Clinical Evaluation of Morcher Artificial Iris Diaphragms
NCT ID: NCT00812708
Last Updated: 2021-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2003-04-09
2021-12-07
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Morcher iris diaphragm implantation
Surgical implantation of Morcher iris device(s)
Interventions
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Morcher iris diaphragm implantation
Surgical implantation of Morcher iris device(s)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Kevin M. Miller, MD
Kolokotrones Chair in Ophthalmology
Principal Investigators
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Kevin M Miller, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Stein Eye Institute, UCLA
Los Angeles, California, United States
Countries
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References
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Chung MY, Miller KM, Weissman BA. Morcher iris reconstruction lens and rigid contact lens for traumatic aniridia. Eye Contact Lens. 2009 Mar;35(2):108-10. doi: 10.1097/ICL.0b013e318199b00b.
Olson MD, Masket S, Miller KM. Interim results of a compassionate-use clinical trial of Morcher iris diaphragm implantation: report 1. J Cataract Refract Surg. 2008 Oct;34(10):1674-80. doi: 10.1016/j.jcrs.2008.05.048.
Date RC, Olson MD, Shah M, Masket S, Miller KM. Outcomes of a modified capsular tension ring with a single black occluder paddle for eyes with congenital and acquired iris defects: Report 2. J Cataract Refract Surg. 2015 Sep;41(9):1934-44. doi: 10.1016/j.jcrs.2015.10.001.
Miller KM, Nicoli CM, Olson MD, Shah M, Masket S. Outcomes of implantation of modified capsule tension rings with multiple black occluder paddles for eyes with congenital and acquired iris defects: Report 3. J Cataract Refract Surg. 2016 Jun;42(6):870-8. doi: 10.1016/j.jcrs.2016.03.035.
Lin SR, Miller KM. Lessons Learned from Implantation of Morcher 50D and 96S Artificial Iris Diaphragms. Case Rep Ophthalmol. 2017 Nov 23;8(3):527-534. doi: 10.1159/000484128. eCollection 2017 Sep-Dec.
Miller KM, Kuo A, Olson MD, Masket S. Safety and efficacy of black iris diaphragm intraocular lens implantation in eyes with large iris defects: Report 4. J Cataract Refract Surg. 2018 Jun;44(6):686-700. doi: 10.1016/j.jcrs.2018.03.033. Epub 2018 Jul 4.
Other Identifiers
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02-06-072
Identifier Type: -
Identifier Source: org_study_id