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N.G. Congdon, S.R. Krishnadas, A. Robin, J. Tielsch, D. Gilbert, D. Friedman, H. Quigley; A Randomized Trial of Medicines versus Surgery for the Treatment of Glaucoma in India . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3430.
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Little is known about efficacy of glaucoma treatment in the developing world. We evaluated and compared the impact of medical therapy versus surgical therapy on intra–ocular pressure (IOP) and vision–related quality of life (QOL) in India, and evaluated the possible modifying effect of concurrent cataract surgery.
Randomized trial of protocol–driven medical therapy (M) versus trabeculectomy with 5–FU or MMC (S) at Aravind Eye Hospital in India.
Among 357 persons (mean age = 59.1 +/– 10.1 years) randomized to S (178) or M (179), 115 (65%) received S and 134 (74%) received M as assigned. Only one cross–over in assigned therapy occurred; failure to receive assigned therapy in the remaining cases was due to refusal. 6–month follow–up is available currently on 73 S subjects (25 still within 6 month window) and 82 M subjects (11 in window). 109/249 (43.8%) of subjects received concurrent cataract surgery. Neither randomized nor treated subjects differed by assignment group at baseline with regard to age, gender, education, IOP, presenting VA or QOL score. With an intent–to–treat analysis excluding those without follow–up (no follow–up was available for subjects refusing treatment), 6 month reduction in IOP was significantly greater for S (37% reduction) than for M (27% reduction, p = 0.02 ). Reduction in IOP at 6 months was significantly greater with S (51%) than M (26%, p < 0.0001) among subjects without concurrent cataract surgery, but did not differ between S (28%) and M (31%, p = 0.71) among subjects receiving cataract surgery. Significant differences in QOL were not observed between S and M groups at 6 months or between baseline and 6 months for S or M, though QOL was significantly (p = 0.04) worse at 6 months for S compared to M among persons receiving concurrent cataract surgery.
Though treatment refusals were common, clinically meaningful medium–term IOP reduction appears possible with both M and S in India, with S achieving significantly greater reduction except with concurrent cataract surgery. Significant decline in QOL was not observed in association with glaucoma surgery in this setting.
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