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Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial.

Abstract

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.

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  • Authors+Show Affiliations

    ,

    Department of Ophthalmology, Malmö University Hospital, SE-20502 Malmö, Sweden. anders.heijl@oftal.mas.lu.se

    , , , , ,

    Source

    MeSH

    Adrenergic beta-Antagonists
    Aged
    Aged, 80 and over
    Betaxolol
    Disease Progression
    Female
    Glaucoma, Open-Angle
    Humans
    Intraocular Pressure
    Laser Therapy
    Male
    Middle Aged
    Single-Blind Method
    Trabeculectomy
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    12365904

    Citation

    Heijl, Anders, et al. "Reduction of Intraocular Pressure and Glaucoma Progression: Results From the Early Manifest Glaucoma Trial." Archives of Ophthalmology (Chicago, Ill. : 1960), vol. 120, no. 10, 2002, pp. 1268-79.
    Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10):1268-79.
    Heijl, A., Leske, M. C., Bengtsson, B., Hyman, L., Bengtsson, B., & Hussein, M. (2002). Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Archives of Ophthalmology (Chicago, Ill. : 1960), 120(10), pp. 1268-79.
    Heijl A, et al. Reduction of Intraocular Pressure and Glaucoma Progression: Results From the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10):1268-79. PubMed PMID: 12365904.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. AU - Heijl,Anders, AU - Leske,M Cristina, AU - Bengtsson,Bo, AU - Hyman,Leslie, AU - Bengtsson,Boel, AU - Hussein,Mohamed, AU - ,, PY - 2002/10/9/pubmed PY - 2002/10/31/medline PY - 2002/10/9/entrez SP - 1268 EP - 79 JF - Archives of ophthalmology (Chicago, Ill. : 1960) JO - Arch. Ophthalmol. VL - 120 IS - 10 N2 - 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. SN - 0003-9950 UR - https://www.unboundmedicine.com/medline/citation/12365904/full_citation L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/vol/120/pg/1268 DB - PRIME DP - Unbound Medicine ER -