Clinical Evaluation of Morcher Artificial Iris Diaphragms
Keywords
Abstract
Description
Aniridia is a condition in which the iris, the colored portion of the eye, is either partially or completely absent. The iris is responsible for regulating the amount of light entering the eye by adjusting the size of the pupil.
Aniridia can either be a congenital condition, often a genetically-based abnormality affecting the formation of the iris, or it can be acquired by blunt trauma with or without rupture, penetrating trauma, or severe intraocular inflammation.
Aniridia can also vary in the level of severity. A mild case might involve a thinner iris or iris remnant with a normal pupil. A severe case might involve complete absence of the iris or impairment of the muscles responsible for adjusting pupil size.
Iris defects can occur without the loss of stromal tissue as well. In some cases, the iris pigment epithelium is missing. In other cases, holes are present in the iris or the pupil is chronically enlarged or mydriatic.
People who suffer from iris defects also commonly suffer from other eye conditions. Common comorbidities include glaucoma, cataract, and nystagmus. Other structures in the eye are often affected, including the cornea, crystalline lens, zonules, and retina. Iris defects can cause severe visual disability if untreated.
Common treatments for iris defects include the use of colored or tinted glasses or contact lenses to reduce the amount of light entering the eye.
In this trial, several Morcher iris diaphragms are being evaluated as a potential treatment to improve the symptoms associated with aniridia and other iris defects. Morcher iris diaphragms are manufactured in Germany by Morcher GmbH [website: http:// www.morcher.com]. These devices have been utilized in Europe to treat aniridic patients for over 40 years. Additionally, these devices hold the European CE mark of conformity.
When a patient is implanted with a Morcher iris device, surgery always involves additional standard of care surgical procedures. Typically, a device is implanted during cataract surgery along with an intraocular lens (IOL). Morcher devices can also be implanted during an IOL exchange with or without an anterior vitrectomy. All implantation procedures take place in an operating room under local or general anesthesia. In some cases, a Morcher iris reconstruction lens containing both an artificial iris and a lens is implanted. Also, depending on the condition of the eye, the lens and iris device may need to be sutured to the sclera, the white portion of the eye.
All patients undergoing surgery are prescribed 2 different eye drops, an antibiotic and a corticosteroid. These medications are used for up to 6 weeks following implantation of the device. There are 5 postoperative follow-up visits that each patient must complete. Visits occur at specific intervals over the course of a 1-year period. At each visit, standard of care procedures are performed and, at certain time points during the follow-up interval, digital photos and endothelial cell counts are obtained. In instances where both eyes are implanted, surgery for the second eye is scheduled 6 months or more later.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 12/18/2008 |
| Estimated Enrollment Submitted: | 12/18/2008 |
| First Posted: | 12/21/2008 |
| Last Update Submitted: | 04/14/2020 |
| Last Update Posted: | 04/26/2020 |
| Date of first submitted results: | 05/31/2018 |
| Date of first submitted QC results: | 05/31/2018 |
| Date of first posted results: | 06/27/2018 |
| Actual Study Start Date: | 04/08/2003 |
| Estimated Primary Completion Date: | 06/19/2014 |
| Estimated Study Completion Date: | 12/30/2021 |
Condition or disease
Intervention/treatment
Device: Morcher iris diaphragm implantation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Morcher iris diaphragm implantation This is a non-randomized, non-comparative interventional surgical series. Patients will undergo Morcher iris diaphragm implantation in their affected eye(s). After surgery, patients will complete 5 postoperative examinations. At each examination, they will be evaluated for changes in light and glare sensitivity and visual acuity. They will also be monitored for adverse reactions. | Device: Morcher iris diaphragm implantation Surgical implantation of Morcher iris device(s) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) [Preoperatively and 1 year postoperatively]
2. Change in Best Corrected Visual Acuity (Primary Safety Measure) [Preoperatively and 1 year postoperatively]
Secondary Outcome Measures
1. Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) [Preoperatively and 3 months postoperatively]
2. Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) [Preoperatively and 3 months postoperatively]
3. Change in Endothelial Cell Count (Secondary Safety Measure) [Preoperatively and 3 months postoperatively]
4. Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) [Preoperatively and 1 year postoperatively]
