AniridiaNCT00812708
Clinical Evaluation of Morcher Artificial Iris Diaphragms
A study testing Morcher iris diaphragm implantation in people with Aniridia and Iris; Deformity, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aniridia, Iris; Deformity
- What is being tested?
- Morcher iris diaphragm implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2003to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stein Eye Institute, UCLA
Los Angeles, California, 90095-7000
About this study
Official title: Clinical Evaluation of Morcher Artificial Iris Diaphragms to Treat Light and Glare Sensitivity in Partial or Complete Aniridia
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.
Read the 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.
- Conditions
- Aniridia, Iris; Deformity
- Being tested
- Morcher iris diaphragm implantation
- Keywords
- aniridia, Morcher iris diaphragms, modified capsule tension ring, artificial iris, iris reconstruction lens, glare sensitivity, photophobia
- Medical subject headings
- Aniridia, Congenital Abnormalities, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morcher iris diaphragm implantationDevice
Also called Morcher device models: 96F, 96S, 50D, 50F, and 67B
Surgical implantation of Morcher iris device(s)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Morcher iris diaphragm implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Preoperatively and 1 year postoperatively
Secondary outcomes (4)
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.
Measured: Preoperatively and 3 months postoperatively
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.
Measured: Preoperatively and 3 months postoperatively
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.)
Measured: Preoperatively and 3 months postoperatively
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.
Measured: Preoperatively and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study start9 Apr 2003
- Primary completion20 Jun 2014
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AniridiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin M. Miller, MD, University of California, Los Angeles
- Investigators
- Kevin M Miller, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812708
- Sponsor's protocol ID
- 02-06-072
- Status last verified
- Dec 2021
- First submitted
- 19 Dec 2008
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19265334Olson 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.
PubMed 18812117Date 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.
PubMed 26603402Miller 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.
PubMed 27373394Lin 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.
PubMed 29515428Miller 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.
PubMed 30041739
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Morcher Artificial Iris Diaphragms to Treat Light and Glare Sensitivity in Partial or Complete Aniridia
- ClinicalTrials.gov ID
- NCT00812708
- Acronym / sponsor ID
- 02-06-072
- Conditions
- Aniridia, Iris; Deformity
- Keywords
- aniridia, Morcher iris diaphragms, modified capsule tension ring, artificial iris, iris reconstruction lens, glare sensitivity, photophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 9 Apr 2003 (actual)
- Primary completion
- 20 Jun 2014 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 28 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morcher iris diaphragm implantation | Experimental | Device: Morcher iris diaphragm implantationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morcher iris diaphragm implantationAlso: Morcher device models: 96F, 96S, 50D, 50F, and 67BSurgical implantation of Morcher iris device(s) | Device | Morcher iris diaphragm implantation |
Primary outcome
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)
Time frame: 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)
Time frame: 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).
4 secondary outcomes
Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure)
Time frame: Preoperatively and 3 months postoperatively
Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure)
Time frame: Preoperatively and 3 months postoperatively
Change in Endothelial Cell Count (Secondary Safety Measure)
Time frame: Preoperatively and 3 months postoperatively
Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure)
Time frame: Preoperatively and 1 year postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19265334Chung 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.
- Results publication: PubMed 18812117Olson 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.
- Results publication: PubMed 26603402Date 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.
- Results publication: PubMed 27373394Miller 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.
- Results publication: PubMed 29515428Lin 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.
- Results publication: PubMed 30041739Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin M Miller, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morcher iris diaphragm implantation in people with Aniridia and Iris; Deformity, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) (time frame: Preoperatively and 1 year postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00812708, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.