes = 121; studies = 2). Five studies reported on MO and showed a reduced risk with NSAIDs, but we judged this evidence to be of low-certainty (RR 0.27, 95% CI 0.18 to 0.41; eyes = 520). Three studies reported BCVA at three months and the results of these trials were inconsistent, but all three studies found differences of less than 0.1 logMAR between groups.We did not note any major adverse events - the main consistent observation was burning or stinging sensation with the use of NSAIDs., Authors' Conclusions: Using topical NSAIDs may reduce the risk of developing macular oedema after cataract surgery, although it is possible that current estimates as to the size of this reduction are exaggerated. It is unclear the extent to which this reduction has an impact on the visual function and quality of life of patients. There is little evidence to suggest any important effect on vision after surgery. The value of adding topical NSAIDs to steroids, or using them as an alternative to topical steroids, with a view to reducing the risk of poor visual outcome after cataract surgery is therefore uncertain. Future trials should address the remaining clinical uncertainty of whether prophylactic topical NSAIDs are of benefit, particularly with respect to longer-term follow-up (at least to 12 months), and should be large enough to detect reduction in the risk of the outcome of most interest to patients, which is chronic macular oedema leading to visual loss.- Published
- 2016
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8. Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma.
- Author
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Hu K, Gazzard G, Bunce C, and Wormald R
- Subjects
- Humans, Randomized Controlled Trials as Topic, Trabeculectomy methods, Glaucoma, Open-Angle surgery, Phacoemulsification, Trabecular Meshwork surgery, Trabeculectomy instrumentation
- Abstract
Background: Glaucoma is the leading cause of irreversible blindness. Minimally invasive surgical techniques, such as ab interno trabecular bypass surgery, have been introduced to prevent glaucoma progressing., Objectives: The main objective was to assess the results at two years of ab interno trabecular bypass surgery with Trabectome for open angle glaucoma in comparison to conventional medical, laser, or surgical treatment in terms of efficacy and safety. A secondary objective was to examine the effects of Trabectome surgery in people who have concomitant phacoemulsification in comparison to those who do not have concomitant phacoemulsification., Search Methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2016), EMBASE (January 1980 to May 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 12 May 2016., Selection Criteria: We included only randomised controlled trials (RCTs) of ab interno trabecular bypass surgery with Trabectome., Data Collection and Analysis: We planned to have two review authors independently extract data from reports of included studies using a data collection form., Main Results: One randomised controlled trial identified from ClinicalTrials.gov, NCT00901108, met the criteria for inclusion. This study has subsequently been terminated. The ClinicalTrials.gov record indicates that the investigators plan to complete 12 months of follow-up and analysis on 19 participants already recruited into the trial., Authors' Conclusions: There is currently no high-quality evidence for the outcomes of ab interno trabecular bypass surgery with Trabectome for open angle glaucoma. Properly designed RCTs are needed to assess the long-term efficacy and safety of this technique.
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- 2016
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9. 5-Fluorouracil for glaucoma surgery.
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Green E, Wilkins M, Bunce C, and Wormald R
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- Cicatrix prevention & control, Humans, Randomized Controlled Trials as Topic, Wound Healing drug effects, Antimetabolites therapeutic use, Fluorouracil therapeutic use, Glaucoma drug therapy, Glaucoma surgery, Trabeculectomy
- Abstract
Background: Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intraocular pressure. The surgery involves creating a channel through the sclera, through which intraocular fluid can leave the eye. If scar tissue blocks the exit of the surgically created channel, intraocular pressure rises and the operation fails. Antimetabolites such as 5-Fluorouracil (5-FU) are used to inhibit wound healing to prevent the conjunctiva scarring down on to the sclera. This is an update of a Cochrane review first published in 2000, and previously updated in 2009., Objectives: To assess the effects of both intraoperative application and postoperative injections of 5-FU in eyes of people undergoing surgery for glaucoma at one year., Search Methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2013), EMBASE (January 1980 to July 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 25 July 2013. We also searched the reference lists of relevant articles and the Science Citation Index and contacted investigators and experts for details of additional relevant trials., Selection Criteria: We included randomised trials of intraoperative application and postoperative 5-FU injections compared with placebo or no treatment in trabeculectomy for glaucoma., Data Collection and Analysis: Two authors independently assessed trial quality and extracted data. We used standard methodological procedures expected by The Cochrane Collaboration. We contacted trial investigators for missing information. Data were summarised using risk ratio (RR), Peto odds ratio and mean difference, as appropriate.The participants were divided into three separate subgroup populations (high risk of failure, combined surgery and primary trabeculectomy) and the interventions were divided into three subgroups of 5-FU injections (intraoperative, regular dose postoperative and low dose postoperative). The low dose was defined as a total dose less than 19 mg., Main Results: Twelve trials, which randomised 1319 participants, were included in the review. As far as can be determined from the trial reports, the methodological quality of the trials was not high, including a high risk of detection bias in many. Of note, only one study reported low-dose postoperative 5-FU and this paper was at high risk of reporting bias.Not all studies reported population characteristics, of those that did mean age ranged from 61 to 75 years. 83% of participants were white and 40% were male. All studies were a minimum of one year long.A significant reduction in surgical failure in the first year after trabeculectomy was detected in eyes at high risk of failure and those undergoing surgery for the first time receiving regular-dose 5-FU postoperative injections (RR 0.44, 95% confidence interval (CI) 0.29 to 0.68 and 0.21, 0.06 to 0.68, respectively). No surgical failures were detected in studies assessing combined surgery. No difference was detected in the low-dose postoperative 5-FU injection group in patients undergoing primary trabeculectomy (RR 0.93, 95% CI 0.70 to 1.24). Peroperative 5-FU in patients undergoing primary trabeculectomy significantly reduced risk of failure (RR 0.67, 95% CI 0.51 to 0.88). This translates to a number needed to treat for an additional beneficial outcome of 4.1 for the high risk of failure patients, and 5.0 for primary trabeculectomy patients receiving postoperative 5-FU.Intraocular pressure was also reduced in the primary trabeculectomy group receiving intraoperative 5-FU (mean difference (MD) -1.04, 95% CI -1.65 to -0.43) and regular-dose postoperative 5-FU (MD -4.67, 95% CI -6.60 to -2.73). No significant change occurred in the primary trabeculectomy group receiving low-dose postoperative 5-FU (MD -0.50, 95% CI -2.96 to 1.96). Intraocular pressure was particularly reduced in the high risk of failure population receiving regular-dose postoperative 5-FU (MD -16.30, 95% CI -18.63 to -13.97). No difference was detected in the combined surgery population receiving regular-dose postoperative 5-FU (MD -1.02, 95% CI -2.40 to 0.37).Whilst no evidence was found of an increased risk of serious sight-threatening complications, other complications are more common after 5-FU injections. None of the trials reported on the participants' perspective of care.The quality of evidence varied between subgroups and outcomes, most notably the evidence for combined surgery and low-dose postoperative 5-FU was found to be very low using GRADE. The combined surgery postoperative 5-FU subgroup because no surgical failures have been reported and the sample size is small (n = 118), and the low-dose postoperative 5-FU group because of the small sample size (n = 76) and high risk of bias of the only contributing study., Authors' Conclusions: Postoperative injections of 5-FU are now rarely used as part of routine packages of postoperative care but are increasingly used on an ad hoc basis. This presumably reflects an aspect of the treatment that is unacceptable to both patients and doctors. None of the trials reported on the participants' perspective of care, which constitutes a serious omission for an invasive treatment such as this.The small but statistically significant reduction in surgical failures and intraocular pressure at one year in the primary trabeculectomy group and high-risk group must be weighed against the increased risk of complications and patient preference.
- Published
- 2014
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10. Non-penetrating filtration surgery versus trabeculectomy for open-angle glaucoma.
- Author
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Eldaly MA, Bunce C, Elsheikha OZ, and Wormald R
- Subjects
- Aged, Humans, Middle Aged, Randomized Controlled Trials as Topic, Glaucoma, Open-Angle surgery, Sclerostomy methods, Trabeculectomy methods
- Abstract
Background: Glaucoma is the second commonest cause of blindness worldwide. Non-penetrating glaucoma surgeries have been developed as a safer and more acceptable surgical intervention to patients compared to conventional procedures., Objectives: To compare the effectiveness of non-penetrating trabecular surgery compared with conventional trabeculectomy in people with glaucoma., Search Methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to September 2013), EMBASE (January 1980 to September 2013), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to September 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 27 September 2013., Selection Criteria: This review included relevant randomised controlled trials (RCTs) and quasi-RCTs on participants undergoing standard trabeculectomy for open-angle glaucoma compared to non-penetrating surgery, specifically viscocanalostomy or deep sclerectomy, with or without adjunctive measures., Data Collection and Analysis: Two review authors independently reviewed the titles and abstracts of the search results. We obtained full copies of all potentially eligible studies and assessed each one according to the definitions in the 'Criteria for considering studies' section of this review. We used standard methodological procedures expected by The Cochrane Collaboration., Main Results: We included five studies with a total of 311 eyes (247 participants) of which 133 eyes (participants) were quasi-randomised. One hundred and sixty eyes which had trabeculectomy were compared to 151 eyes that had non-penetrating glaucoma surgery (of which 101 eyes had deep sclerectomy and 50 eyes had viscocanalostomy). The confidence interval (CI) for the odds ratio (OR) of success (defined as achieving target eye pressure without eye drops) does not exclude a beneficial effect of either deep sclerectomy or trabeculectomy (OR 0.98, 95% CI 0.51 to 1.88). The odds of success in viscocanalostomy participants was lower than in trabeculectomy participants (OR 0.33, 95% CI 0.13 to 0.81). We did not combine the different types of non-penetrating surgery because there was evidence of a subgroup difference when examining total success. The odds ratio for achieving target eye pressure with or without eye drops was imprecise and was compatible with a beneficial effect of either trabeculectomy or non-penetrating filtration surgery (NPFS) (OR 0.79, 95% CI 0.35 to 1.79). Operative adjuvants were used in both treatment groups; more commonly in the NPFS group compared to the trabeculectomy group but no clear effect of their use could be determined. Although the studies were too small to provide definitive evidence regarding the relative safety of the surgical procedures we noted that there were relatively fewer complications with non-filtering surgery compared to trabeculectomy (17% and 65% respectively). Cataract was more commonly reported in the trabeculectomy studies. None of the five trials used quality of life measure questionnaires. The methodological quality of the studies was not good. Most studies were at high risk of bias in at least one domain and for many, there was lack of certainty due to incomplete reporting. Adequate sequence generation was noted only in one study. Similarly, only two studies avoided detection bias. We detected incomplete outcome data in three of the included studies., Authors' Conclusions: This review provides some limited evidence that control of IOP is better with trabeculectomy than viscocanalostomy. For deep sclerectomy, we cannot draw any useful conclusions. This may reflect surgical difficulties in performing non-penetrating procedures and the need for surgical experience. This review has highlighted the lack of use of quality of life outcomes and the need for higher methodological quality RCTs to address these issues. Since it is unlikely that better IOP control will be offered by NPFS, but that these techniques offer potential gains for patients in terms of quality of life, we feel that such a trial is likely to be of a non-inferiority design with quality of life measures.
- Published
- 2014
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11. Ivermectin for onchocercal eye disease (river blindness).
- Author
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Ejere HO, Schwartz E, Wormald R, and Evans JR
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- Humans, Randomized Controlled Trials as Topic, Vision Disorders parasitology, Anthelmintics therapeutic use, Ivermectin therapeutic use, Onchocerciasis, Ocular drug therapy, Vision Disorders prevention & control
- Abstract
Background: It is believed that ivermectin (a microfilaricide) could prevent blindness due to onchocerciasis. However, when given to everyone in communities where onchocerciasis is common, the effects of ivermectin on lesions affecting the eye are uncertain and data on whether the drug prevents visual loss are unclear., Objectives: The aim of this review was to assess the effectiveness of ivermectin in preventing visual impairment and visual field loss in onchocercal eye disease. The secondary aim was to assess the effects of ivermectin on lesions affecting the eye in onchocerciasis., Search Methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 3), MEDLINE (January 1950 to April 2012), EMBASE (January 1980 to April 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 2 April 2012., Selection Criteria: We included randomised controlled trials with at least one year of follow-up comparing ivermectin with placebo or no treatment. Participants in the trials were people normally resident in endemic onchocercal communities with or without one or more characteristic signs of ocular onchocerciasis., Data Collection and Analysis: Two review authors independently extracted data and assessed trial quality. We contacted study authors for additional information. As trials varied in design and setting, we were unable to perform a meta-analysis., Main Results: The review included four trials: two small studies (n = 398) in which people with onchocercal infection were given one dose of ivermectin or placebo and followed up for one year; and two larger community-based studies (n = 4941) whereby all individuals in selected communities were treated every six or 12 months with ivermectin or placebo, whether or not they were infected, and followed for two to three years. The studies provide evidence that treating people who have onchocerciasis with ivermectin reduces the number of microfilariae in their skin and eye(s) and reduces the number of punctate opacities. There was weaker evidence that ivermectin reduced the risk of chorioretinitis. The studies were too small and of too short a duration to provide evidence for an effect on sclerosing keratitis, iridocyclitis, optic nerve disease or visual loss. One community-based study in communities mesoendemic for the savannah strain of O.volvulus provided evidence that annual mass treatment with ivermectin reduces the risk of new cases of optic nerve disease and visual field loss. The other community-based study of mass biannual treatment of ivermectin in communities affected by the forest strain of O.volvulus demonstrated reductions in microfilarial load, punctate keratitis and iridocyclitis but not sclerosing keratitis, chorioretinitis, optic atrophy or visual impairment. The study was underpowered to estimate the effect of ivermectin on visual impairment and other less frequent clinical signs. The studies included in this review reported some adverse effects, in particular an increased risk of postural hypotension in people treated with ivermectin., Authors' Conclusions: The lack of evidence for prevention of visual impairment and blindness should not be interpreted to mean that ivermectin is not effective, however, clearly this is a key question that remains unanswered. The main evidence for a protective effect of mass treatment with ivermectin on visual field loss and optic nerve disease comes from communities mesoendemic for the savannah strain of O.volvulus. Whether these findings can be applied to communities with different endemicity and affected by the forest strain is unclear. Serious adverse effects were rarely reported. None of the studies, however, were conducted in areas where people are infected with Loa loa (loiasis).
- Published
- 2012
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12. Laser trabeculoplasty for open angle glaucoma.
- Author
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Rolim de Moura C, Paranhos A Jr, and Wormald R
- Subjects
- Adrenergic beta-Antagonists adverse effects, Adrenergic beta-Antagonists therapeutic use, Glaucoma, Open-Angle drug therapy, Humans, Ocular Hypertension drug therapy, Ocular Hypertension surgery, Randomized Controlled Trials as Topic, Trabeculectomy adverse effects, Glaucoma, Open-Angle surgery, Laser Therapy methods, Trabecular Meshwork surgery, Trabeculectomy methods
- Abstract
Background: Open angle glaucoma (OAG) is an important cause of blindness worldwide. Laser trabeculoplasty, a treatment modality, still does not have a clear position in the treatment sequence., Objectives: The objective of this review was to study the effects of laser trabeculoplasty for OAG., Search Strategy: We identified trials from CENTRAL in The Cochrane Library, MEDLINE, EMBASE, LILACS and manual searching. We also contacted researchers in the field., Selection Criteria: We included randomised controlled trials comparing laser trabeculoplasty with no intervention, with medical treatment, or with surgery. We also included trials comparing different technical modalities of laser trabeculoplasty., Data Collection and Analysis: Two authors independently assessed trial quality and extracted the data. We contacted trial investigators for missing information., Main Results: This review included 19 trials involving 2137 participants. Only five trials fulfilled the criteria of good methodological quality. One trial compared laser trabeculoplasty with topical beta-blocker to no intervention in early glaucoma. The risk of glaucoma progression was higher in the control group at six years of follow up (risk ratio (RR) 0.71 95% confidence interval (CI) 0.53 to 0.95). No difference in health-related quality of life was observed between the two groups. Three trials compared laser trabeculoplasty to medication (regimens used before the 1990s) in people with newly diagnosed OAG. The risk of uncontrolled intraocular pressure (IOP) was higher in the medication group compared to the trabeculoplasty group at six months and two years of follow up. Three trials compared laser trabeculoplasty with trabeculectomy. The risk of uncontrolled IOP was significantly higher in the trabeculoplasty group at six months but significant heterogeneity was observed at two years. Diode and selective laser are compared to argon laser trabeculoplasty in three trials and there is some evidence showing a comparable effect in controlling IOP at six months and one year of follow up., Authors' Conclusions: Evidence suggests that, in people with newly diagnosed OAG, the risk of uncontrolled IOP is higher in people treated with medication used before the 1990s when compared to laser trabeculoplasty at two years follow up. Trabeculoplasty is less effective than trabeculectomy in controlling IOP at six months and two years follow up. Different laser technology and protocol modalities were compared to the traditional laser trabeculoplasty and more evidence is necessary to determine if they are equivalent or not. There is no evidence to determine the effectiveness of laser trabeculoplasty compared to contemporary medication (prostaglandin analogues, topical anhydrase inhibitors and alpha2-agonists) and also with contemporary surgical techniques. Also there should be further investigation in to the effectiveness of laser trabeculoplasty in specific racial groups, specific diagnostic groups, such as pseudoexfoliation and pigmentary glaucoma and different stages of OAG. More research is also required determining cost-effectiveness of laser trabeculoplasty in the management of glaucoma.
- Published
- 2007
- Full Text
- View/download PDF
13. Photodynamic therapy for neovascular age-related macular degeneration.
- Author
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Wormald R, Evans J, Smeeth L, and Henshaw K
- Subjects
- Glucose therapeutic use, Humans, Macular Degeneration complications, Randomized Controlled Trials as Topic, Verteporfin, Macular Degeneration drug therapy, Photochemotherapy, Photosensitizing Agents therapeutic use, Porphyrins therapeutic use, Retinal Neovascularization drug therapy
- Abstract
Background: In neovascular age-related macular degeneration (AMD) new vessels grow under the retina distorting vision and leading to scarring. This is exacerbated if the blood vessels leak. Photodynamic therapy (PDT) has been investigated as a way to treat the neovascular membranes without affecting the retina., Objectives: The aim of this review was to examine the effects of PDT in the treatment of neovascular AMD., Search Strategy: We searched CENTRAL (Issue 1, 2007), MEDLINE (1966 to March 2007), EMBASE (1980 to March 2007). We contacted experts in the field and searched the reference lists of relevant studies., Selection Criteria: We included randomised trials of PDT in people with choroidal neovascularisation due to AMD., Data Collection and Analysis: Two authors independently extracted the data. Risk ratios were combined using a fixed-effect model after testing for heterogeneity., Main Results: Three published trials were identified that randomised 1022 participants to verteporfin therapy compared to 5% dextrose in water. The TAP and VIP trials were performed by the same investigators using largely the same clinical centres and funded by manufacturers of verteporfin. Outcome data were available at 12 and 24 months after the first treatment. Participants received on average five treatments over two years. The risk ratio of losing three or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.77 (95% confidence interval 0.69 to 0.87). The risk ratio of losing six or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.62 (95% confidence interval 0.50 to 0.76). The results at 12 months were similar to those at 24 months. The most serious adverse outcome, acute (within seven days of treatment) severe visual acuity decrease, occurs in about one in 50 patients. Some outcomes from the more recent VIM trial could be included in the meta-analysis but have not greatly altered the findings., Authors' Conclusions: Photodynamic therapy in people with choroidal neovascularisation due to AMD is probably effective in preventing visual loss though there is doubt about the size of the effect. Outcomes and potential adverse effects of this treatment should be monitored closely. Further independent trials of verteporfin are required to establish that the effects seen in this study are consistent and to examine important issues not yet addressed, particularly relating to quality of life and cost. However, the advent of new interventions for AMD make this unlikely.
- Published
- 2007
- Full Text
- View/download PDF
14. Screening for prevention of optic nerve damage due to chronic open angle glaucoma.
- Author
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Hatt S, Wormald R, and Burr J
- Subjects
- Humans, Optic Nerve Diseases etiology, Glaucoma, Open-Angle diagnosis, Mass Screening, Optic Nerve Diseases prevention & control
- Abstract
Background: Open angle glaucoma (OAG) is a primary, progressive optic neuropathy; the onset is without symptoms and progression occurs silently until the advanced stages of the disease, when it affects central vision. The blindness caused by OAG is irreversible. It has often been assumed to be a condition that fulfils the criteria for population screening, although this has not been supported by other in-depth non-systematic reviews. The focus of this review was to examine the evidence for the effectiveness of screening for OAG., Objectives: To determine the impact of screening for OAG compared with opportunistic case findings or current referral practices on the prevalence of and the degree of optic nerve damage due to OAG in screened and unscreened populations., Search Strategy: We included any randomised controlled trial (RCT) evaluating population-based screening programmes for OAG with a minimum one year follow up. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (which contains the Cochrane Eyes and Vision Trials Register) (Issue 1, 2006), MEDLINE (1950 to February 2006) and EMBASE (1988 to February 2006). We also searched the National Research Register (Issue 1, 2006) and Zetoc for grey literature (29 June 2006). There were no language or date restrictions in the electronic searches., Selection Criteria: We planned to include RCTs, including cluster RCTs., Data Collection and Analysis: Two review authors independently assessed the study abstracts identified by the electronic searches. We did not find any trials that met the inclusion criteria., Main Results: As no trials were identified, no formal analysis was performed., Authors' Conclusions: On the basis of current evidence, population-based screening for chronic OAG cannot be recommended, although much can be done to improve awareness and encourage at risk individuals to seek testing. In wealthy countries with equitable access to high quality eye care and health education, blindness from chronic OAG should become increasingly rare; much greater challenges face poor and emerging economies and countries where there are substantial health and wealth inequalities. Effectiveness of screening for OAG can be established only by high quality RCTs.
- Published
- 2006
- Full Text
- View/download PDF
15. Surgical interventions for age-related cataract.
- Author
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Riaz Y, Mehta JS, Wormald R, Evans JR, Foster A, Ravilla T, and Snellingen T
- Subjects
- Age Factors, Humans, Phacoemulsification, Randomized Controlled Trials as Topic, Cataract Extraction methods
- Abstract
Background: Cataract accounts for 50% of blindness globally and remains the leading cause of visual impairment in all regions of the world, despite improvements in surgical outcomes (WHO 2005). This number is expected to rise due to an aging population and increase in life expectancy. Although cataracts are not preventable, their surgical treatment is one of the most cost-effective interventions in healthcare., Objectives: To compare the effects of different surgical interventions for age-related cataract., Search Strategy: We searched CENTRAL, MEDLINE, EMBASE up to July 2006, NRR Issue 3 2005, the reference lists of identified trials and we contacted investigators and experts in the field for details of published and unpublished trials., Selection Criteria: We included randomised controlled trials (RCTS)., Data Collection and Analysis: Two review authors independently extracted data and discrepancies were resolved by discussion. Where appropriate, risk ratios, odds ratios and weighted mean differences were summarised after assessing heterogeneity between the studies., Main Results: We identified 17 trials that randomised a total of 9627 people. Phacoemulsification gave a better visual outcome than extracapsular surgery but similar average cost per procedure in Europe but not in poorer countries. Extracapsular surgery with posterior chamber lens implant and ICCE with or without an anterior chamber intraocular lens (IOL) implant gave acceptable visual outcomes but extracapsular surgery had less complications. Manual small incision surgery provides better visual outcome than ECCE but slightly inferior unaided visual acuity compared to phacoemulsification., Authors' Conclusions: This review provides evidence from seven RCTs that phacoemulsification gives a better outcome than ECCE with sutures. We also found evidence that ECCE with a posterior chamber lens implant provides better visual outcome than ICCE with aphakic glasses. The long term effect of posterior capsular opacification (PCO) needs to be assessed in larger populations. The data also suggests that ICCE with an anterior chamber lens implant is an effective alternative to ICCE with aphakic glasses, with similar safety. Phacoemulsification provides the best visual outcomes but will only be accessible to the poorer countries if the cost of phacoemulsification and foldable IOLs decrease. Manual small incision cataract surgery provides early visual rehabilitation and comparable visual outcome to PHACO. It has better visual outcomes than ECCE and can be used in any clinic that is currently carrying out ECCE with IOL. Further research from developing regions are needed to compare the cost and longer term outcomes of these procedures e.g. PCO and corneal endothelial cell damage.
- Published
- 2006
- Full Text
- View/download PDF
16. Intra-operative mitomycin C for glaucoma surgery.
- Author
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Wilkins M, Indar A, and Wormald R
- Subjects
- Antimetabolites adverse effects, Humans, Intraoperative Period, Mitomycin adverse effects, Randomized Controlled Trials as Topic, Treatment Failure, Antimetabolites therapeutic use, Cicatrix prevention & control, Glaucoma surgery, Mitomycin therapeutic use, Trabeculectomy adverse effects
- Abstract
Background: Trabeculectomy is performed as a treatment for glaucoma to lower the intraocular pressure (IOP). Mitomycin C (MMC) is an antimetabolite used during the initial stages of a trabeculectomy to prevent excessive postoperative scarring and thus reduce the risk of failure., Objectives: To assess the effects of intraoperative MMC compared to placebo in trabeculectomy., Search Strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) on The Cochrane Library (Issue 1, 2005), MEDLINE (1966 to March 2005), EMBASE (1985 to 20 March 2005), SIGLE (1980 to December 2004), the National Research Register (Issue 1, 2005), LILACS (29 March 2005) and reference lists of articles. We also contacted researchers in the field., Selection Criteria: We included randomised trials of intraoperative MMC compared to placebo in trabeculectomy surgery., Data Collection and Analysis: Two authors independently assessed trial quality and extracted data. We contacted trial investigators for missing information., Main Results: Eleven trials, involving a total of 698 participants, were included. The trials enrolled three types of participants (high risk of failure, trabeculectomy combined with cataract surgery, no previous surgical intervention). Mitomycin C appears to reduce the relative risk of failure of trabeculectomy both in eyes at high risk of failure (relative risk 0.32, 95% confidence interval 0.20 to 0.53) and those undergoing surgery for the first time (relative risk 0.29, 95% confidence interval 0.16 to 0.53). No significant effect on failure was noted in the group undergoing trabeculectomy combined with cataract extraction. Mean IOP was significantly reduced at 12 months in all three participant groups receiving MMC compared to placebo. No significant increase in permanent sight-threatening complications was detected. However, none of the trials were large enough or of sufficient duration to address the long-term risk of bleb infection and endophthalmitis which has been reported in observational studies. Some evidence exists that MMC increases the risk of cataract., Authors' Conclusions: Intraoperative MMC reduces the risk of surgical failure in eyes that have undergone no previous surgery and in eyes at high risk of failure. Compared to placebo it reduces mean IOP at 12 months in all groups of participants in this review. Apart from an increase in cataract formation following MMC, there was insufficient power to detect any increase in other serious side effects such as endophthalmitis.
- Published
- 2005
- Full Text
- View/download PDF
17. Photodynamic therapy for neovascular age-related macular degeneration.
- Author
-
Wormald R, Evans J, Smeeth L, and Henshaw K
- Subjects
- Glucose therapeutic use, Humans, Porphyrins therapeutic use, Randomized Controlled Trials as Topic, Verteporfin, Macular Degeneration drug therapy, Photochemotherapy, Photosensitizing Agents therapeutic use, Retinal Neovascularization drug therapy
- Abstract
Background: In neovascular age-related macular degeneration (AMD) new vessels grow under the retina distorting vision and leading to scarring. This is exacerbated if the blood vessels leak. Photodynamic therapy (PDT) has been investigated as a way to treat the neovascular membranes without affecting the retina., Objectives: The aim of this review was to examine the effects of PDT in the treatment of neovascular AMD., Search Strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which includes the Cochrane Eyes and Vision Group Trials Register) on The Cochrane Library (Issue 1, 2005), MEDLINE (1966 to January 2005), EMBASE (1980 to January 2005). We used the Science Citation Index to search for reports that cited relevant studies. We contacted experts in the field and searched the reference lists of relevant studies., Selection Criteria: We included randomised trials of PDT in people with choroidal neovascularisation due to AMD., Data Collection and Analysis: Two authors independently extracted the data. Relative risks were combined using a fixed-effect model after testing for heterogeneity., Main Results: Two published trials were identified that randomised 948 participants to verteporfin therapy compared to 5% dextrose in water. Both trials were performed by the same investigators using largely the same clinical centres and funded by manufacturers of verteporfin. Outcome data were available at 12 and 24 months after the first treatment. Participants received on average five treatments over two years. The relative risk of losing three or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.77 (95% confidence interval 0.69 to 0.87). The relative risk of losing six or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.62 (95% confidence interval 0.50 to 0.76). The results at 12 months were similar to those at 24 months. The most serious adverse outcome, acute (within 7 days of treatment) severe visual acuity decrease, occurs in about one in 50 patients., Authors' Conclusions: Photodynamic therapy in people with choroidal neovascularisation due to AMD is probably effective in preventing visual loss though there is doubt about the size of the effect. Outcomes and potential adverse effects of this treatment should be monitored closely. Further independent trials of verteporfin are required to establish that the effects seen in this study are consistent and to examine important issues not yet addressed, particularly relating to quality of life and cost.
- Published
- 2005
- Full Text
- View/download PDF
18. Photodynamic therapy for neovascular age-related macular degeneration.
- Author
-
Wormald R, Evans J, Smeeth L, and Henshaw K
- Subjects
- Glucose therapeutic use, Humans, Porphyrins therapeutic use, Randomized Controlled Trials as Topic, Verteporfin, Macular Degeneration drug therapy, Photochemotherapy, Photosensitizing Agents therapeutic use, Retinal Neovascularization drug therapy
- Abstract
Background: In neovascular age-related macular degeneration, new vessels grow under the retina, distorting vision and leading to scarring. This is further exacerbated if the blood vessels leak. Photodynamic therapy, originally used in cancer treatment, has been investigated as a way to treat the neovascular membranes without affecting the retina., Objectives: The aim of this review is to examine the effects of photodynamic therapy in the treatment of neovascular age-related macular degeneration., Search Strategy: We searched for trials in the Cochrane Central Register of Controlled Trials - CENTRAL (which includes the Cochrane Eyes and Vision Group trials register) on the Cochrane Library (Issue 4 2002), MEDLINE (1966 to November 2002) and EMBASE (1980 to November 2002). We used the Science Citation Index to search for reports that cited relevant study reports. We contacted experts in the field and we searched the reference lists of relevant studies for further trial reports., Selection Criteria: We included randomised trials of photodynamic therapy in people with choroidal neovascularisation due to age-related macular degeneration., Data Collection and Analysis: Two reviewers extracted the data independently. Relative risks were combined using a fixed effect model after testing for heterogeneity using a chi-square test., Main Results: Two published trials were identified that randomised 948 participants to verteporfin therapy compared to 5% dextrose in water. Both trials were performed by the same investigators using largely the same clinical centres and funded by manufacturers of verteporfin. Outcome data were available at 12 and 24 months after the first treatment. Participants received on average five treatments over two years. The relative risk of losing three or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.77 (95% confidence interval 0.69 to 0.87). The relative risk of losing six or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.62 (95% confidence interval 0.50 to 0.76). The results at 12 months were similar to those at 24 months., Reviewer's Conclusions: Photodynamic therapy in people with choroidal neovascularisation due to age-related macular degeneration is effective in preventing visual loss. Outcomes and potential adverse effects of this treatment should be monitored closely. Further independent trials of Verteporfin are required to establish that the effects seen in this study are consistent and to determine important questions not yet addressed, particularly relating to quality of life and cost.
- Published
- 2003
- Full Text
- View/download PDF
19. Ivermectin for onchocercal eye disease (river blindness).
- Author
-
Ejere H, Schwartz E, and Wormald R
- Subjects
- Humans, Randomized Controlled Trials as Topic, Anthelmintics therapeutic use, Ivermectin therapeutic use, Onchocerciasis, Ocular drug therapy
- Abstract
Background: It is believed that ivermectin (a microfilaricide) could prevent blindness due to onchocerciasis. However, when given to everyone in communities where onchocerciasis is common, the effects of ivermectin on lesions affecting the eye are uncertain and data on whether the drug prevents visual loss is unclear., Objectives: The aim of this review is to assess the effectiveness of ivermectin in preventing visual acuity and visual field loss in onchocercal eye disease. The secondary aim is to assess the effects of ivermectin on lesions affecting the eye in onchocerciasis., Search Strategy: We searched the Cochrane Eyes and Vision Group specialised register, the Cochrane Controlled Trials Register - CENTRAL, MEDLINE, EMBASE, the reference lists of identified trials, the Science Citation Index and we contacted investigators, experts and pharmaceutical companies to identify additional trials., Selection Criteria: We included randomised controlled trials with at least one year follow up, comparing ivermectin at a dose of 150 micrograms per kilogram of body weight with either placebo or no treatment. Participants were people normally resident in endemic onchocercal communities with or without one or more characteristic signs of ocular onchocerciasis., Data Collection and Analysis: Two reviewers independently extracted data and assessed trial quality. Study authors were contacted for additional information. Trials varied in design and setting, so no meta-analysis was done., Main Results: This review includes five trials with data from 3810 participants. All the trials compared ivermectin with placebo and were judged to be of moderate risk of bias in terms of methodological quality. No statistically significant difference was observed in any trial (reporting visual acuity outcome) between ivermectin and placebo groups for visual acuity loss., Reviewer's Conclusions: Questions about the effectiveness of ivermectin in preventing visual acuity loss have not been answered by best available evidence.
- Published
- 2001
- Full Text
- View/download PDF
20. Photodynamic therapy for neovascular age-related macular degeneration.
- Author
-
Wormald R, Evans J, Smeeth L, and Henshaw K
- Subjects
- Humans, Randomized Controlled Trials as Topic, Macular Degeneration drug therapy, Photochemotherapy, Photosensitizing Agents therapeutic use, Retinal Neovascularization drug therapy
- Abstract
Background: In neovascular age-related macular degeneration, new vessels grow under the retina, distorting vision and leading to scarring. This is further exacerbated if the blood vessels leak. Photodynamic therapy, originally used in cancer treatment, has been investigated as a way to treat the neovascular membranes without affecting the retina., Objectives: The aim of this review is to examine the effects of photodynamic therapy in the treatment of neovascular age-related macular degeneration., Search Strategy: We searched for trials in the Cochrane Controlled Trials Register - CENTRAL (which includes the Cochrane Eyes and Vision Group specialised register), MEDLINE and EMBASE. We used the Science Citation Index to search for reports that cited relevant study reports. We contacted experts in the field and we searched the reference lists of relevant studies for further trial reports., Selection Criteria: We included randomised trials of photodynamic therapy in people with choroidal neovascularisation due to age-related macular degeneration., Data Collection and Analysis: Two reviewers extracted the data independently. As only one trial met the inclusion criteria, meta-analysis was not performed., Main Results: One published trial was identified which randomised 609 participants. Outcome data were available at 12 and 24 months after the first treatment. Participants in the treatment group received an average of 3.4 treatments in the first year, and 2.2 in the second year. The relative risk of losing three or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.75 (95% confidence interval 0.65 to 0.88). The relative risk of losing six or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.61 (95% confidence interval 0.45 to 0.81). The results at 12 months were similar to those at 24 months. Subgroup analyses suggest that the benefits may be confined to people with no occult choroidal neovascularisation., Reviewer's Conclusions: Photodynamic therapy in people with classic choroidal neovascularisation due to age-related macular degeneration is effective in preventing visual loss. This evidence is drawn from a subgroup analysis of 143 participants in one trial. Outcomes and potential adverse effects of this treatment should be monitored closely. There is no evidence that photodynamic therapy is beneficial for people with evidence of occult choroidal neovascularisation. These people should be offered treatment only in the context of a randomised trial.
- Published
- 2001
- Full Text
- View/download PDF
21. Post-operative 5-Fluorouracil for glaucoma surgery.
- Author
-
Wormald R, Wilkins MR, and Bunce C
- Subjects
- Cicatrix prevention & control, Humans, Wound Healing drug effects, Antimetabolites therapeutic use, Fluorouracil therapeutic use, Glaucoma drug therapy, Glaucoma surgery, Trabeculectomy
- Abstract
Background: Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intra-ocular pressure. The surgery involves creating a channel through the sclera, through which intra-ocular fluid can leave the eye. If scar tissue blocks the exit of the surgically created channel intra-ocular pressure rises and the operation fails. Antimetabolites such as 5-Fluorouracil are used to inhibit wound healing to prevent the conjunctiva scarring down on to the sclera., Objectives: The objective of this review is to assess the effects of post-operative injections of 5-Fluorouracil in eyes of people undergoing surgery for glaucoma., Search Strategy: We searched the Cochrane Controlled Trials Register - CENTRAL (which includes the Cochrane Eyes and Vision Group specialised register), MEDLINE and EMBASE. We searched the reference lists of relevant articles for additional trials, and we used the Science Citation Index to search for articles that cited the included studies. We contacted investigators and experts for details of additional relevant trials., Selection Criteria: We included randomised trials of post-operative 5-Fluorouracil injections compared to placebo injections or no injections in trabeculectomy for glaucoma., Data Collection and Analysis: Two reviewers independently assessed trial quality and extracted data. We contacted trial investigators for missing information. Data were summarised using relative risk, Peto odds ratio and weighted mean difference as appropriate., Main Results: Nine trials, which randomised a total of 614 participants, are included in the review. As far as can be determined from the trial reports, the methodological quality of the trials was not high. When delivered by post-operative injection, 5-Fluorouracil appears to be effective in reducing the likelihood of surgical failure of trabeculectomy both in eyes at high risk of failure and those undergoing surgery for the first time. The results suggest that injection of low doses of 5-Fluorouracil may not be effective. Whilst no evidence was found of an increased risk of serious sight threatening complications, other complications are more common after 5-Fluorouracil injections. None of the trials reported on the participants' perspective of care., Reviewer's Conclusions: Post-operative injections of 5-Fluorouracil are now rarely used as a planned series but are increasingly used on an ad hoc basis. This presumably reflects an aspect of the treatment that is unacceptable to both patients and doctors. None of the trials reported on the participants' perspective of care which constitutes a serious omission for an invasive treatment such as this.
- Published
- 2001
- Full Text
- View/download PDF
22. Intra-operative mitomycin C for glaucoma surgery.
- Author
-
Wilkins M, Indar A, and Wormald R
- Subjects
- Cataract Extraction, Humans, Intraoperative Period, Randomized Controlled Trials as Topic, Treatment Failure, Antimetabolites therapeutic use, Cicatrix prevention & control, Glaucoma surgery, Mitomycin therapeutic use, Trabeculectomy adverse effects
- Abstract
Background: Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intra-ocular pressure. Mitomycin C is an antimetabolite applied between the sclera and conjunctiva during the initial stages of a trabeculectomy to prevent excessive post-operative scarring and thus reduce the risk of failure., Objectives: The objective of this review is to assess the effects of intra-operative application of mitomycin C in eyes of people undergoing trabeculectomy., Search Strategy: We searched the Cochrane Eyes and Vision Group specialised register, The Cochrane Controlled Trials Register - CENTRAL, MEDLINE, EMBASE and the reference lists of relevant articles. We used the Science Citation Index to search for articles that cited the included studies. We contacted investigators and experts for details of additional relevant trials., Selection Criteria: We included randomised trials of intra-operative mitomycin C compared to placebo in trabeculectomy., Data Collection and Analysis: Two reviewers independently assessed trial quality and extracted data. We contacted trial investigators for missing information. Data were summarised using relative risk, odds ratio and weighted mean difference., Main Results: This review includes 11 trials involving a total of 698 participants. The trials included three types of participants (those at high risk of failure, those undergoing trabeculectomy combined with cataract surgery, and those with no previous surgical intervention). Mitomycin C appears to be effective in reducing the relative risk of failure of trabeculectomy both in eyes at high risk of failure (relative risk 0.32, 95% confidence interval 0.20 to 0.53) and those undergoing surgery for the first time (relative risk 0.29, 95% confidence interval 0.16 to 0.53). No significant effect on failure was noted in the group undergoing trabeculectomy combined with cataract extraction. Mean intra-ocular pressure was significantly reduced at 12 months in all three participant groups receiving mitomycin C compared to placebo. No significant increase in permanent sight threatening complications was detected. Some evidence exists that mitomycin C increases the risk of cataract. The quality of trial reporting is poor in eight trials. Repeat analysis with three trials rated as low risk of bias did not yield different results., Reviewer's Conclusions: Intra-operative mitomycin C reduces the risk of surgical failure in eyes that have undergone no previous surgery and in eyes at high risk of failure. Compared to placebo it reduces mean intra-ocular pressure at 12 months in all groups of participants in this review. Apart from an increase in cataract formation following mitomycin C, no demonstrable significant increase in other side effects was detected.
- Published
- 2001
- Full Text
- View/download PDF
23. Photodynamic therapy for neovascular age-related macular degeneration.
- Author
-
Wormald R, Evans J, and Smeeth L
- Subjects
- Humans, Neovascularization, Pathologic, Macular Degeneration drug therapy, Photochemotherapy, Photosensitizing Agents therapeutic use
- Abstract
Background: In neovascular age-related macular degeneration, new vessels grow under the retina, distorting vision and leading to scarring. This is further exacerbated if the blood vessels leak. Photodynamic therapy, originally used in cancer treatment, has been investigated as a way to treat the neovascular membranes without affecting the retina., Objectives: The aim of this review is to examine the evidence for the safety and effectiveness of photodynamic therapy in the treatment of neovascular age-related macular degeneration., Search Strategy: We searched for trials in the Cochrane Eyes and Vision Group trials register (available in the Cochrane Controlled Trials Register), the Cochrane Controlled Trials Register, Medline and Embase. We used the Science Citation Index to search for reports that cited identified relevant study reports. We contacted experts in the field for further trials information, and we searched the reference lists of identified relevant studies for further trial reports. Searches were conducted in December 1999., Selection Criteria: We included randomised trials of photodynamic therapy in people with choroidal neovascularisation due to age-related macular degeneration., Data Collection and Analysis: Two reviewers extracted the data independently. Meta analysis was not performed., Main Results: One published trial was identified. Outcome data were available at 12 months after the first treatment. Patients received an average of 3.7 treatments. The relative risk of losing three or more lines of visual acuity at 12 months comparing the intervention with the control group was 0.72 (95% confidence interval 0.61 to 0.86). The relative risk of losing six or more lines of visual acuity at 12 months comparing the intervention with the control group was 0.62 (95% confidence interval 0.44 to 0.87). Subgroup analyses suggest that the benefits may be confined to people with no occult choroidal neovascularisation., Reviewer's Conclusions: Photodynamic therapy in people with classic choroidal neovascularisation due to age-related macular degeneration is effective in preventing visual loss. This evidence is drawn from a subgroup analysis of 143 participants in one trial. Outcomes and potential adverse effects of this treatment should be monitored closely. There is no evidence that photodynamic therapy is beneficial for people with evidence of occult choroidal neovascularisation. These people should be offered treatment in the context of a randomised trial.
- Published
- 2000
- Full Text
- View/download PDF
24. Post-operative 5-fluorouracil for glaucoma surgery.
- Author
-
Wormald R, Wilkins MR, and Bunce C
- Subjects
- Humans, Antimetabolites therapeutic use, Fluorouracil therapeutic use, Glaucoma drug therapy, Glaucoma surgery, Trabeculectomy
- Abstract
Background: Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intra-ocular pressure. The surgery involves creating a channel through the sclera, through which intra-ocular fluid can leave the eye. If scar tissue blocks the exit of the surgically created channel intra-ocular pressure rises and the operation fails. Antimetabolites are used to inhibit wound healing to prevent the conjunctiva scarring down on to the sclera. The principal antimetabolites used are 5-Fluorouracil and Mitomycin C. Both may be applied on a sponge between the conjunctiva and sclera at the beginning of surgery. 5-Fluorouracil may also be given as one or more injections under the conjunctiva after the surgery., Objectives: The objective of this review is to assess the effects of post-operative injections of 5-Fluorouracil in eyes of people undergoing surgery for glaucoma., Search Strategy: We searched the Cochrane Eyes and Vision Group specialised register, The Cochrane Controlled Trials Register (CENTRAL), MEDLINE and EMBASE. We searched the reference lists of relevant articles for additional trials, and we used the Science Citation Index to search for articles that cited the included studies. We contacted investigators and experts for details of additional relevant trials., Selection Criteria: We included randomised trials of post-operative 5-Fluorouracil injections compared to placebo injections or no injections in trabeculectomy for glaucoma., Data Collection and Analysis: We independently assessed trial quality and extracted data. We contacted trial investigators for missing information. Data were summarised using relative risk, Peto odds ratio and weighted mean difference as appropriate., Main Results: Eight trials, which randomised a total of 536 participants, are included in the review. As far as can be determined from the trial reports, the methodological quality of the trials was not high. 5-Fluorouracil when delivered by post-operative injection appears to be effective in reducing the likelihood of surgical failure of trabeculectomy both in eyes at high risk of failure and those undergoing surgery for the first time. Complications are more common after 5-Fluorouracil injections, especially early and late wound leaks and temporary damage to the ocular surface. Whilst no evidence was found of an increased risk of serious sight threatening complications, people undergoing initial trabeculectomy had a substantially increased risk of ocular hypotony. None of the trials reported on the participants' perspective of care., Reviewer's Conclusions: This treatment is now rarely used on the basis of a planned series of post-operative injections.This presumably reflects an aspect of the treatment that is unacceptable to both patients and doctors. None of the trials reported on the participants' perspective of care which constitutes a serious omission for an invasive treatment such as this. Increasingly, injections are used on an ad hoc basis. The effectiveness of this strategy is the subject of a future systematic review.
- Published
- 2000
- Full Text
- View/download PDF
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