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

American Journal of Ophthalmology
G NatchiarC Kupfer

Abstract

The Madurai Intraocular Lens Study (MIOLS) was designed to compare safety, efficacy, and quality of life outcomes after either intracapsular cataract extraction with aphakic glasses (ICCE-AG) or extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/ PC-IOL). The Madurai Intraocular Lens Study was a nonmasked 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 better 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 better than 20/40). In addition, a subset of 1,700 trial participants received questionnaires before surgery, at 6 months after surgery, and at 1 year after surgery to measure visual functioning and vision-related quality of life. Details of study design, study organization, clinical and quality of life outcome variables, sample size calculations, patient eligibility criteria and recruitment, randomization and masking, participant flow, adherence to follow-up, quality assurance, and statistic...Continue Reading

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Citations

Feb 24, 2001·Transactions of the American Ophthalmological Society·D J Apple
Jan 22, 2002·The British Journal of Ophthalmology·Joseph LauLeon B Ellwein
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Jan 17, 2003·Ophthalmic Epidemiology·R D ThulasirajLeon B Ellwein

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