Abstract
Purpose: :
We studied the effects on vision and IOP of simultaneous cataract extraction and initial surgical versus medical therapy for glaucoma in Indian patients.
Methods: :
The INGOT Study at Aravind Eye Hospital, India, was a randomized trial of surgery versus medicines in newly diagnosed glaucoma patients. Patients were divided into those with and without visually significant cataract. However, among patients randomized to surgery, 54% refused treatment or received medications instead. We therefore present observational data on baseline and change in logMAR vision and IOP at 6 months among four groups: mitomycin trabeculectomy (T), combined trabeculectomy/mitomycin and phacoemulsification (TC), medical therapy (M) and medical therapy plus cataract surgery (MC).
Results: :
Among 398 persons enrolled, 317 (80.0%) received treatment and had >= 1 follow-up visit (209 = 66% had >= 6 months follow-up). These subjects had a mean age of 59.1 +/- 10.0 years, 26.3% were female, and treatments actually received were: T (n=44), TC (n=85), M (n=142), MC (n=46). Decline in IOP (adjusted for baseline IOP, age and gender) was significantly greater for T (baseline 31.1+/-8.8, follow-up 14.8 +/- 4.5, change -16.3 +/- 8.4 mmHg) compared to M (baseline 26.6 +/- 8.3, follow-up 19.6 +/- 6.5, change -7.0 +/- 7.8 mmHg, p < 0.0001), while decline in IOP did not differ significantly between TC and MC (P = 0.19). Decline in IOP was significantly greater for T compared to TC (baseline 24.1+/-8.8, follow-up 15.8+/-5.5, change -8.3+/-8.6mmHg, P=0.009), while decline in IOP did not differ between M (-7.0+/-7.8 mmHg) and MC (-6.3+/-5.5 mmHg, P=0.16). Improvement in post-operative presenting vision (adjusted for age, gender and baseline acuity) was significantly (p = 0.032) better for MC as compare to M, while receiving cataract surgery was unassociated with greater improvement in vision (p = 0.68) for TC compared to T.
Conclusions: :
Surgery achieved significantly greater IOP reduction, except with concurrent cataract extraction. Simultaneous cataract surgery resulted in reduced effectiveness of surgical but not medical therapy. Cataract surgery was associated with greater improvement in vision among patients receiving medical but not surgical therapy.
Clinical Trial: :
ISRCTN52778666
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cataract