Randomised controlled trial of anterior-chamber intraocular lenses

被引:48
作者
Hennig, A
Evans, JR
Pradhan, D
Johnson, GJ
Pokhrel, RP
Gregson, RMC
Hayes, R
Wormald, RL
Foster, A
机构
[1] MOORFIELDS EYE HOSP, INST OPHTHALMOL, DEPT OPHTHALM EPIDEMIOL, LONDON EC1V 2PD, ENGLAND
[2] LAHAN EYE HOSP, LAHAN, NEPAL
[3] INST OPHTHALMOL, DEPT PREVENT OPHTHALMOL, LONDON, ENGLAND
[4] NEPAL NETRA JYOTI SINGH, Kathmandu, NEPAL
[5] UNIV NOTTINGHAM HOSP, QUEENS MED CTR, NOTTINGHAM NG7 2UH, ENGLAND
[6] UNIV LONDON LONDON SCH HYG & TROP MED, LONDON WC1E 7HT, ENGLAND
关键词
D O I
10.1016/S0140-6736(96)11043-6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background There are an estimated 16 million people blind in both eyes with cataracts. Most live in rural areas of developing countries where surgical resources are scarce. There is no consensus on the most appropriate type of intraocular lens in situations where high-volume low-cost surgery is required, This study was undertaken to evaluate the safety of multiflex open-loop anterior-chamber lenses (ACIOLs). Methods 2000 people attending Lahan Eye Hospital, southern Nepal, with bilateral cataracts reducing vision to 6/36 or less were randomly allocated to receive standard surgery-intracapsular extraction (ICCE) with aphakic correction-or ICCE with an ACIOL in their first operated eye. The primary outcome was a visual acuity of less than 6/60 in the operated eye at 1 year follow-up. Visual acuity was measured for 91% of the cohort at 1 year, The sample size was estimated to detect a doubling in poor visual outcome from an estimated rate of 4% in the standard surgery (control) group. Findings The median (range) time taken to do the surgery was 6.0 (3.0-17.2) min for the ACIOL group and 4.1 (2.4-10.3) min for the control group. 1 year after surgery, 5.0% of the ACIOL group and 5.4% of controls had functional Vision less than 6/60 (OR 0.93 [0.60-1.43], p=0.71). The causes of poor vision in the ACIOL and control groups were: correctable refractive error (22 and 29), uveitis/secondary glaucoma (13 and two), endophthalmitis (four and seven), pre-existing eye disease (four and five), retinal detachment (none and four), cystoid macular oedema (two and none), corneal ulcer (one and one), and corneal decompensation (none and one). Interpretation This study provides evidence that, in rural areas of developing countries, multiflex open-loop ACIOLs can be implanted safely by experienced ophthalmologists after routine ICCE, avoiding the disadvantages of aphakic spectacle correction. Further follow-up is planned.
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收藏
页码:1129 / 1133
页数:5
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