CompletedNot Applicable

Clinical Evaluation of Morcher Artificial Iris Diaphragms

United States72 participantsStarted 2003-04-09

Plain-language summary

The purpose of this study is to determine the safety and efficacy of Morcher iris diaphragms in the treatment of congenital and acquired aniridia. Morcher iris diaphragms are intraocular devices that are designed to provide an artificial pupil for patients suffering from partial or complete aniridia. These devices are constructed from clinical quality, ultraviolet light-absorbing, opaque black polymethylmethacrylate (PMMA). After surgical implantation, patients are monitored over the course of 1 year to measure any changes to visual acuity and improvements in light and glare sensitivity.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient must be 18 years old and have partial or complete aniridia. * Be willing and able to comply with all follow-up requirements. * Must have increased light and/or glare sensitivity or complete aniridia. * Patients may be phakic, aphakic, or pseudophakic. * Phakic patients will require simultaneous cataract surgery. * Aphakic patients will require secondary intraocular lens implantation. Exclusion Criteria: * The presence of any ocular condition that may cause complications from the surgical procedure * Active ocular infection or inflammation * Patients with allergies to operative and/or postoperative medications * Pregnant or lactating women * Persons who, in the determination of the investigator, are not competent to understand the procedure or the actions asked of them as research subjects

What they're measuring

Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)

Timeframe: Preoperatively and 1 year postoperatively

Change in Best Corrected Visual Acuity (Primary Safety Measure)

Timeframe: Preoperatively and 1 year postoperatively

Trial details

NCT IDNCT00812708

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06-20

Results submitted2018-06-01