N/A
Completed N=72
Clinical Evaluation of Morcher Artificial Iris Diaphragms
Aniridia · Iris; Deformity
Source: ClinicalTrials.gov NCT00812708 ↗
Enrolled (actual)
72
Serious AEs
9.4%
Results posted
Jun 2018
Primary outcomePrimary: Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) — 51; 12; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) |
51; 12; 1 | — |
| PRIMARY Change in Best Corrected Visual Acuity (Primary Safety Measure) |
35; 28; 1 | — |
| SECONDARY Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) |
57; 5; 2 | — |
| SECONDARY Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) |
56; 5; 3 | — |
| SECONDARY Change in Endothelial Cell Count (Secondary Safety Measure) |
17; 18 | — |
| SECONDARY Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) |
1; 63 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00812708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.