Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Early trabeculectomy versus conventional management in primary open angle glaucoma. Long-term functional outcome after early surgery compared with laser and medicine in open-angle glaucoma. 5-Fluorouracil in initial trabeculectomy. A prospective, randomized, multicenter study. 5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial. The immediate pressure response to primary laser trabeculoplasty--a comparison of one- and two-stage treatment. Early Manifest Glaucoma Trial: design and baseline data. Primary argon laser trabeculoplasty vs pilocarpine. IV. Long-term effects on optic nerve head.
To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS).
                Randomized clinical trial.
                Six hundred seven newly diagnosed glaucoma patients.
                In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models.
                VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied.
                On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group.
                Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma. To compare the long-term results of trabeculectomy and Ahmed glaucoma valve implant in the initial surgical management of primary open- and closed-angle glaucoma.
                Randomized controlled clinical trial.
                One eye each of consecutive patients with primary glaucoma and without prior intraocular surgery was randomized to receive either trabeculectomy or the Ahmed implant. Large university-affiliated eye hospital in Columbo, Sri Lanka.
                Of 123 patients, 64 were randomized to trabeculectomy and 59 to the Ahmed implant. With a mean follow-up of 31 months, the trabeculectomy group had statistically lower intraocular pressures (IOP) during the first postoperative year. After the first year, the IOPs were comparable. No statistically significant differences between groups were noted for postoperative visual acuity, visual field, anterior chamber depth, and short-term or long-term complications. Adjunctive medication requirement was comparable for both groups. The cumulative probabilities of success (IOP <21 mm Hg and at least 15% reduction in IOP from preoperative levels) at the final follow-up period (months, 41-52) were 68.1% for trabeculectomy and 69.8% for Ahmed implant (P =.86).
                Lower IOPs were noted for the trabeculectomy group during the first year. With longer follow-up, the IOPs and the cumulative probabilities of success were comparable between the two groups. The results of a randomised, prospective, multicentre trial of the management of primary open angle glaucoma are presented at up to five years' follow up. Previously undiagnosed cases were selected with intraocular pressure of 26 mmHg or more on two occasions together with field loss characteristic of glaucoma. Analysis was performed on one eye selected at random from each of 99 patients. Conventional medical treatment followed in unsuccessful cases by trabeculectomy (group A) was compared with trabeculectomy at diagnosis followed when necessary by supplementary medical therapy (group B). The life expectancy of these glaucoma patients was found to be similar to that for the local population matched for age and sex. In group A after four years trabeculectomy had been performed in 53% of eyes because medical management had failed to control the disease. The rate of operation was lower in those patients with intraocular pressure less than 31 mmHg and mild relative field loss (17% at three years) than in those with intraocular pressure greater than 30 mmHg and dense scotomas (75% at three years). Early surgery provided much more stable control with fewer changes in treatment than in group A. The group mean intraocular pressure after trabeculectomy was 15.0 mmHg irrespective of the time of operation, and this was significantly lower than the intraocular pressure in those cases thought to be controlled on medical therapy alone at the end of the first year (20.8 mmHg). Early operation provided significantly better protection of visual field, and the extra loss of visual field with delayed operation occurred in the preoperative period. Changes in visual fields were not related to the use of miotics. There was no significant difference in the final visual acuity in the two groups, but six cases in group A lost central fixation because of progressive loss of visual field, and there were no such cases in group B. Cataract occurred in approximately 10% of cases in both groups, but in group A this happened with only half the number of operations and at a shorter postoperative follow-up than in group B. It appears that in cases of primary open angle glaucoma of this severity the risk of delaying operation are significantly greater than those of performing trabeculectomy as the primary treatment. This randomly allocated prospective clinical study was designed to assess the relative efficacy of laser trabeculoplasty, medical therapy, and trabeculectomy used as the primary treatment in open-angle glaucoma, with particular regard to the level of intraocular pressure control and the amount of visual field decay. No patient had received any antiglaucoma treatment before entry into the trial.
                One hundred sixty-eight patients were entered into the trial and randomly allocated into one of the three treatment groups--laser, medicine, or surgery. Follow-up was for a minimum of 5 years. The patients were monitored in the standard way, including intraocular pressure estimations and visual field tests (initially using the Friedmann analyzer and later including Humphrey automated perimetry).
                Despite similar initial composition of the three treatment groups, primary surgery resulted in the lowest mean intraocular pressures. The perimeter Friedmann visual fields were shown to have deteriorated in patients in the medicine-treated group and to a lesser extent in patients in the laser-treated group, but not in patients in the surgery-treated group. Multivariate linear regression analysis showed that the difference in field changes between laser and surgical treatments could be explained entirely by the difference between the intraocular pressure values at 6 months between the two groups. The same was not true for the medicine-treated group.
                Primary trabeculectomy appears to have the desired effect in preserving visual function in patients with high-tension glaucoma. This may be related to laser treatment might be expected to have the same effect. Postoperative subconjunctival 5-fluorouracil (5-FU) injections increase the success of filtration surgery in eyes with prior filtration failure or cataract removal and in eyes with secondary glaucoma. The authors evaluate the safety and benefit of adjunctive 5-FU in eyes undergoing initial trabeculectomy.
                Patients with phakic, uncontrolled, open-angle glaucoma who were undergoing initial trabeculectomy were prospectively assigned to the 5-FU group on the first postoperative day. Patients in this group received five 5-mg injections during 2 weeks after surgery. Patients in the control group received no injections.
                Preoperative intraocular pressure (IOP) and number of antiglaucoma medications were similar in the 5-FU (n = 32) and control (n = 30) groups. Transient superficial punctate keratopathy was the only postoperative complication that occurred more frequently (P < 0.05) in the 5-FU (14 eyes) than in the control eyes (3 eyes). Patients were followed for a minimum of 1 year or until a study endpoint was reached: IOP of 21 mmHg or greater with maximum medical therapy (2 5-FU eyes and 8 control eyes; P < 0.03) or cataract removal after filtration (5 treated and 3 control eyes). At last follow-up (mean, > 20 months), IOP and the number of antiglaucoma medications were significantly lower (P < 0.02) in the 5-FU eyes (IOP, 12.0 +/- 1.3 mmHg; medications, 0.2 +/- 0.1) than in the control eyes (IOP, 16.8 +/- 1.3 mmHg; medications, 0.8 +/- 0.2). Intraocular pressure was 20 mmHg or lower in 94% of 5-FU eyes and in 73% of control eyes (P < 0.03) and 16 mmHg or lower in 84% of 5-FU eyes and in 57% of control eyes (P < 0.02).
                Adjunctive 5-fluorouracil increases the rate of success, decreases the level of postoperative IOP, and reduces the need for postoperative antiglaucoma medication in eyes with open-angle glaucoma undergoing initial trabeculectomy. To test the effect of postoperative subconjunctival 5-fluorouracil (5-FU) on the pressure outcome in combined procedure (limbus-based trabeculectomy + clear-cornea phacoemulsification).
                Prospective randomized, controlled clinical trial; n = 24 eyes (24 patients) with concurrent open-angle glaucoma and cataract; 12 eyes per treatment group; sample size adjusted for a minimal expected difference in the event rate between the 2 treatment groups = 50%, control rate = 20%; type I error = 0.05; power = 95%. Uncomplicated limbus-based trabeculectomy + uncomplicated clear-cornea phacoemulsification + posterior chamber intraocular lens. The 5-FU group = five subconjunctival injections of 5 mg 5-FU, starting from day 8 after surgery, one injection per week. Control group = no injections. The groups were matched for age, preoperative intraocular pressure (IOP), duration of preoperative antiglaucoma treatment, preoperative pilocarpine and adrenergics, preoperative laser trabeculoplasty, and beta-blockers in the fellow eye. The IOP less than or equal to 15 mmHg without treatment 1 year after surgery (IOP = average of the two highest values measured in the diurnal curve, 8 AM to 6 PM, one reading every 2 hours).
                Each patient completed a 1-year follow-up. Ten of 12 eyes of the 5-FU group showed an IOP less than or equal to 15 mmHg at the end of follow-up versus 1 of 12 eyes in the control group (Fisher's exact test, P = 0.00064). The IOP range was 10 to 17 mmHg in the 5-FU group and 14 to 22 mmHg in the control group.
                Postoperative 5-FU may improve the 1-year success rate of trabeculectomy combined with clear-cornea phacoemulsification. The immediate pressure response to primary LTP was studied prospectively in 40 eyes randomised to one- and two-stage treatment in 360 degrees of the trabecular meshwork. There were 26 eyes with glaucoma capsulare and 14 with glaucoma simplex. Mean prelaser IOP was 32.8 mmHg in the former, and 35.5 mmHg in the latter group. The frequency and magnitude of postlaser pressure increase were the same in both groups when taking into consideration the pressure spikes in both 180 degrees sessions. The pressure increase was higher than in earlier reports on LTP in presurgical glaucoma patients on maximum medication. Almost all IOP elevations appeared during the first 2 h following laser treatment. The results were the same in both groups 6 months after LTP. The Early Manifest Glaucoma Trial (EMGT) will evaluate the effectiveness of reducing intraocular pressure (IOP) in early, previously untreated open-angle glaucoma. Its secondary aims are to explore factors related to glaucoma progression and to study the natural history of the disease. This article describes the EMGT design and presents baseline data.
                Randomized, clinical trial.
                Newly diagnosed patients 50 to 80 years of age with early glaucomatous visual field defects were mainly identified from a population-based screening of more than 44,000 residents of Malmö and Helsingborg, Sweden. Exclusion criteria were advanced visual field loss; mean IOP greater than 30 mmHg or any IOP greater than 35 mmHg; visual acuity less than 0.5; and inability to complete follow-up protocols.
                After informed consent, patients were randomized to treatment or no initial treatment with close follow-up. Treated patients had laser trabeculoplasty and started receiving topical betaxolol twice daily in eligible eyes. Follow-up visits include computerized perimetry and tonometry every 3 months and fundus photography every 6 months. Decisions to change or begin treatment are made jointly with the patient when EMGT progression occurs and also later if clinically needed.
                The EMGT progression is defined by sustained increases of visual field loss in three consecutive C30-2 Humphrey tests, as determined from computer-based analyses, or by optic disc changes, as determined from flicker chronoscopy and side-by-side comparisons of fundus photographs performed by masked, independent graders.
                A total of 255 patients were randomized between 1993 and 1997 and will be followed for at least 4 years. All had generally good health status; mean age was 68.1 years, and 66% were women. At baseline, mean IOP was 20.6 mmHg and 80% of eyes had IOP less than 25 mmHg.
                The Early Manifest Glaucoma Trial is the first large randomized, clinical trial to evaluate the role of immediate pressure reduction, as compared to no initial reduction, in patients with early glaucoma and normal or moderately elevated IOP. Its results will have implications for: (1) the clinical management of glaucoma; (2) understanding the role of IOP and the natural history of glaucoma; and (3) evaluating the rationale for glaucoma screening. In a prospective, randomized study on primary argon laser trabeculoplasty vs piloparpine in 82 newly detected open-angle glaucomas the progress of optic nerve head damage is presented. In 70 patients reliable stereo photographs could be analysed. In the laser treated group a progression of glaucoma damage after 24 months was seen in 6/37 eyes (16%) and in the pilocarpine-treated group 16/33 (49%) (p = 0.0048). There was a statistically significant favourable outcome if intraocular pressure was regulated in terms of peak and range of pressure, but not average pressure. This was even more pronounced in capsular glaucoma, but not significant for simple glaucoma. Pilocarpine increased the risk for further damage to the optic nerve head 6.4 times compared to laser trabeculoplasty. Thus, laser is recommended as the primary therapy in high tension glaucoma, especially in capsular glaucoma.
Primary surgery lowers IOP more than primary medication but is associated with more eye discomfort. One trial suggests that visual field restriction at five years is not significantly different whether initial treatment is medication or trabeculectomy. There is some evidence from two small trials in more severe OAG, that initial medication (pilocarpine, now rarely used as first line medication) is associated with more glaucoma progression than surgery. Beyond five years, there is no evidence of a difference in the need for cataract surgery according to initial treatment.
The clinical and cost-effectiveness of contemporary medication (prostaglandin analogues, alpha2-agonists and topical carbonic anhydrase inhibitors) compared with primary surgery is not known.
Further RCTs of current medical treatments compared with surgery are required, particularly for people with severe glaucoma and in black ethnic groups. Outcomes should include those reported by patients. Economic evaluations are required to inform treatment policy.