The Madurai Intraocular Lens Study II: Clinical Outcomes

• Published in: American journal of ophthalmology 1998, Vol.125 (1), p.14-25
• Main Authors: Prajna, N. Venkatesh, Chandrakanth, K.S., Kim, R., Narendran, V., Selvakumar, Selvi, Rohini, G., Manoharan, N., Bangdiwala, Shrikant I., Ellwein, Leon B., Kupfer, Carl
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Cataract Extraction - methods; Clinical outcomes; Eyeglasses; Female; Follow-Up Studies; Humans; Incidence; India; Intraoperative Complications; Lens Implantation, Intraocular; Male; Medical sciences; Middle Aged; Postoperative Complications; Safety; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the eye and orbit; Treatment Outcome; Visual Acuity - physiology
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/S0002-9394(99)80230-X

To evaluate the safety and efficacy of extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/PC-IOL) compared with intracapsular cataract extraction with aphakic glasses (ICCE-AG). In a nonmasked randomized controlled clinical trial, 3,400 bilaterally visionimpaired patients aged 40 to 75 years with operable cataract were randomly assigned to receive either ICCE-AG or ECCE/PC-IOL at the Aravind Eye Hospital in India. The surgery was performed by one of four study surgeons. Patients were hospitalized for 5 postoperative days, with followup visits at 2, 6, and 12 months after discharge. Postsurgery evaluations were conducted by two independent study ophthalmologists. At any single postoperative follow-up time point, there were no statistically significant differences of clinical relevance between treatment groups for any complication of a serious nature except cystoid macular edema, which was more common with ICCE (4.2% vs 1.6%). In general, whether of a trivial, intermediate, or serious nature, complication rates were low at each evaluation time point. Cumulatively, the incidence of serious complications of all types throughout the 1-year study period was 14.5% for patients in the ICCE-AG group and 7.7% in the ECCE group ( P < .001). Best-corrected visual acuity of 20/40 or better at 12 months was attained by 90.7% of ICCE-AG patients and 96.3% of ECCE/PC-IOL patients ( P < .001). Although both operative procedures are safe and effective for cataract patients with bilateral impairment, ECCE/PC-IOL is superior to ICCE-AG in terms of both visual acuity restoration and safety.