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Purpose: To evaluate the long-term effect of laser trabeculoplasty (LTP) in patients randomized to multi-treatment in the Glaucoma Intensive Treatment Study (GITS). Methods: Patients with untreated newly diagnosed open-angle glaucoma were treated with three intraocular pressure (IOP)-lowering substances for 1 week and then 360 degrees argon or selective LTP was performed. IOP was measured just before LTP and repeatedly during the 60-month study period. Our previous report on 12 months follow-up data revealed no effect of LTP in eyes having an IOP <15 mmHg before the laser treatment. Results: Before LTP, the mean IOP +/- standard deviation in all 152 study-eyes of 122 multi-treated patients was 14.0 +/- 3.5 mmHg. Three eyes of three deceased patients were lost to follow-up during the 60 months. After exclusion of eyes that received increased therapy during follow-up, the IOP was significantly reduced at all visits up to 48 months in eyes with pre-LTP IOP >= 15 mmHg; 2.6 +/- 3.1 mmHg at 1 month and 1.7 +/- 2.8 mmHg at 48 months, n = 56 and 48, respectively. No significant IOP reduction was seen in eyes with pre-LTP IOP <15 mmHg. Seven eyes, i.e., <13%, with pre-LTP IOP >= 15 mmHg at baseline had required increased IOP-lowering therapy at 48 months. Conclusion: LTP performed in multi-treated patients may provide a useful IOP reduction that is maintained over several years. This was true on a group level when the initial IOP was >= 15 mmHg, but if the pre-laser IOP was lower than that, chances of LTP success were small., Originally included in thesis in manuscript form.

Purpose: To determine the effect of glaucomatous visual field (VF) damage close to the point of fixation, called threat-to-fixation (TTF), on vision-related quality of life (VRQoL) in open-angle glaucoma. Methods: A total of 239 patients from the Glaucoma Intensive Treatment Study (GITS) were included in this analysis. The second VF of patients with newly diagnosed primarily early glaucoma was evaluated for the presence or absence of TTF. TTF was defined as VF loss including one or more of the four innermost test points depressed at p < 1% in the total deviation probability map of Humphrey 24–2 SITA Standard visual fields. VRQoL was evaluated using Rasch-analysed National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) scores. The correlation between VRQoL and TTF was evaluated using uni- and multivariable regression analyses. Results: TTF was present in at least one eye in 115 patients (48%); located in the superior hemifield alone in 47% (54 of 115), in the inferior hemifield alone in 23% (27 of 115), and in 30% (34 of 115) in both hemifields. The median Rasch-calibrated NEI VFQ-25 scores were identical when comparing patients with TTF (VRQoL score 66, 95% CI: 23–100) and those with no-TTF (VRQoL score 66, 95% CI: 21–100) (p = 0.925). Neither the presence of TTF (R2 = −0.004, p = 0.968) nor the location of TTF (R2 = 0.023, p = 0.103) was significantly correlated to Rasch-calibrated NEI VFQ-25 scores. Conclusion: The presence of TTF did not influence VRQoL, as measured by the NEI-VFQ-25, in this relatively large group of patients with mainly early glaucoma.

Purpose: To evaluate the long-term effect of laser trabeculoplasty (LTP) in patients randomized to multi-treatment in the Glaucoma Intensive Treatment Study (GITS). Methods: Patients with untreated newly diagnosed open-angle glaucoma were treated with three intraocular pressure (IOP)-lowering substances for 1 week and then 360 degrees argon or selective LTP was performed. IOP was measured just before LTP and repeatedly during the 60-month study period. Our previous report on 12 months follow-up data revealed no effect of LTP in eyes having an IOP <15 mmHg before the laser treatment. Results: Before LTP, the mean IOP +/- standard deviation in all 152 study-eyes of 122 multi-treated patients was 14.0 +/- 3.5 mmHg. Three eyes of three deceased patients were lost to follow-up during the 60 months. After exclusion of eyes that received increased therapy during follow-up, the IOP was significantly reduced at all visits up to 48 months in eyes with pre-LTP IOP >= 15 mmHg; 2.6 +/- 3.1 mmHg at 1 month and 1.7 +/- 2.8 mmHg at 48 months, n = 56 and 48, respectively. No significant IOP reduction was seen in eyes with pre-LTP IOP <15 mmHg. Seven eyes, i.e., <13%, with pre-LTP IOP >= 15 mmHg at baseline had required increased IOP-lowering therapy at 48 months. Conclusion: LTP performed in multi-treated patients may provide a useful IOP reduction that is maintained over several years. This was true on a group level when the initial IOP was >= 15 mmHg, but if the pre-laser IOP was lower than that, chances of LTP success were small., Originally included in thesis in manuscript form.

Purpose: The aim of the study was to determine the perimetric rate of glaucoma progression in the ongoing Glaucoma Intensive Treatment Study (GITS) after 3 years of follow-up. Design: This is a randomized, two-centre, prospective open-labelled treatment trial for open-angle glaucoma (OAG). Participants The participants of this study were treatment-naive patients with newly diagnosed OAG, aged 46-78 years, with early to moderate glaucomatous visual field loss scheduled to be followed for 5 years within the study. Methods: Patients were randomized to initial treatment with either topical monotherapy or with an intensive approach using drugs from three different classes, plus 360 degrees laser trabeculoplasty. Changes in treatment were allowed. Standard automated perimetry and tonometry were performed and side-effects documented. All results are presented using intention-to-treat analysis. Results: A total of 242 patients were randomized. After 3 years of follow-up, eight patients were lost to follow-up, six of whom were deceased. The median untreated baseline intraocular pressure (IOP) was 24 mmHg in both arms. The median IOP was almost constant over the 3 years of follow-up: approximate to 17 mmHg in the mono-arm and approximate to 14 mmHg in the multi-treatment arm. Treatment was intensified in 42% of the mono-treated patients and in 7% of the multi-treated patients. Treatment was reduced in 13% of the multi-treated patients. The median perimetric rate of progression was -0.5%/year in the mono-treated group and -0.1%/year in the multi-treated group (p = 0.03). Conclusion: The rate of disease progression was significantly slower in the multi-treated patients than in the mono-treated patients. Further follow-up will show whether this difference is sustained over time.

Purpose: To evaluate the intraocular pressure (IOP)‐lowering effect of laser trabeculoplasty (LTP) in eyes which IOP had been substantially reduced by intensive topical treatment for one week. Methods: Patients with newly diagnosed open‐angle glaucoma were randomized to treatment with three IOP‐lowering substances. One week later, 360° argon or selective LTP was performed. IOP was measured before LTP and at one‐, three‐, six‐ and 12‐month post‐LTP. The patients were part of the Glaucoma Intensive Treatment Study (GITS). Results: Mean IOP (± SD) in 152 eyes of 122 patients was 14.0 (± 3.5) mmHg just before LTP. For every mmHg higher IOP prior to LTP, the IOP was reduced by an additional 0.6 mmHg at 12 months. The IOP was significantly reduced at all follow‐up visits from −2.6 (± 3.1) mmHg at one month to −2.1 (± 3.8) mmHg at 12 months in eyes with pre‐LTP IOP ≥ 15 mmHg, while no significant IOP reduction was seen in eyes with pre‐LTP IOP < 15 mmHg. Older age, argon LTP and male sex were associated with larger IOP reduction after 12 months, whereas presence of exfoliation syndrome was associated with a smaller IOP reduction. No severe complications were reported. Conclusion: Success of LTP was highly dependent on the IOP level prior to LTP treatment. A sustained significant IOP reduction was seen in eyes with pre‐LTP IOP ≥ 15 mmHg whereas no such effect was seen in eyes with pre‐LTP IOP < 15 mmHg. Thus, LTP can be considered in eyes with multi‐treatment when target pressure of < 15 mmHg is not achieved.

Purpose: To study newly diagnosed glaucoma patients given mono‐ or multi‐therapy regarding differences in initial intraocular pressure (IOP) reduction, target IOP levels reached and influence of untreated baseline IOP on IOP reduction. Methods: Patients newly diagnosed with manifest primary open‐angle glaucoma and included in the Glaucoma Intensive Treatment Study (GITS) were randomized to immediate intensive treatment with any of three different IOP‐lowering substances supplied in two bottles plus 360° laser trabeculoplasty or to conventional stepwise treatment starting with a single‐drug. Intraocular pressure reduction was analysed 1 month after initiation of treatment. Results: One hundred eighteen patients (143 eyes) received mono‐therapy and 122 patients (152 eyes) multi‐therapy. Median baseline IOP was 24.0 (min: 9.7, max: 56.0) mmHg in mono‐therapy eyes and 24.0 (min: 12.3, max: 48.5) mmHg in multi‐therapy eyes (p = 0.56). After 1 month in the two groups, respectively, values for median IOP reduction were 6.3 (range: −5.3–31.0) and 11.0 (range: 0.7–34.5) mmHg, and for mean relative decline 26.8 (range: −32.0–55.4) and 46.0 (range: 4.6–81.6) % (p = 0.000). A larger proportion of the multi‐therapy patients reached each target IOP level (p = 0.000). The higher the baseline IOP, the larger the observed pressure reduction, considering both absolute and relative figures. The effect was more pronounced in eyes with multi‐therapy than in those with mono‐therapy (p = 0.000). For every mmHg higher IOP at baseline, the IOP was reduced by an additional 0.56 (mono‐therapy) or 0.84 (multi‐therapy) mmHg. Conclusion: Intensive treatment led to considerably greater IOP reduction than mono‐therapy. Among patients with IOP ≥30 mmHg at diagnosis an IOP of <16 was reached in 2/3 of those with multi‐therapy but in none with mono‐therapy. The IOP reduction was highly dependent on the untreated IOP level.

Purpose: The primary objective of the ongoing Glaucoma Intensive Treatment Study (GITS) is to evaluate the effectiveness of immediate intensive treatment in comparison with the commonly recommended stepped regimen on the predicted visual field. The two treatment arms are also being compared regarding quality of life (QoL), intraocular pressure (IOP) reduction, frequency of reported side‐effects, adverse events and adherence to prescribed treatment. Design: A randomized, two‐centre, prospective open‐labelled treatment trial for open‐angle glaucoma. Participants: Individuals aged 40–78 years with previously untreated and newly diagnosed glaucoma with early to moderate visual field loss were eligible. Methods: Patients were randomized to initial treatment either using drug monotherapy in accordance with common glaucoma guidelines or using a more intensive approach including eyedrops containing drugs from three different classes combined with 360° laser trabeculoplasty. The patients are to be followed for 5 years at visits including standard automated perimetry, optical coherence tomography (OPT) and tonometry. Change of treatment is allowed and decided upon jointly with the patient as in conventional glaucoma management.Main outcome: The estimated predicted preserved visual field and QoL at end of expected lifetime. Results: A total of 242 patients, 45% females, mean age 68 years, were randomized. The median untreated IOP was 24 mm Hg, and the median visual field index (VFI), indicating the percentage of a full field, was 92%. Conclusion: Glaucoma Intensive Treatment Study is a clinical trial in which two groups of patients randomized to different initial intensities of IOP‐reducing treatment are being compared with regard to rate of visual field progression and prediction of serious glaucomatous visual field loss at estimated at end of life.

Background: The prevalence of blindness and visual impairment from glaucoma is influenced by the criteria used to define these entities, which differ between countries and regions, as well as among published reports. The objective of the present study was to ascertain the extent to which different criteria of blindness and visual impairment influence estimates of the number of patients classified as blind or visually impaired by glaucoma in a clinic-based population. Methods: We conducted a retrospective chart review of 914 patients with open-angle glaucoma to compare numbers of patients identified as visually impaired with and without considering visual field status. We also compared proportions classified using World Health Organisation (WHO) and United States (US) blindness criteria, and applying a new US Social Security Administration (SSA) disability criterion: perimetric mean deviation (MD) <= -22 dB. Results: Forty patients (4.4%) were bilaterally blind from glaucoma by the WHO criteria. Fifty-two (5.7%) were blind by the the US criterion. Assessing only visual acuity, 14 (1.5%) patients were blind by the WHO criteria and 24 (2.6%) by the US definition. Eighty-five (9.3%) met the US SSA disability criterion. Among those, 52 were impaired also by the WHO definition. No patients impaired according to the WHO criteria had MD values better than -22 dB. Conclusions: Excluding visual field status will seriously underestimate the prevalence of glaucoma blindness. In our patient population, 30% more patients were classified as blind by the US than by the WHO definition. Also, 60% more were identified as visually impaired by the US SSA criterion than by the WHO criteria. Visual field assessment is vital to determine visual impairment caused by glaucoma.