Search

Background: Vitreous hemorrhage from proliferative diabetic retinopathy can cause severe vision loss. DRCR Retina Network Protocol AB was a randomized clinical trial comparing intravitreal aflibercept versus vitrectomy with panretinal photocoagulation and found no difference in the average rate of visual recovery over 104 weeks. Herein, we describe patient-reported outcome measures from Protocol AB. Methods: Secondary analysis of a multicenter (39 sites) randomized clinical trial. The Work Productivity and Activity Impairment Questionnaire was administered at 4, 12, 24, 36, 52, 68, 84, and 104 weeks. Main outcomes were mean change in activity impairment and work productivity loss over 24 and 104 weeks (area under the curve). Results: Mean (SD) activity impairment at baseline was 58% (27%) in the aflibercept group (N = 99) and 56% (30%) in the vitrectomy group (N = 105). The mean reduction in activity impairment from baseline over 24 weeks was 21% (25%) in the aflibercept group and 27% (31%) in the vitrectomy group (adjusted difference = -6.8% [95% CI, -12.7% to -0.9%], P =.02); over 104 weeks, the adjusted mean difference was -3.1% (95% CI, -9.2% to 3.0%, P =.31). Mean work productivity loss at baseline was 51% (28%) in the aflibercept group (N = 44) and 58% (30%) in the vitrectomy group (N = 43). The mean reduction in work productivity loss from baseline over 24 weeks (area under the curve) was 19% (23%) in the aflibercept group and 31% (24%) in the vitrectomy group (adjusted difference = -8.3% [95% CI, -16.8% to 0.2%], P =.06); over 104 weeks, the adjusted mean difference was -9.1% (95% CI, -18.4% to 0.2%, P =.05). Conclusions: Participants with vitreous hemorrhage from proliferative diabetic retinopathy had less activity impairment over 24 weeks when treated initially with vitrectomy and panretinal photocoagulation versus intravitreal aflibercept. The trend was similar for work productivity but not statistically significant. By 104 weeks, the improvements were similar in the two treatment groups. Trial registration: ClinicalTrials.gov NCT02858076. [ABSTRACT FROM AUTHOR]

Importance: Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown.Objective: To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy.Design, Setting, and Participants: Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020.Interventions: Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria.Main Outcomes and Measures: The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years.Results: Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept.Conclusions and Relevance: Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation.Trial Registration: ClinicalTrials.gov Identifier: NCT02858076. [ABSTRACT FROM AUTHOR]

Importance: Intravitreous injections of antivascular endothelial growth factor agents are effective for treating diabetic macular edema (DME) involving the center of the macula (center-involved DME [CI-DME]) with visual acuity impairment (20/32 or worse). The best approach to treating patients with CI-DME and good visual acuity (20/25 or better) is unknown.Objective: To compare vision loss at 2 years among eyes initially managed with aflibercept, laser photocoagulation, or observation.Design, Setting, and Participants: Randomized clinical trial conducted at 91 US and Canadian sites among 702 adults with type 1 or type 2 diabetes. Participants had 1 study eye with CI-DME and visual acuity of 20/25 or better. The first participant was randomized on November 8, 2013, and the final date of follow-up was September 11, 2018.Interventions: Eyes were randomly assigned to 2.0 mg of intravitreous aflibercept (n = 226) as frequently as every 4 weeks, focal/grid laser photocoagulation (n = 240), or observation (n = 236). Aflibercept was required for eyes in the laser photocoagulation or observation groups that had decreased visual acuity from baseline by at least 10 letters (≥ 2 lines on an eye chart) at any visit or by 5 to 9 letters (1-2 lines) at 2 consecutive visits.Main Outcomes and Measures: The primary outcome was at least a 5-letter visual acuity decrease from baseline at 2 years. Antiplatelet Trialists' Collaboration adverse events (defined as myocardial infarction, stroke, or vascular or unknown death) were reported.Results: Among 702 randomized participants (mean age, 59 years; 38% female [n=264]), 625 of 681 (92% excluding deaths) completed the 2-year visit. For eyes with visual acuity that decreased from baseline, aflibercept was initiated in 25% (60/240) and 34% (80/236) in the laser photocoagulation and observation groups, respectively. At 2 years, the percentage of eyes with at least a 5-letter visual acuity decrease was 16% (33/205), 17% (36/212), and 19% (39/208) in the aflibercept, laser photocoagulation, and observation groups, respectively (aflibercept vs laser photocoagulation risk difference, -2% [95% CI, -9% to 5%]; relative risk, 0.88 [95% CI, 0.57-1.35; P = .79]; aflibercept vs observation risk difference, -3% [95% CI, -11% to 4%]; relative risk, 0.83 [95% CI, 0.55-1.27; P = .79]; laser photocoagulation vs observation risk difference, -1% [95% CI, -9% to 6%]; relative risk, 0.95 [95% CI, 0.64-1.41; P = .79]). Antiplatelet Trialists' Collaboration vascular events occurred in 15 (7%), 13 (5%), and 8 (3%) participants in the aflibercept, laser photocoagulation, and observation groups.Conclusions and Relevance: Among eyes with CI-DME and good visual acuity, there was no significant difference in vision loss at 2 years whether eyes were initially managed with aflibercept or with laser photocoagulation or observation and given aflibercept only if visual acuity worsened. Observation without treatment unless visual acuity worsens may be a reasonable strategy for CI-DME.Trial Registration: ClinicalTrials.gov Identifier: NCT01909791. [ABSTRACT FROM AUTHOR]

Vitreoretinal surgery is performed using mechanical dissection that sometimes results in iatrogenic complications, including vitreous hemorrhage, retinal breaks, incomplete membrane delamination, retinal distortion, microscopic damage, etc. An ultraprecise laser probe would be an ideal tool for cutting away pathologic membranes; however, the depth of surgery should be precisely controlled to protect the sensitive underlying retina. The ultraprecise surgical microprobe formed by chains of dielectric spheres for use with the erbium: YAG laser source (λ = 2940 nm), with extremely short optical penetration depth in tissue, was optimized. Numerical modeling demonstrated a potential advantage of five-sphere focusing chains of sapphire spheres with index n = 1.71 for ablating the tissue with self-limited depth around 10 to 20 µm. Novel detachable microsphere scalpel tips formed by chains of 300 µm sapphire (or ruby) spheres were tested on ophthalmic tissues, ex vivo. Detachable scalpel tips could allow for reusability of expensive mid-infrared trunk fibers between procedures, and offer more surgical customization by interchanging various scalpel tip configurations. An innovative method for aiming beam integration into the microsphere scalpel to improve the illumination of the surgical site was also shown. Single Er:YAG pulses of 0.2 mJ and 75-µs duration produced ablation craters in cornea epithelium for one, three, and five sphere structures with the latter generating the smallest crater depth (10 µm) with the least amount of thermal damage depth (30 µm). Detachable microsphere laser scalpel tips may allow surgeons better precision and safety compared to mechanical scalpels when operating on delicate or sensitive areas like the retina [ABSTRACT FROM AUTHOR]

Objective: To describe characteristics of the Age- Related Eye Disease Study (AREDS) 9-step severity scale applied to participants in the Complications of Agerelated Macular Degeneration Prevention Trial (CAPT). Methods: Eligibility criteria for CAPT required 10 or more large (⩾125 μm) drusen in each eye. Readers graded baseline photographs from all participants and all follow-up photographs from 402 untreated eyes. Drusen and pigment characteristics were used to assign the AREDS scale score. Choroidal neovascularization was identified from fluorescein angiograms. Geographic atrophy involving the macular center was identified from color photographs. Results: Among 1001 untreated eyes, 90% were at steps 5 to 7 at baseline. The 5-year incidence of advanced agerelated macular degeneration (AMD) increased with each step from 8% (step 4) to 40% (steps 8 and 9 combined). These rates were similar to those reported in AREDS. Among 261 eyes with all 5 annual photograph gradings available and without progression to advanced AMD, 55% of eyes had scores that indicated improvement at least once. Before progression to advanced AMD, only 32% of 141 eyes either went through step 8 or 9 or had an increase of 2 or more steps from baseline. Conclusions: The AREDS 9-step severity scale was predictive of development of advanced AMD. The AREDS scale has deficiencies as a surrogate outcome for progression to advanced AMD. [ABSTRACT FROM AUTHOR]

The article discusses issues and concerns in converting to Electronic Medical Records (EMR). It notes that installing an EMR system requires expertise in information technology (IT), which will incur additional costs for necessary IT support and overtime work required. An EMR software package should contain a set of defined retina-based templates and screens that provide a starting point for physician exam documents. It is also mentioned that staff should be measured for their technology skill level prior to using the EMR.

Objective: An examination of clinically relevant subgroups of patients in the MARINA study of ranibizumab in treatment of minimally classic or occult with no classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) was done. Objectives were to determine the effectiveness of ranibizumab across subgroups, compare the effectiveness of ranibizumab with that of sham injection within subgroups, and evaluate the relationship between selected baseline characteristics and visual acuity (VA) outcomes. Design: Retrospective subgroup analyses of 24-month data from the MARINA study. Participants and Controls: Seven hundred sixteen patients were randomly assigned to 0.3 mg ranibizumab (n = 238), 0.5 mg ranibizumab (n = 240), or sham treatment (n = 238). Methods: Efficacy outcomes were compared across subgroups based on patients’ gender, age, baseline VA score, baseline CNV lesion size, CNV lesion type, and duration of neovascular AMD using univariate analyses. Multivariate analyses were performed on the change from baseline to 24 months in VA score to assess further the correlation between baseline characteristics and VA outcome. Main Outcome Measures: Proportion of patients losing <15 letters from baseline, proportion gaining ≥15 letters from baseline, and mean VA score change from baseline. Results: For each of the 3 VA end points, all subgroups of ranibizumab-treated patients did better on average than the sham-treated patients. Increasing age, larger CNV lesion size at baseline, and a higher baseline VA score were all associated with greater loss of letters in the sham group or less gain of letters in the ranibizumab groups. However, the net benefit of ranibizumab versus sham treatment was greater in patients who scored higher than in those who scored lower in baseline VA. Conclusions: This subgroup analysis of 24-month data from the MARINA study indicates that ranibizumab treatment was associated with an average increase from baseline VA in all subgroups evaluated, and that ranibizumab treatment was superior to sham treatment across all subgroups. The most important predictors of VA outcomes were, in decreasing order of importance, baseline VA score, CNV lesion size, and age. [Copyright &y& Elsevier]

The article discusses several lessons learned from an electronic medical records (EMR) system. One of the benefits of the EMR system is the quick availability of patients' records at any site. A limitation of EMR is the slow speed of the software, which affect patient visits. Several choices to be made upon the selection of an EMR system include the selection of hardware, software, office visit templates, templates for each procedure, fluorescein angiogram and the template of consult letters.

The article offers information on how to build an electronic medical record (EMR) solution. It states that at the most basic level, the proper cabling must be installed for the personal computers running EMR to communicate with the servers running the back-end application servers/database. It mentions that once the network cabling is taken care of, network equipment such as switches, routers and firewalls must be considered.

The article offers step-by-step instructions for choosing the appropriate electronic medical record (EMR) system for an ophthalmology practice.

The article provides information on the use of electronic medical records (EMR) as a means of saving money and reducing medical errors. In the U.S., the adoption rate of EMR is reportedly very low due to the private control of the healthcare sector, lack of funding to develop software and poor image management tools, to name a few. Ophthalmologists and retinal physicians are using the Electronic Practice Management software to meet the accountability and compliance requirements of clinical charting.

The article focuses on clinically significant diabetic macular edema (CSDME). It mentions that CSDME is based on a clinician's subjective assessment of the fundus. It discloses that subclinical diabetic macular edema is recognized clinically but does not rise to the level of being clinically significant. Several clinical questions are presented on various issues such as the rate of conversion from subclinical edema to clinically significant edema. The article conclusion is also presented.

: PurposeTo report a side effect of transpupillary thermotherapy for choroidal melanoma.: DesignSmall case series.: MethodsReview of clinical charts and photographs in a private retina practice.: ResultsRetinal tears developed in two patients after transpupillary thermotherapy for choroidal melanoma. In one patient a secondary rhegmatogenous retinal detachment developed.: ConclusionsTranspupillary thermotherapy can result in vitreous traction on the retina over the choroidal tumor, which can lead to a retinal tear and to retinal detachment. Patients should be warned about this possibility and advised to be examined should photopsias or new floaters develop after treatment. [Copyright &y& Elsevier]

Objective: To assess safety of repeated intravitreal injections of ranibizumab in treating neovascular age-related macular degeneration (AMD), and to assess changes in visual acuity (VA) and AMD lesion characteristics. Design: Multicenter, controlled, open-label, clinical trial. Participants: Sixty-four patients with subfoveal predominantly or minimally classic AMD-related choroidal neovascularization. Methods: In part 1, subjects were randomized to monthly intravitreal ranibizumab for 3 months (4 injections of 0.3 mg or 1 injection of 0.3 mg followed by 3 injections of 0.5 mg; n = 53) or usual care (UC; n = 11). In part 2, subjects could continue their regimen for 3 additional months or cross over to the alternative treatment. Main Outcome Measures: Adverse events (AEs), intraocular pressure (IOP), VA, and lesion characteristics assessed by fluorescein angiography and fundus photography. Results: Of the 64 randomized subjects, 62 completed the 6-month study. Twenty of 25 subjects (80%) randomized to 0.3 mg, and 22 of 28 subjects (79%) randomized to 0.5-mg ranibizumab in part 1 continued on that treatment in part 2; 9 of 11 (82%) subjects randomized to UC in part 1 crossed over to ranibizumab treatment in part 2. The most common AEs with ranibizumab were reversible inflammation and minor injection-site hemorrhages. Serious AEs were iridocyclitis, endophthalmitis, and central retinal vein occlusion (1 subject each). Postinjection, IOP increased transiently in 22.6% of ranibizumab-treated eyes in parts 1 and 2. After 4 ranibizumab injections (day 98), mean (± standard deviation) VA had increased 9.4±13.3 and 9.1±17.2 letters in the 0.3- and 0.5-mg groups, respectively, but had decreased 5.1±9.6 letters with UC. In part 2 (day 210), VA increased from baseline 12.8±14.7 and 15.0±14.2 letters in subjects continuing on 0.3 and 0.5 mg, respectively. Visual acuity improved from baseline ≥15 letters in 26% (day 98) and 45% (day 210) of subjects initially randomized to and continuing on ranibizumab, respectively, and areas of leakage and subretinal fluid decreased. No UC subject had a ≥15-letter improvement at day 98. Conclusions: Repeated intravitreal injections of ranibizumab had a good safety profile and were associated with improved VA and decreased leakage from choroidal neovascularization in subjects with neovascular AMD. [Copyright &y& Elsevier]

Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial. Multicenter cohort study. Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion). Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit. Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST). Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0–12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9–9.0) but decreased by 4.7 letters (95% CI, 3.3–6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3–14.5) better than baseline but 4.8 letters (95% CI, 2.5–7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4–5.0) better than baseline but 4.6 letters (95% CI, 3.1–6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142–166) and was stable between 2 and 5 years (−1 μm; 95% CI, −12 to 9). Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches. [ABSTRACT FROM AUTHOR]

The article discusses research which compared intravitreous aflibercept, bevacizumab and ranibizumab for the treatment of diabetic macular edema. Topics covered include the improvement in the mean visual-acuity letter score of study participants, the lack of significant differences in the rates of adverse events and hospitalization and the efficacy of aflibercept in improving vision.

Objective: To evaluate the long-term safety and efficacy of multiple intravitreal ranibizumab injections (Lucentis, Genentech, Inc., South San Francisco, CA) administered at the investigator''s discretion in patients with choroidal neovascularization secondary to age-related macular degeneration. Design: An open-label, multicenter, extension study. Participants: Patients who completed the controlled treatment phase of 1 of 3 prospective, randomized, 2-year clinical trials of ranibizumab were eligible for enrollment. Analyses were performed for 3 groups: (1) patients treated with ranibizumab in the initial study (ranibizumab treated-initial; n = 600); (2) patients randomized to control who crossed over to receive ranibizumab (ranibizumab treated-XO; n = 190); and (3) ranibizumab-naïve patients (ranibizumab untreated; n = 63). Methods: Ranibizumab 0.5 mg was administered at the investigator''s discretion. Adverse events (AEs) and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) assessments were conducted at study visits every 3 to 6 months. Main Outcome Measures: Incidence and severity of AEs. Results: There was 1 occurrence of mild endophthalmitis per 3552 HORIZON injections in the ranibizumab treated-initial/ranibizumab treated-XO groups. There were no serious AE reports of lens damage, retinal tears, or rhegmatogenous retinal detachments in the study eyes. The proportion of patients with any single postdose intraocular pressure ≥30 mmHg was 9.2%, 6.6%, and 0%, and the proportion of patients with glaucoma was 3.2%, 4.2%, and 3.2% in the ranibizumab treated-initial, ranibizumab treated-XO, and ranibizumab untreated groups, respectively. Cataract AEs were less frequent in the ranibizumab untreated group: 6.3% versus 12.5% and 12.1% in the ranibizumab treated-initial and ranibizumab treated-XO groups, respectively. The proportion of patients with arterial thromboembolic events as defined by the Antiplatelet Trialists'' Collaboration was 5.3% in the ranibizumab treated-initial and ranibizumab treated-XO groups, and 3.2% in the ranibizumab untreated group. At month 48 (2 years of HORIZON), the mean change in BCVA (ETDRS letters) relative to the initial study baseline was 2.0 in the ranibizumab treated-initial group versus −11.8 in the pooled ranibizumab treated-XO and ranibizumab untreated groups. Conclusions: Multiple ranibizumab injections were well tolerated for ≥4 years. With less frequent follow-up leading to less treatment, there was an incremental decline of the visual acuity (VA) gains achieved with monthly treatment. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. [Copyright &y& Elsevier]

Purpose: OPT-302 is a novel inhibitor of vascular endothelial growth factor (VEGF)-C and VEGF-D. A phase 1 trial assessed the safety of intravitreal OPT-302 as monotherapy or combined with ranibizumab (Lucentis; Genentech, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD)., Design: Open-label, dose escalation followed by a randomized dose expansion., Participants: Fifty-one patients with nAMD who were either treatment naïve (n = 25) or previously were treated with anti-VEGF A therapy (n = 26)., Methods: In the dose escalation, groups of 5 patients in 4 cohorts received ascending doses of OPT-302 (0.3 mg, 1 mg, or 2 mg) in combination with ranibizumab (0.5 mg), or as monotherapy (2 mg). In the dose expansion, 31 patients were randomized (3:1) to OPT-302 (2 mg) in combination with ranibizumab (n = 23) or as monotherapy (n = 8). Participants received three intravitreal treatments of OPT-302 once every 4 weeks either with or without ranibizumab., Main Outcome Measures: Safety and tolerability, OPT-302 pharmacokinetics and immunogenicity, effects on best-corrected visual acuity (BCVA), and anatomic changes., Results: Intravitreal OPT-302 with or without ranibizumab was well tolerated with low systemic exposure, no dose-limiting toxicities and no immunogenicity. In patients receiving OPT-302 monotherapy, 7 of 13 (54%) did not require rescue anti-VEGF-A therapy and the mean change in BCVA from baseline to week 12 was +5.6 letters (range, 0-18 letters). Mean BCVA gains from baseline to week 12 following combination OPT-302 with ranibizumab were +10.8 letters (95% confidence interval [CI], 4-17; n = 18) in treatment-naïve patients and +4.9 letters (95% CI, 3-7; n = 19) in previously treated patients, respectively. Corresponding reductions in mean central subfield thickness at week 12 in both groups were -119 μm (95% CI, -176 to -62 μm) and -54 μm (95% CI, -82 to -26 μm), respectively, whilst 50% of treatment-naïve patients also showed no detectable choroidal neovascularization at week 12 on fluorescein angiography., Conclusions: Intravitreal OPT-302 inhibition of VEGF-C and -D was well tolerated, and OPT-302 combination therapy may overcome an escape mechanism to VEGF-A suppression in the management of nAMD., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: A ranibizumab prefilled syringe (PFS) has been approved by the U.S. Food and Drug Administration. Here we evaluate the use of the ranibizumab PFS for intravitreal injection by assessing whether the PFS enables healthcare providers to successfully prepare and administer an injection without prior training., Design: Simulated-use and actual-use human factors usability studies., Participants: Retina specialists and ophthalmic medical personnel., Methods: In a simulated-use summative usability study, retina specialists (n = 15) and ophthalmic medical personnel (n = 15) prepared the ranibizumab PFS and performed injections into a model eye. In an actual-use formative usability study (ClinicalTrials.gov identifier: NCT02698566), three assistants and three retina specialists prepared the PFS and performed intravitreal injections, respectively, in study eyes of patients with retinal diseases (n = 35)., Main Outcome Measures: Twelve tasks specific to the unpacking, preparing, and properly administering the PFS for intravitreal injection were evaluated by a study assessor. Task performances were evaluated for use errors, close calls, and operational difficulties. Post-injection subjective user evaluations were performed to assess ease of use., Results: All participants successfully performed all essential and safety-critical tasks without use error in both the simulated-use and actual-use human factors usability studies. The majority of participants rated the tasks required to use the ranibizumab PFS as "Easy" or "Very Easy.", Conclusions: Both the simulated-use and actual-use usability studies yielded consistent data, showing that healthcare professionals are able to use the ranibizumab PFS by successfully performing all critical tasks involved in preparing and delivering an intravitreal injection. The simulated-use usability testing was sufficiently realistic and representative of real-world use, and was appropriate and preferred over actual-use usability testing for proper evaluation of the product user interface. LAY ABSTRACT: Ranibizumab is approved in the United States to treat various eye conditions, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. It is administered as an injection into the eye once a month, and is available in a vial from which medication needs to be withdrawn using a standard syringe with a 19-gauge filter needle. The filter needle is then replaced by a smaller gauge needle for the intravitreal injection. The recent U.S. Food and Drug Administration approval of a 0.5 mg ranibizumab prefilled syringe eliminates the need for withdrawing medication from a vial and changing needles prior to use. The studies described in this report assessed the usability of the ranibizumab prefilled syringe by retina specialists and ophthalmic medical personnel in simulated- and actual-use settings. Twelve tasks that included unpacking, preparing, and properly administering the prefilled syringe for intravitreal injection were evaluated by a study assessor. Task performances were evaluated for use errors, close calls, and operational difficulties. Participants successfully performed all the tasks without any critical errors in both simulated-use and actual-use human factors usability studies, and most participants found the syringe to be "Easy" or "Very Easy" to use., (© PDA, Inc. 2018.)

Ophthalmic surgery may benefit from use of more precise fiber delivery systems during laser surgery. Some current ophthalmic surgical techniques rely on tedious mechanical dissection of tissue layers. In this study, chains of sapphire microspheres integrated into a hollow waveguide distal tip are used for erbium:YAG laser ablation studies in contact mode with ophthalmic tissues, ex vivo. The laser's short optical penetration depth combined with the small spot diameters achieved with this fiber probe may provide more precise tissue removal. One-, three-, and five-microsphere chain structures were characterized, resulting in FWHM diameters of 67, 32, and 30 μm in air, respectively, with beam profiles comparable to simulations. Single Er:YAG pulses of 0.1 mJ and 75-μs duration produced ablation craters with average diameters of 44, 30, and 17 μm and depths of 26, 10, and 8 μm, for one-, three-, and five-sphere structures, respectively. Microsphere chains produced spatial filtering of the multimode Er:YAG laser beam and fiber, providing spot diameters not otherwise available with conventional fiber systems. Because of the extremely shallow treatment depth, compact focused beam, and contact mode operation, this probe may have potential for use in dissecting epiretinal membranes and other ophthalmic tissues without damaging adjacent retinal tissue.

Focusing of multimodal beams by chains of dielectric microspheres assembled directly inside the cores of hollow waveguides is studied by using numerical ray tracing. The device designs are optimized for laser surgery in contact mode with strongly absorbing tissue. By analyzing a broad range of parameters it is demonstrated that chains formed by three or five spheres with a refractive index of 1.65-1.75 provide a two-fold improvement in spatial resolution over single spheres at the cost of 0.2-0.4 attenuation in peak intensity of the central focused beam. Potential applications include ultra precise laser ablation or coagulation in the eye and brain, cellular surgery, and the coupling of light into photonic nanostructures.