DO ANTERIOR-CHAMBER IOLS HAVE A ROLE IN DEVELOPING-COUNTRIES - RESULTS OF A CLINICAL-TRIAL IN NEPAL

There are estimated to be 20 million people blinded by cataracts, 80-9 0% of whom live in rural areas of developing countries where expert su rgical resources are scarce. The majority of all cataract operations a re still intracapsular extractions (ICCE). Aphakic correction using sp ectacles is problematical in developing countries. This study was unde rtaken to evaluate the safety of multiflex open loop anterior chamber intraocular lenses (AC IOLs). Methods: A total of 2000 people attendin g Lahan Eye Hospital, South-east Nepal, with bilateral cataract were r andomly allocated to receive in their first eye either ICCE with AC 10 1 (AC IOL group) or ICCE with aphakic correction (control group). All operations were performed by two ophthalmologists using a standardized technology and 4.5 x operating loupe magnification. Functional and be st corrected vision was recorded. The primary outcome measure was poor vision after surgery, which was defined as a visual acuity of less th an 6/60 at 1 year follow-up (WHO definition for severe visual impairme nt and blindness). Findings: The median time needed to perform ICCE wa s 4.1 min and to perform ICCE with AC IOL 6 min. Of all study patients 91% were examined after 1 year. Five percent of the BC IOL group and 5.4% of the control group had a functional visual acuity of less than 6/60. Causes of reduced vision in the AC IOL group versus the control group were: correctable refractive error (22 vs 29), uveitis/secondary glaucoma (13 vs 2), endophthalmitis (4 vs 7), pre-existing eye diseas es (4 vs 5), retinal detachment (0 vs 4), and corneal decompensation ( 0 vs 1). Of the control group, 24 patients were found to be functional ly blind in the operated eye (vision < 3/60) because they did not wear their aphakic spectacles. Normal vision (WHO definition: greater than or equal to 6/18) was achieved best corrected in 89.9% of the AC IOL group and 93.2% of the control group. Analysis of additional long-term follow-ups (2-5 years post-operatively) has not yet been completed. I nterpretation: This study provides evidence that in developing countri es well-manufactured multiflex open loop AC IOLs can be implanted safe ly by experienced ophthalmologists after routine ICCE, avoiding the di sadvantages of aphakic spectacle correction.