Clinical Evaluation of Morcher Artificial Iris Diaphragms
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| 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)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) [Preoperatively and 1 year postoperatively]
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).
- Change in Best Corrected Visual Acuity (Primary Safety Measure) [Preoperatively and 1 year postoperatively]
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).
Secondary Outcome Measures
- Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) [Preoperatively and 3 months postoperatively]
A secondary efficacy measure of the study was day time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.
- Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) [Preoperatively and 3 months postoperatively]
Another secondary efficacy measure of the study was night time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.
- Change in Endothelial Cell Count (Secondary Safety Measure) [Preoperatively and 3 months postoperatively]
A secondary safety measure of the study was the change in endothelial cell count. A loss of >10% of central corneal endothelial cells was considered clinically significant at the onset of the study. (Note, the 10% loss criterion was established before the 67B implant was added to the list of study devices. The 67B implant has an expected greater cell loss than that associated with the 96F, 96S, 50D, and 50F modified capsule tension rings because it requires a larger incision for implantation. Thirty one (48.4%) of the 64 patients were implanted with the 67B device.)
- Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) [Preoperatively and 1 year postoperatively]
Another secondary safety measure of the study was the need to explant or exchange a Morcher iris diaphragm within 1 year of implantation. Explantation in < 25% of patients was considered to be clinically acceptable.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stein Eye Institute, UCLA | Los Angeles | California | United States | 90095-7000 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Kevin M Miller, MD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Related article: Iris Prosthetics. Advanced Ocular Care. December 2010
- Related article: Cataract and lost iris tissue after trauma. Cataract & Refractive Surgery Today. January 2012
Publications
- 02-06-072
Study Results
Participant Flow
| Recruitment Details | Most patients were recruited from the principal investigator's ophthalmic practice. A few were referred by local ophthalmologists. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Morcher Iris Diaphragm Study Group |
|---|---|
| Arm/Group Description | This group consists of all patients enrolled in the Morcher iris diaphragm study. |
| Period Title: Overall Study | |
| STARTED | 72 |
| Taken to Surgery for Device Implantation | 66 |
| COMPLETED | 64 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Morcher Iris Diaphragm Study Group |
|---|---|
| Arm/Group Description | Seventy two patients signed consent forms to participate in the Morcher iris diaphragm study. |
| Overall Participants | 72 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
47
65.3%
|
| >=65 years |
25
34.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
21
29.2%
|
| Male |
51
70.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
8
11.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
2
2.8%
|
| White |
47
65.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
15
20.8%
|
| Region of Enrollment (Count of Participants) | |
| United States |
72
100%
|
Outcome Measures
| Title | Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) |
|---|---|
| Description | 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). |
| Time Frame | Preoperatively and 1 year postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| This group consisted of all patients implanted with Morcher iris diaphragms. |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group |
|---|---|
| Arm/Group Description | All patients implanted with Morcher iris diaphragms. |
| Measure Participants | 64 |
| Glare sensitivity better |
51
70.8%
|
| Glare sensitivity the same |
12
16.7%
|
| Glare sensitivity worse |
1
1.4%
|
| Title | Change in Best Corrected Visual Acuity (Primary Safety Measure) |
|---|---|
| Description | 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). |
| Time Frame | Preoperatively and 1 year postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| This group consisted of all patients implanted with Morcher iris diaphragms. |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group |
|---|---|
| Arm/Group Description | All patients implanted with Morcher iris diaphragms. |
| Measure Participants | 64 |
| Visual acuity better |
35
48.6%
|
| Visual acuity the same |
28
38.9%
|
| Visual acuity worse |
1
1.4%
|
| Title | Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) |
|---|---|
| Description | A secondary efficacy measure of the study was day time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant. |
| Time Frame | Preoperatively and 3 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| This group consisted of all patients implanted with Morcher iris diaphragms. |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group |
|---|---|
| Arm/Group Description | Glare sensitivity was assessed by a questionnaire that was scored on a 0 to 10 scale under daytime and nighttime lighting conditions. |
| Measure Participants | 64 |
| Subjective day time glare sensitivity better |
57
79.2%
|
| Subjective day time glare sensitivity the same |
5
6.9%
|
| Subjective day time glare sensitivity worse |
2
2.8%
|
| Title | Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) |
|---|---|
| Description | Another secondary efficacy measure of the study was night time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant. |
| Time Frame | Preoperatively and 3 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group |
|---|---|
| Arm/Group Description | Glare sensitivity was assessed by a questionnaire that was scored on a 0 to 10 scale under daytime and nighttime lighting conditions. |
| Measure Participants | 64 |
| Subjective night time glare sensitivity better |
56
77.8%
|
| Subjective night time glare sensitivity the same |
5
6.9%
|
| Subjective night time glare sensitivity worse |
3
4.2%
|
| Title | Change in Endothelial Cell Count (Secondary Safety Measure) |
|---|---|
| Description | A secondary safety measure of the study was the change in endothelial cell count. A loss of >10% of central corneal endothelial cells was considered clinically significant at the onset of the study. (Note, the 10% loss criterion was established before the 67B implant was added to the list of study devices. The 67B implant has an expected greater cell loss than that associated with the 96F, 96S, 50D, and 50F modified capsule tension rings because it requires a larger incision for implantation. Thirty one (48.4%) of the 64 patients were implanted with the 67B device.) |
| Time Frame | Preoperatively and 3 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| This group consisted of all patients implanted with Morcher iris diaphragms, for whom simultaneous corneal transplantation was not performed, and in whom endothelial cell counts could be obtained preoperatively and postoperatively. |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group |
|---|---|
| Arm/Group Description | All patients implanted with Morcher iris diaphragms. |
| Measure Participants | 35 |
| Endothelial cell loss ≤ 10% |
17
23.6%
|
| Endothelial cell loss > 10% |
18
25%
|
| Title | Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) |
|---|---|
| Description | Another secondary safety measure of the study was the need to explant or exchange a Morcher iris diaphragm within 1 year of implantation. Explantation in < 25% of patients was considered to be clinically acceptable. |
| Time Frame | Preoperatively and 1 year postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| This group consisted of all patients implanted with Morcher iris diaphragms. |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group |
|---|---|
| Arm/Group Description | All patients implanted with Morcher iris diaphragms. |
| Measure Participants | 64 |
| Morcher device explanted |
1
1.4%
|
| Morcher device not explanted |
63
87.5%
|
Adverse Events
| Time Frame | Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines. | |
| Arm/Group Title | Morcher Iris Diaphragm Implantation Group | |
| Arm/Group Description | All patients implanted with Morcher iris diaphragms | |
All Cause Mortality |
||
| Morcher Iris Diaphragm Implantation Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/64 (0%) | |
Serious Adverse Events |
||
| Morcher Iris Diaphragm Implantation Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/64 (9.4%) | |
| Eye disorders | ||
| Decentered piggyback intraocular lens | 1/64 (1.6%) | 1 |
| Retained lens fragment | 1/64 (1.6%) | 1 |
| Corneal failure | 1/64 (1.6%) | 1 |
| Corneal graft-host interface leak | 1/64 (1.6%) | 1 |
| Morcher iris diaphragm rotation | 1/64 (1.6%) | 1 |
| Retinal detachment | 1/64 (1.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Morcher Iris Diaphragm Implantation Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/64 (7.8%) | |
| Eye disorders | ||
| Intraoperative hyphema | 1/64 (1.6%) | 1 |
| Cystoid macular edema | 1/64 (1.6%) | 1 |
| Acute iritis | 1/64 (1.6%) | 1 |
| Ocular hypertension | 2/64 (3.1%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kevin M. Miller, MD |
|---|---|
| Organization | University of California Los Angeles |
| Phone | (310) 206-9951 |
| millerpatients@jsei.ucla.edu |
- 02-06-072