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Clinical Evaluation of Morcher Artificial Iris Diaphragms

NCT00812708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-12-15

Study results available
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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.

Conditions

  • Aniridia
  • Iris; Deformity

Interventions

DEVICE

Morcher iris diaphragm implantation

Surgical implantation of Morcher iris device(s)

Sponsors & Collaborators

Principal Investigators

  • Kevin M Miller, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-09
Primary Completion
2014-06-20
Completion
2021-12-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812708 on ClinicalTrials.gov