THE MADURAI INTRAOCULAR-LENS STUDY - I - A RANDOMIZED CLINICAL-TRIAL COMPARING COMPLICATIONS AND VISION OUTCOMES OF INTRACAPSULAR CATARACT-EXTRACTION AND EXTRACAPSULAR CATARACT-EXTRACTION WITH POSTERIOR CHAMBER INTRAOCULAR-LENS

PURPOSE: The Madurai Intraocular Lens Study (MIOLS) was designed to co mpare safety, efficacy, and quality of life outcomes after either intr acapsular cataract extraction with aphakic glasses (ICCE-AG) or extrac apsular cataract extraction with posterior chamber intraocular lens (E CCE/PC-IOL). METHODS: The Madurai Intraocular Lens Study was a nonmask ed randomized controlled clinical trial conducted at a single hospital . Thirty four hundred patients with age-related cataracts and having a best corrected visual acuity less than or equal to 20/120 in the bett er eye were randomly assigned to either of the two cataract operative procedures. The main clinical outcomes were safety (complication rates ) and efficacy (best-corrected visual acuity at 1 year equal to or bet ter than 20/40). In addition, a subset of 1,700 trial participants rec eived questionnaires before surgery, at 6 months after surgery, and at 1 year after surgery to measure visual functioning and vision related quality of life. RESULTS: Details of study design, study organization , clinical and quality of life outcome variables, sample size calculat ions, patient eligibility criteria and recruitment, randomization and masking, participant flow, adherence to follow-up, quality assurance, and statistical methods are presented. CONCLUSIONS: The Madurai Intrao cular Lens Study has sufficient power to detect clinically significant differences between the treatment options. There were no statisticall y significant differences between the two treatment groups for any of the major study variables at baseline. A high level of quality assuran ce was maintained throughout the October 1993 to June 1996 study perio d. The results should be applicable to all settings where the requisit e expertise and resources are present.