Morcher Artificial Iris Devices to Treat Light and Glare Sensitivity in Partial or Complete Aniridia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Kevin M. Miller, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00812708
First received: December 19, 2008
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to determine the safety and effectiveness of Morcher artificial iris devices in the treatment of congenital and acquired aniridia.


Condition Intervention Phase
Aniridia
Device: Surgery
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use Study of Morcher Artificial Iris Devices to Treat Light and Glare Sensitivity in Partial or Complete Aniridia

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change from baseline in best-corrected glare visual acuity (BCGVA) at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare conditions is considered a positive outcome.


Secondary Outcome Measures:
  • Reduction of 15% or more of the central endothelial cell density is considered an adverse safety event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Endothelial cell count to measure cell density at 3 months post-operative status

  • Need to explant or exchange the Morcher Iris Diaphragm [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in best-corrected visual acuity (BCVA) at 2 weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: Yes ]
    Visual Acuity test under non glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.

  • Change from baseline in best-corrected visual acuity (BCVA) at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]
    Visual Acuity test under non-glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.

  • Change from baseline in best-corrected visual acuity (BCVA) at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    Visual Acuity test under non glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.

  • Change from baseline in best-corrected visual acuity (BCVA) at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
    Visual Acuity test under non glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.

  • Change from baseline in best-corrected glare visual acuity (BCGVA) at 2 weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare test conditions is considered a positive outcome.

  • Change from baseline in best-corrected glare visual acuity (BCGVA) at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare test conditions is considered a positive outcome.

  • Change from baseline in best-corrected glare visual acuity (BCGVA) at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare conditions is considered a positive outcome.


Estimated Enrollment: 70
Study Start Date: September 2002
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2028 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morcher artificial iris implantation
A Morcher artificial iris will be implanted inside the eye. Reduction in glare sensitivity and other outcomes will be measured.
Device: Surgery
Surgical implantation of Morcher iris device(s)
Other Names:
  • Morcher modified capsule tension rings (models 96F and 50F)
  • Morcher iris reconstruction lens (model 67B)

Detailed Description:

Congenital aniridia is a rare genetic condition that results in the abnormal development of the iris (colored part) of the eye. This genetically inherited disorder occurs in approximately 1/60,000 to 1/100,000 births. Severe cases can result in the complete absence of the iris and the muscles that open and close the pupil. Mild cases can result in a thinner iris with a normal pupil. About half of the people with this condition also develop early cataracts that need to be removed in their 20's or 30's. Most have glaucoma, which is difficult to control. Vision is usually decreased by significant glare because the iris is not present to control the amount of light entering the eye. Vision can also be limited because of the presents of cataracts, glaucoma, and a condition called nystagmus in which there are uncontrollable jerking eye movements. The only treatment for aniridia is the use of colored glasses or contact lenses with images of an iris painted on them to reduce the amount of light entering the eye.

Acquired aniridia is more common than congenital aniridia. Acquired aniridia may be partial or complete and may be caused by trauma or surgery. Often the cornea, lens, and/or retina are affected simultaneously, resulting in severe visual disability.

Morcher GmbH, a German company, manufactures the iris diaphragms. Their web site is http://www.morcher.com. Morcher artificial iris devices are designed to reduce the significant light and glare sensitivity that patients experience with aniridia. These devices have been used in Europe for over 20 years. They hold the European CE mark of conformity and have been certified through the Active Implantable Medical Device Directive (AIMDD) since 1994.

Implantation of a Morcher iris diaphragm is performed in association with other standard of care surgical procedures, which include cataract surgery with intraocular lens (IOL) implantation, IOL exchange, and/or anterior vitrectomy. These procedures are performed in an operating room under local or general anesthesia. The IOL and the iris diaphragm are placed into the eye through an incision in the cornea. The IOL is placed in the eye behind the normal position of the iris, inside the lens capsule if it remains following cataract removal. The iris diaphragm is placed in front of the IOL. In some cases a single-piece iris reconstruction lens containing an artificial iris and lens is implanted. If the capsule can not support an IOL and iris implant, they are sutured in place through the sclera, the white part of the eye. Two different medication eye drops are used for 4 to 6 weeks following surgery. Patients are required to return for 5 postoperative visits at intervals of 1 day, 2 weeks, 3, 6, and 12 months. Standard testing occurs at each of these visits and require approximately 1 to 2 hours of the patient's time. Color photographs of the eye and endothelial cell counts are obtained preoperatively and 3 months postoperatively. If required, the same procedure for the other eye may be performed 6 months after first eye surgery.

61 patients have been enrolled as of August 2012.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 IOL 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812708

Contacts
Contact: Kevin M Miller, MD 310-206-9951 kmiller@ucla.edu
Contact: Manali S Shah, MS 310-206-1634 shah@jsei.ucla.edu

Locations
United States, California
Jules Stein Eye Institute, UCLA Recruiting
Los Angeles, California, United States, 90095-7002
Principal Investigator: Kevin M Miller, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Kevin M Miller, MD University of California, Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Kevin M. Miller, MD, Kolokotrones Professor of Clinical Ophthalmology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00812708     History of Changes
Other Study ID Numbers: 02-06-072
Study First Received: December 19, 2008
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
aniridia
Morcher iris diaphragms
modified capsule tension ring
artificial iris
iris reconstruction lens
glare sensitivity
photophobia

Additional relevant MeSH terms:
Aniridia
Eye Abnormalities
Eye Diseases
Eye Diseases, Hereditary
Iris Diseases
Uveal Diseases
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 28, 2014