Morcher Artificial Iris Devices to Treat Light and Glare Sensitivity in Partial or Complete Aniridia
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Compassionate Use Study of Morcher Artificial Iris Devices to Treat Light and Glare Sensitivity in Partial or Complete Aniridia|
- Postoperative changes in the best corrected non-glare and glare visual acuity, will serve as the principal endpoint measure of implant effectiveness. [ Time Frame: PreOperative and 12 Months ]An improvement of at least two-lines on the Snellen eye chart is considered a positive outcome
- Reduction in light and glare sensitivity as determined by a clinical glare test [ Time Frame: PreOperative and 12 Months ]This will be determined by measuring the patient's CDVA while shining a glare source in front of the patient's eye.
- Improvement in visual acuity under normal lighting conditions [ Time Frame: PreOperative and 3 Months ]The patient will complete a subjective survey rating the quality of their visual glare experiences for both daytime and nighttime vision
- Reduction of 10% or less of the central endothelial cell density is a safety endpoint [ Time Frame: 3 Months ]An endothelial cell count will be performed at the 3 month post-operative visit to monitor the study eye's cell density.
- Need to explant or exchange the implant in less than 25% of cases [ Time Frame: 12 Months ]Large sector iris defects may require two iris diaphragms to be implanted. In the event of complications, the implant may need to be replaced with one of different dimensions to address the patient's eye condition.
- Loss of two lines or less of best corrected visual acuity [ Time Frame: 12 Months ]A decrease in the corrected distance visual acuity at 12 Months, when compared to corrected distance visual acuity measured prior to surgery.
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||December 2030|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Morcher Iris Diaphragm Implant
This is a non-randomized, non-comparative interventional surgical series. Patient will undergo surgery to implant a Morcher artificial iris into their affected eye(s). After surgery, patients will complete five postoperative follow-up examinations. At each examination, they will be evaluated for changes in light and glare sensitivity, changes in visual acuity, and any additional ocular changes attributable to the device.
Surgical implantation of Morcher iris device(s)
Aniridia is a condition where the iris, the colored portion of the eye, is either partially or completely absent. The iris is responsible for regulating the amount of light that enters the eye by adjusting the size of the pupil opening.
Aniridia can either be a congenital condition, a genetics-based abnormality affecting the formation of the iris, or it can be acquired through surgical or physical trauma to the eye.
Aniridia can also vary in the level of severity—a mild case would involve a thinner iris or iris remnant with a normal pupil. A severe case may involve complete absence of the iris and impairment of the muscles responsible for adjusting pupil size.
People who suffer from aniridia also commonly suffer from other eye conditions. The more common ones include glaucoma, cataract, and nystagmus. Often, other structures in the eye are affected including the cornea, the natural lens, and the retina. Aniridia can cause severe visual disability if left untreated.
Common treatments for aniridia involve having the patient use colored or tinted glasses or contact lenses to reduce the amount of light entering the eye.
In this trial, Morcher Iris Diaphragms are being evaluated as a potential treatment to improve the symptoms associated with aniridia.The Morcher Iris Diaphragm is a device manufactured in Germany by Morcher GmbH [website: http:// www.morcher.com]. In Europe, these devices have been utilized to treat aniridic patients for over 25 years. Additionally, these devices hold the European CE mark of conformity.
When a patient is implanted with a Morcher Iris Diaphragm, their surgery involves additional standard of care surgical procedures. Typically, a device is implanted during cataract surgery along with an intraocular lens (IOL). Devices can also be implanted during an IOL exchange procedure or IOL exchange with anterior vitrectomy. All implantation procedures take place in an operating room under local or general anesthesia. In some cases, a single-piece Morcher iris reconstruction lens containing both an artificial iris and a lens is implanted. Also, depending on the patient, and the condition of their eye, the lens and device implant may need to be sutured in place. Typically, this involves suturing the lens to the iris device and then, suturing this all to the sclera, the white portion of the eye.
All patients undergoing surgery are prescribed two different eye drops, an antibiotic and a corticosteroid. These medications are used for up to a maximum of 6 weeks following implantation of the device. There are five postoperative follow-up visits that every patient must complete. All visits are spaced out at specific intervals over the course of a one-year period. At each visit, standard of care procedures are performed and, at certain time points in this follow-up interval, digital photos and endothelial cell counts are obtained. In the cases where both eyes will be implanted, surgery for each eye will be scheduled 6 months apart.
As of June 2014, Sixty-six patients had been implanted with the Morcher Iris Diaphragms, and all completed the one-year post-operative follow-up period. The study is currently in the data analysis phase. No patients are being enrolled currently.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812708
|United States, California|
|Jules Stein Eye Institute, UCLA|
|Los Angeles, California, United States, 90095-7002|
|Principal Investigator:||Kevin M Miller, MD||University of California, Los Angeles|