The South Asian cataract management study: Complications, vision outcomes,and corneal endothelial cell loss in a randomized multicenter clinical trial comparing intracapsular cataract extraction with and without anterior chamber intraocular lens implantation

Objective: To determine clinical outcomes of primary intracapsular cataract surgery with and without implantation of anterior chamber lenses. Design: A multicenter randomized clinical trial. Participants: One thousand two hundred twenty-nine male and female patients 40-75 years of age with senile cataract, Methods: Study patients were recruited from screening eye camps and outpati ent clinics. Randomization to the two treatment groups was performed after screening for predetermined inclusion and exclusion criteria. Demographics, visual acuity, intraocular pressures, and corneal endothelial cell data we re recorded before surgery and at 6 weeks, 12 months, and 24 months after s urgery. Monitoring of the study was secured by a standardized image documen tation procedure on all patients using the IMAGEnet digital imaging system. Analysis of corneal endothelial cell images was performed with the Cell Sof t software (Topcon Corporation, Japan). Main Outcome Measures: Visual acuity and central corneal endothelial cell l oss. Results: The patients were randomized to intraocular lens (IOL; n = 616) an d no IOL (n = 613) implantation. Surgical complications were reported in 17 7 (14.4%) patients (IOL = 14.8%; no IOL = 14.0%). The most frequent complic ation observed was vitreous loss which occurred in 10.3% of eyes (IOL = 11. 2%; no IOL = 9.5%). At the final examination (2 years after surgery), 88% o f the operated eyes had a best corrected vision of 6/18 or better (IOL = 88 .8%; no IOL = 86.6%). Analysis of corneal endothelial cell data showed a sm all but significantly greater cell loss 6 weeks after surgery in eyes with IOL compared with those without IOL, but no overall difference was found be tween the treatment groups in the long term follow-up. Conclusions: The findings indicate that there is a rationale for the use of anterior chamber intraocular lenses in primary intracapsular cataract surg ery. (C) 2000 by the American Academy of Ophthalmology.