Clinical Evaluation of Morcher Artificial Iris Diaphragms

NCT00812708 | Completed Results DMC

• 1 other identifier: 02-06-072
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aniridia; Iris; Deformity

Keywords

aniridia; Morcher iris diaphragms; modified capsule tension ring; artificial iris; iris reconstruction lens; glare sensitivity; photophobia

Outcome Measures

Primary Outcomes (2)

• Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)

  The primary efficacy measure of the study was the change in corrected distance visual acuity (CDVA) under glare conditions. A transilluminator light was held just in front of the distance corrected study eye in one of four quadrants (above, below, nasal, or temporal) to the line of sight to evoke a glare response. The direction that produced the worst CDVA was called the CDVA with glare. A ≥ 2 line improvement in Snellen CDVA with glare following Morcher device implantation was considered a positive clinical change (glare sensitivity better). A ≥ 2 line worsening of Snellen CDVA with glare following Morcher device implantation was considered a negative clinical change (glare sensitivity worse). A change of \< 2 Snellen lines following Morcher device implantation was considered to be a neutral change (glare sensitivity the same).

  Preoperatively and 1 year postoperatively

• Change in Best Corrected Visual Acuity (Primary Safety Measure)

  The primary safety measure of the study was the change in best corrected distance visual acuity (CDVA) as measured using a Snellen eye chart. A ≥ 2 line improvement in Snellen CDVA following Morcher device implantation was considered a positive clinical change (visual acuity better). A ≥ 2 line worsening of Snellen CDVA following Morcher device implantation was considered a negative clinical change (visual acuity worse). A change of \< 2 lines was considered to be a neutral change (visual acuity the same).

  Preoperatively and 1 year postoperatively

Secondary Outcomes (4)

• Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure)

  Preoperatively and 3 months postoperatively

• Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure)

  Preoperatively and 3 months postoperatively

• Change in Endothelial Cell Count (Secondary Safety Measure)

  Preoperatively and 3 months postoperatively

• Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure)

  Preoperatively and 1 year postoperatively

Study Arms (1)

Morcher iris diaphragm implantation

EXPERIMENTAL

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

Interventions

Morcher iris diaphragm implantation DEVICE

Surgical implantation of Morcher iris device(s)

Also known as: Morcher device models: 96F, 96S, 50D, 50F, and 67B

Morcher iris diaphragm implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Stein Eye Institute, UCLA

Los Angeles, California, 90095-7000, United States

Location

Related Publications (6)

• 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.

  PMID: 19265334 BACKGROUND

• 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.

  PMID: 18812117 RESULT

• 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.

  PMID: 26603402 RESULT

• 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.

  PMID: 27373394 RESULT

• 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.

  PMID: 29515428 RESULT

• 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.

  PMID: 30041739 RESULT

MeSH Terms

Conditions

Aniridia; Congenital Abnormalities; Photophobia

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Eye Diseases, Hereditary; Iris Diseases; Uveal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kevin M. Miller, MD
• Organization: University of California Los Angeles

millerpatients@jsei.ucla.edu

(310) 206-9951

Study Officials

• Kevin M Miller, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kolokotrones Chair in Ophthalmology

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: April 9, 2003
• Primary Completion: June 20, 2014
• Study Completion: December 7, 2021
• Last Updated: December 15, 2021
• Results First Posted: June 28, 2018

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)