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Anders Heijl, MD, PhD; M. Cristina
Leske, MD, MPH; Bo Bengtsson, MD, PhD; Leslie Hyman, PhD;
Boel Bengtsson, PhD; Mohamed Hussein, PhD; for the Early Manifest
Glaucoma Trial Group
Objective: To provide the results of the
Early Manifest Glaucoma Trial, which compared the effect of
immediately lowering the intraocular pressure (IOP), vs. no
treatment or later treatment, on the progression of newly
detected open-angle glaucoma.
Design: Randomized clinical trial.
Participants: Two hundred fifty-five patients
aged 50 to 80 years (median, 68 years) with early glaucoma,
visual field defects (median mean deviation, -4 dB), and a
median IOP of 20 mm Hg, mainly identified through a population
screening. Patients with an IOP greater than 30 mm Hg 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 3 months, and optic disc photography every
6 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 3 or more test point locations showing
significant deterioration from baseline in glaucoma change
probability maps from 3 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 6 years (range, 51-102 months), retention was excellent,
with only 6 patients lost to follow-up for reasons other than
death. On average, treatment reduced the IOP by 5.1 mm Hg
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 = .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 =
.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.
Arch Ophthalmol. 2002;120:1268-1279
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