The Madurai Intraocular Len tudy I: A Randomized Clinical Trial Comparing Complication and Viion Outcome of Intracapular Cataract Extraction and Extracapular Cataract Extraction With Poterior Chamber Intraocular Len

Purpoe: The Madurai Intraocular Len tudy (MIOL) wa deigned to compare afety, efficacy, and quality of life outcome after either intracapular cataract extraction with aphakic glae (ICCE-AG) or extracapular cataract extraction with poterior chamber intraocular len (ECCE/ PC-IOL). Method: The Madurai Intraocular Len tudy wa a nonmaked randomized controlled clinical trial conducted at a ingle hopital. Thirty-four hundred patient with age-related cataract and having a bet-corrected viual acuity le than or equal to 20/120 in the better eye were randomly aigned to either of the two cataract operative procedure. The main clinical outcome were afety (complication rate) and efficacy (betcorrected viual acuity at 1 year equal to or better than 20/40. In addition, a ubet of 1,700 trial participant received quetionnaire before urgery, at 6 month after urgery, and at 1 year after urgery to meaure viual functioning and viionrelated quality of life. Reult: Detail of tudy deign, tudy organization, clinical and quality of life outcome variable, ample ize calculation, patient eligibility criteria and recruitment, randomization and making, participant flow, adherence to followup, quality aurance, and tatitical method are preented. Concluion: The Madurai Intraocular Len tudy ha ufficient power to detect clinically ignificant difference between the treatment option. There were no tatitically ignificant difference between the two treatment group for any of the major tudy variable at baeline. A high level of quality aurance wa maintained throughout the October 1993 to June 1996 tudy period. The reult hould be applicable to all etting where the requiite expertie and reource are preent.