Aniridia, Iris; Deformity
Conditions
Keywords
aniridia, Morcher iris diaphragms, modified capsule tension ring, artificial iris, iris reconstruction lens, glare sensitivity, photophobia
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.
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.
Interventions
DEVICEMorcher iris diaphragm implantation
Surgical implantation of Morcher iris device(s)
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Most patients were recruited from the principal investigator's ophthalmic practice. A few were referred by local ophthalmologists.
Participants by arm
| Arm | Count |
|---|---|
| Morcher Iris Diaphragm Study Group Seventy two patients signed consent forms to participate in the Morcher iris diaphragm study. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device could not be implanted | 2 |
| Overall Study | Lack of medical insurance | 1 |
| Overall Study | Signed consent but later withdrew | 3 |
| Overall Study | Surgery cancelled due to uveitis | 1 |
| Overall Study | Switched to another study | 1 |
Baseline characteristics
| Characteristic | Morcher Iris Diaphragm Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 72 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 64 |
| other Total, other adverse events | 5 / 64 |
| serious Total, serious adverse events | 6 / 64 |
Outcome results
Primary
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).
Time frame: Preoperatively and 1 year postoperatively
Population: This group consisted of all patients implanted with Morcher iris diaphragms.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morcher Iris Diaphragm Implantation Group | Change in Best Corrected Visual Acuity (Primary Safety Measure) | Visual acuity better | 35 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Best Corrected Visual Acuity (Primary Safety Measure) | Visual acuity the same | 28 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Best Corrected Visual Acuity (Primary Safety Measure) | Visual acuity worse | 1 Participants |
Primary
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).
Time frame: Preoperatively and 1 year postoperatively
Population: This group consisted of all patients implanted with Morcher iris diaphragms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morcher Iris Diaphragm Implantation Group | Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) | Glare sensitivity better | 51 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) | Glare sensitivity the same | 12 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) | Glare sensitivity worse | 1 Participants |
Secondary
Change in Endothelial Cell Count (Secondary Safety Measure)
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morcher Iris Diaphragm Implantation Group | Change in Endothelial Cell Count (Secondary Safety Measure) | Endothelial cell loss ≤ 10% | 17 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Endothelial Cell Count (Secondary Safety Measure) | Endothelial cell loss > 10% | 18 Participants |
Secondary
Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure)
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
Population: This group consisted of all patients implanted with Morcher iris diaphragms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morcher Iris Diaphragm Implantation Group | Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) | Subjective day time glare sensitivity better | 57 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) | Subjective day time glare sensitivity the same | 5 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) | Subjective day time glare sensitivity worse | 2 Participants |
Secondary
Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure)
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morcher Iris Diaphragm Implantation Group | Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) | Subjective night time glare sensitivity better | 56 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) | Subjective night time glare sensitivity the same | 5 Participants |
| Morcher Iris Diaphragm Implantation Group | Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) | Subjective night time glare sensitivity worse | 3 Participants |
Secondary
Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure)
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
Population: This group consisted of all patients implanted with Morcher iris diaphragms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morcher Iris Diaphragm Implantation Group | Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) | Morcher device explanted | 1 Participants |
| Morcher Iris Diaphragm Implantation Group | Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) | Morcher device not explanted | 63 Participants |