THE SOUTH ASIAN CATARACT MANAGEMENT STUDY .1. THE FIRST 662 CATARACT SURGERIES - A PRELIMINARY-REPORT

Aims-The first 662 cases of a multicentre randomised clinical trial of intracapsular cataract extraction (ICCE) with and without implantatio n of a four point multiflex (Cilco Kelman Choyce Modification) anterio r chamber intraocular lens (AC IOL) were studied after 6 weeks to comp are frequency of surgical complications, short term clinical outcomes, and corneal endothelial cell loss between groups. Methods-Randomisati on was performed after screening for predetermined inclusion and exclu sion criteria. Demographics, visual acuities, intraocular pressures, a nd corneal endothelium cell data were recorded preoperatively and at 6 weeks. Details of surgical procedure, complications, and postoperativ e adverse reactions were recorded. Monitoring of the study was secured by a standardised image documentation procedure on all patients using the IMAGENET digital imaging system. Analysis of corneal endothelial cell images was done using the CELL SOFT software analysis program. Re sults-343 patients were randomised to IOL and 319 to no IOL. Twelve IO L implantations (3.5%) were aborted because of complications. A compli cation was reported in 103 (15.6%) of the surgical procedures (IOL=16 9%, no IOL=14 1%, p=0.37). The most frequent complication observed was vitreous loss followed by plain capsular rupture, unplanned ECCE, and iris dialysis. Mean corneal endothelial cell loss 6 weeks after surge ry was 17.2% (SD 13.1%) in the total study population (IOL=18.5% no IO L=16.1%, p=0.05). The postoperative complications registered until 6 w eek follow up were significantly higher in the IOL group (IOL=6 9%, no IOL=2.6%, p=0.02), mainly due to mild to moderate iritis needing prol onged use of steroids. Eighty nine per cent of the patients had a best corrected visual acuity of 6/18 or better. There was no significant d ifference in visual outcome between study groups. Conclusions-The impl antation of a multiflex AC IOL in primary ICCE surgery in the centres of this study did not increase the risk of surgical complications or s hort term sight threatening adverse clinical outcomes compared with IC CE without lens. Comparisons of corneal endothelial cell loss after 6 weeks between study groups showed no clinically significant difference . The difference in mean cell loss between groups was statistically si gnificant.