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Abstract #8093 Published in IGR 4-3
Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial
Heijl A; Leske MC; Bengtsson B; Hyman L; Hussein MArchives of Ophthalmology 2002; 120: 1268-1279
OBJECTIVE: To provide the results of the Early Manifest Glaucoma Trial, which compared the effect of immediately lowering the intraocular pressure (IOP), versus no treatment or later treatment, on the progression of newly detected open-angle glaucoma. DESIGN: Randomized clinical trial. PARTICIPANTS: Two hundred and fifty-five patients aged 50-80 years (median, 68 years) with early glaucoma, visual field defects (median mean deviation, -4 dB), and a median IOP of 20 mmHg, mainly identified through a population screening. Patients with an IOP greater than 30 mmHg or advanced visual field loss were ineligible. INTERVENTIONS: Patients were randomized to either laser trabeculoplasty plus topical betaxolol hydrochloride (n = 129) or no initial treatment (n = 126). Study visits included Humphrey Full Threshold 30-2 visual field tests and tonometry every three months, and optic disc photography every six months. Decisions regarding treatment were made jointly with the patient when progression occurred and thereafter. MAIN OUTCOME MEASURES: Glaucoma progression was defined by specific visual field and optic disc outcomes. Criteria for perimetric progression were computer based and defined as the same three or more test point locations showing significant deterioration from baseline in glaucoma change probability maps from three consecutive tests. Optic disc progression was determined by masked graders using flicker chronoscopy plus side-by-side photogradings. RESULTS: After a median follow-up period of six years (range, 51-102 months), retention was excellent, with only six patients lost to follow-up for reasons other than death. On average, treatment reduced the IOP by 5.1 mmHg or 25%, a reduction maintained throughout follow-up. Progression was less frequent in the treatment group (58/129; 45%) than in controls (78/126; 62%) (p = 0.007) and occurred significantly later in treated patients. Treatment effects were also evident when stratifying patients by median IOP, mean deviation, and age as well as exfoliation status. Although patients reported few systemic or ocular conditions, increases in clinical nuclear lens opacity gradings were associated with treatment (p = 0.002). CONCLUSIONS: The Early Manifest Glaucoma Trial is the first adequately powered randomized trial with an untreated control arm to evaluate the effects of IOP reduction in patients with open-angle glaucoma who have elevated and normal IOP. Its intent-to-treat analysis showed considerable beneficial effects of treatment that significantly delayed progression. Whereas progression varied across patient categories, treatment effects were present in both older and younger patients, high- and normal-tension glaucoma, and eyes with less and greater visual field loss.
A. Heijl, MD, Department of Ophthalmology, Malmo University Hospital, SE-20502 Malmo, Sweden. anders.heijl@oftal.mas.lu.se
Classification:
11.1 General management, indication (Part of: 11 Medical treatment)
