Limbal Stem-cell DeficiencyPhase 1NCT05909735
Treatment of LSCD With DM
A Phase 1 study testing transplantation of a Descemet's Membrane corneal onlay, partial LSCD and transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD in people with Limbal Stem-cell Deficiency and Congenital Aniridia, run by University of Minnesota at 1 site in United States.
Trial summary
Limbal Stem Cell Deficiency (LSCD) is a blinding disease that accounts for an estimated 15-20% of corneal blindness worldwide. Current treatments are limited. Traditional corneal transplantation with penetrating keratoplasty (PKP) is ineffective in treating these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limbal Stem-cell Deficiency, Congenital Aniridia
- What is being tested?
- transplantation of a Descemet's Membrane corneal onlay, partial LSCD and transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Arm 1:
- partial LSCD (involving less than 75% of the limbus, or <75% of the corneal surface)
- Visually significant (best-corrected visually acuity 20/100 or worse)
- Arm 2:
- total/near-total LSCD with recurrent erosions or PEDs (involving more than 75% of the limbus, or more than 75% of the corneal surface)
- Visually significant (best-corrected visually acuity 20/100 or worse) PLUS
- Persistent epithelial defects last >2 weeks despite maximal medical therapy OR
- Recurrent erosions occuring at least once every month
Who cannot join
- Pregnant women
- Prisoners (vulnerable population)
- Adults lacking capacity to consent (vulnerable population)
- Adults unable to sign consent due to non-english speaking or illiterate (vulnerable population)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Treatment of Limbal Stem Cell Deficiency With Descemet's Membrane
Limbal Stem Cell Deficiency (LSCD) is a blinding disease that accounts for an estimated 15-20% of corneal blindness worldwide. Current treatments are limited. Traditional corneal transplantation with penetrating keratoplasty (PKP) is ineffective in treating these patients. Without a healthy population of limbal stem cells (LSC) to regenerate the corneal epithelium, standard corneal transplants will not re-epithelialize and will rapidly scar over or melt.
The limbal niche is the microenvironment surrounding the LSCs that is critical for maintaining their survival and proliferative potential under physiologic conditions. Extracellular signals from the microenvironment are critical to the normal function and maintenance of pluripotent stem cells. Identifying an effective niche replacement is thus an important focus of limbal stem cell research and critical for advancing treatments for LSCD.
Read more
Descemet's membrane (DM), an acellular, naturally occurring, basement membrane found on the posterior surface of the cornea, is a promising niche replacement. DM is routinely isolated and transplanted intraocularly with associated donor corneal endothelium for treatment of diseases like Fuchs' dystrophy and corneal bullous keratopathy that specifically affect DM and corneal endothelium. However, its application on the ocular surface has not been explored. DM is optically clear and highly resistant to collagenase digestion. This makes it very attractive as a long-term corneal on-lay and niche replacement on the surface of the eye. The anterior fetal banded layer of DM shares key compositional similarities with limbal basement membrane, which is a major component of the limbal niche. These similarities include limbus-specific extracellular matrix proteins such as collagen IV that is restricted to the α1, α2 subtypes, vitronectin, and BM40/SPARC. Of these, vitronectin and BM40/SPARC are known to promote proliferation of LSCs and induced pluripotent stem cells (iPSC) in culture.
Because of this, DM is a promising biological membrane for establishing a niche-like substrate on the corneal surface in patients with LSCD. The purpose of this pilot study is to investigate the clinical efficacy of using DM as a corneal on-lay to promote corneal re-epithelialization in partial LSCD.
- Conditions
- Limbal Stem-cell Deficiency, Congenital Aniridia
- Being tested
- transplantation of a Descemet's Membrane corneal onlay, partial LSCD, transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD
- Keywords
- congenital aniridia, limbal stem cell deficiency, Descemet's Membrane
- Medical subject headings
- Limbal Stem Cell Deficiency, Aniridia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantation of a Descemet's Membrane corneal onlay, partial LSCDProcedure or surgery
The worst seeing eye of these patients (or a randomized eye if vision is equal bilaterally) will be treated with superficial keratectomy to remove any pannus and debride the central corneal epithelium, followed by transplantation of a Descemet's membrane corneal onlay. Patient will be followed for 6 months and evaluated for improvement in visual acuity and improvement in limbal stem cell deficiency, and monitored for adverse events.
transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCDProcedure or surgery
The worst seeing eye of these patients (or a randomized eye if vision is equal bilaterally) will be treated with superficial keratectomy to remove any pannus and debride the central corneal epithelium, followed by transplantation of a Descemet's membrane (DM) corneal onlay. Patient will be followed for 6 months and evaluated for improvement in visual acuity, limbal stem cell deficiency, and persistent epithelial defects/recurrent erosions, and monitored for adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Visually significant partial LSCD | Experimental | Patient with visually significant partial LSCD, as defined by a best corrected visual acuity of 20/100 or less, and partial LSCD on slit lamp exam with at least 25% of the limbus intact or at least 25% of the corneal surface covered with corneal epithelium will be enrolled in the first arm. Receives: Procedure: transplantation of a Descemet's Membrane corneal onlay, partial LSCD |
| Total/near-total LSCD with recurrent or persistent epithelial defects (PED) | Experimental | Patient with visually significant total LSCD, as defined by a best corrected visual acuity of 20/100 or less, and total LSCD on slit lamp exam with over 25% of the limbus intact or less than 25% of the corneal surface covered with corneal epithelium; and a history of a persistent epithelial defect that has persisted over 2 weeks despite maximal medical therapy, or a history of recurrent epithelial erosions that occur more frequently than once a month; will be enrolled in the second arm. Receives: Procedure: transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual improvement
Visual Acuity: Improvement in visual acuity over time will be measured as the difference in post-op visual acuity at post-operative week 1, month 1, month 3, and month 6 compared to pre-op visual acuity. Visual acuity will be assessed in study eyes with a standard Snellen Eye Chart.
Measured: 180 days following intervention
Graft Retention on Slit Lamp Examination
Retention of the graft: Retention of the graft on the surface of the eye will be documented as present, absent, or indeterminant using slit lamp examination. For slit lamp examination, retention of the graft will be evidenced by visualization of a gentian violet orientation mark (s-stamp) that will be placed on all grafts at the time of tissue processing by the eye bank (prior to transplantation).
Measured: 180 days following intervention
Graft Retention on Slit Lamp Photography.
Retention of the graft: In order to maintain photographic proof of the findings on slit lamp examination, slit lamp photography will also be taken. Study eyes will be photographed at the slit lamp at post-operative week 1, month 1, month 3, and month 6. Retention of the graft will be evidenced by visualization of a gentian violet orientation mark (s-stamp) that will be placed on all grafts at the time of tissue processing by the eye bank (prior to transplantation). This photographic documentation will assist in confirming the findings in outcome measure #2.
Measured: 180 days following intervention
Incidence of Post-operative Adverse Events Requiring Treatment
Post-operative adverse events: Patients will be assessed at slit lamp at post-operative week 1, month 1, month 3, and month 6 for dislocation or opacification of the DM corneal onlay, PEDs, elevated intraocular pressure (IOP), and/or infectious keratitis to assess the safety of the therapy. Any persistent epithelial defect will be measured for size on slit lamp by recording the long and short diameter of any defect. IOP will be measured using a Goldman applanation. Infectious keratitis and membrane dislocation will be assessed at slit lamp during each post-operative visit.
Measured: 180 days following intervention
Corneal Neovascularization on Slit Lamp Examination
Corneal Neovascularization: will be evaluated using slit lamp examination pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal neovascularization will be quantified using a previously established 10-point slit lamp examination score based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Measured: 180 days following intervention
Corneal Neovascularization on Slit Lamp Photography
In order to maintain photographic proof of the findings on slit lamp examination, slit lamp photography will also be taken. Photos will be taken pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal neovascularization on the photos will be compared to the documented 10-point slit lamp examination score from outcomes measure #6 to confirm the accuracy of the results. Again, the 10-point slit lamp examination score is based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Measured: 180 days following intervention
Corneal Epitheliopathy on Slit Lamp Examination
Corneal Epitheliopathy: will be evaluated using slit lamp examination pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal epitheliopathy will be quantified using a previously established 10-point slit lamp examination score based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Measured: 180 days following intervention
Corneal Epitheliopathy on Slit Lamp Photography
In order to maintain photographic proof of the findings on slit lamp examination, slit lamp photography will also be taken. Photos will be taken pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal epitheliopathy on the photos will be compared to the documented 10-point slit lamp examination score from outcomes measure #8 to confirm the accuracy of the results. Again, the 10-point slit lamp examination score is based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Measured: 180 days following intervention
Corneal epithelial thickness
Corneal epithelial thickness will be assessed as a metric of LSCD severity. Corneal epithelial thickness will be measured in cross-section on AS-OCT only.
Measured: 180 days following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start30 Nov 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem-cell DeficiencyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an interventional non-comparative pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Kaufman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909735
- Sponsor's protocol ID
- OPH-2023-31727
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Limbal Stem Cell Deficiency With Descemet's Membrane
- ClinicalTrials.gov ID
- NCT05909735
- Acronym / sponsor ID
- OPH-2023-31727
- Conditions
- Limbal Stem-cell Deficiency, Congenital Aniridia
- Keywords
- congenital aniridia, limbal stem cell deficiency, Descemet's Membrane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Limbal Stem Cell Deficiency (LSCD) is a blinding disease that accounts for an estimated 15-20% of corneal blindness worldwide. Current treatments are limited. Traditional corneal transplantation with penetrating keratoplasty (PKP) is ineffective in treating these patients. Without a healthy population of limbal stem cells (LSC) to regenerate the corneal epithelium, standard corneal transplants will not re-epithelialize and will rapidly scar over or melt.
The limbal niche is the microenvironment surrounding the LSCs that is critical for maintaining their survival and proliferative potential under physiologic conditions. Extracellular signals from the microenvironment are critical to the normal function and maintenance of pluripotent stem cells. Identifying an effective niche replacement is thus an important focus of limbal stem cell research and critical for advancing treatments for LSCD.
Descemet's membrane (DM), an acellular, naturally occurring, basement membrane found on the posterior surface of the cornea, is a promising niche replacement. DM is routinely isolated and transplanted intraocularly with associated donor corneal endothelium for treatment of diseases like Fuchs' dystrophy and corneal bullous keratopathy that specifically affect DM and corneal endothelium. However, its application on the ocular surface has not been explored. DM is optically clear and highly resistant to collagenase digestion. This makes it very attractive as a long-term corneal on-lay and niche replacement on the surface of the eye. The anterior fetal banded layer of DM shares key compositional similarities with limbal basement membrane, which is a major component of the limbal niche. These similarities include limbus-specific extracellular matrix proteins such as collagen IV that is restricted to the α1, α2 subtypes, vitronectin, and BM40/SPARC. Of these, vitronectin and BM40/SPARC are known to promote proliferation of LSCs and induced pluripotent stem cells (iPSC) in culture.
Because of this, DM is a promising biological membrane for establishing a niche-like substrate on the corneal surface in patients with LSCD. The purpose of this pilot study is to investigate the clinical efficacy of using DM as a corneal on-lay to promote corneal re-epithelialization in partial LSCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional non-comparative pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Visually significant partial LSCD | Experimental | Procedure: transplantation of a Descemet's Membrane corneal onlay, partial LSCDPatient with visually significant partial LSCD, as defined by a best corrected visual acuity of 20/100 or less, and partial LSCD on slit lamp exam with at least 25% of the limbus intact or at least 25% of the corneal surface covered with corneal epithelium will be enrolled in the first arm. |
| Total/near-total LSCD with recurrent or persistent epithelial defects (PED) | Experimental | Procedure: transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCDPatient with visually significant total LSCD, as defined by a best corrected visual acuity of 20/100 or less, and total LSCD on slit lamp exam with over 25% of the limbus intact or less than 25% of the corneal surface covered with corneal epithelium; and a history of a persistent epithelial defect that has persisted over 2 weeks despite maximal medical therapy, or a history of recurrent epithelial erosions that occur more frequently than once a month; will be enrolled in the second arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- partial LSCD (involving less than 75% of the limbus, or <75% of the corneal surface)
- Visually significant (best-corrected visually acuity 20/100 or worse)
- total/near-total LSCD with recurrent erosions or PEDs (involving more than 75% of the limbus, or more than 75% of the corneal surface)
- Visually significant (best-corrected visually acuity 20/100 or worse) PLUS
- Persistent epithelial defects last >2 weeks despite maximal medical therapy OR
Key exclusion criteria (4 listed)
- Pregnant women
- Prisoners (vulnerable population)
- Adults lacking capacity to consent (vulnerable population)
- Adults unable to sign consent due to non-english speaking or illiterate (vulnerable population)
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 |
|---|---|---|
| transplantation of a Descemet's Membrane corneal onlay, partial LSCDThe worst seeing eye of these patients (or a randomized eye if vision is equal bilaterally) will be treated with superficial keratectomy to remove any pannus and debride the central corneal epithelium, followed by transplantation of a Descemet's membrane corneal onlay. Patient will be followed for 6 months and evaluated for improvement in visual acuity and improvement in limbal stem cell deficiency, and monitored for adverse events. | Procedure or surgery | Visually significant partial LSCD |
| transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCDThe worst seeing eye of these patients (or a randomized eye if vision is equal bilaterally) will be treated with superficial keratectomy to remove any pannus and debride the central corneal epithelium, followed by transplantation of a Descemet's membrane (DM) corneal onlay. Patient will be followed for 6 months and evaluated for improvement in visual acuity, limbal stem cell deficiency, and persistent epithelial defects/recurrent erosions, and monitored for adverse events. | Procedure or surgery | Total/near-total LSCD with recurrent or persistent epithelial defects (PED) |
Primary outcome
Visual improvement
Time frame: 180 days following intervention
Visual Acuity: Improvement in visual acuity over time will be measured as the difference in post-op visual acuity at post-operative week 1, month 1, month 3, and month 6 compared to pre-op visual acuity. Visual acuity will be assessed in study eyes with a standard Snellen Eye Chart.
Graft Retention on Slit Lamp Examination
Time frame: 180 days following intervention
Retention of the graft: Retention of the graft on the surface of the eye will be documented as present, absent, or indeterminant using slit lamp examination. For slit lamp examination, retention of the graft will be evidenced by visualization of a gentian violet orientation mark (s-stamp) that will be placed on all grafts at the time of tissue processing by the eye bank (prior to transplantation).
Graft Retention on Slit Lamp Photography.
Time frame: 180 days following intervention
Retention of the graft: In order to maintain photographic proof of the findings on slit lamp examination, slit lamp photography will also be taken. Study eyes will be photographed at the slit lamp at post-operative week 1, month 1, month 3, and month 6. Retention of the graft will be evidenced by visualization of a gentian violet orientation mark (s-stamp) that will be placed on all grafts at the time of tissue processing by the eye bank (prior to transplantation). This photographic documentation will assist in confirming the findings in outcome measure #2.
Incidence of Post-operative Adverse Events Requiring Treatment
Time frame: 180 days following intervention
Post-operative adverse events: Patients will be assessed at slit lamp at post-operative week 1, month 1, month 3, and month 6 for dislocation or opacification of the DM corneal onlay, PEDs, elevated intraocular pressure (IOP), and/or infectious keratitis to assess the safety of the therapy. Any persistent epithelial defect will be measured for size on slit lamp by recording the long and short diameter of any defect. IOP will be measured using a Goldman applanation. Infectious keratitis and membrane dislocation will be assessed at slit lamp during each post-operative visit.
Corneal Neovascularization on Slit Lamp Examination
Time frame: 180 days following intervention
Corneal Neovascularization: will be evaluated using slit lamp examination pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal neovascularization will be quantified using a previously established 10-point slit lamp examination score based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Corneal Neovascularization on Slit Lamp Photography
Time frame: 180 days following intervention
In order to maintain photographic proof of the findings on slit lamp examination, slit lamp photography will also be taken. Photos will be taken pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal neovascularization on the photos will be compared to the documented 10-point slit lamp examination score from outcomes measure #6 to confirm the accuracy of the results. Again, the 10-point slit lamp examination score is based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Corneal Epitheliopathy on Slit Lamp Examination
Time frame: 180 days following intervention
Corneal Epitheliopathy: will be evaluated using slit lamp examination pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal epitheliopathy will be quantified using a previously established 10-point slit lamp examination score based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Corneal Epitheliopathy on Slit Lamp Photography
Time frame: 180 days following intervention
In order to maintain photographic proof of the findings on slit lamp examination, slit lamp photography will also be taken. Photos will be taken pre-operatively and post-operatively at week 1, month 1, month 3, and month 6. The degree of corneal epitheliopathy on the photos will be compared to the documented 10-point slit lamp examination score from outcomes measure #8 to confirm the accuracy of the results. Again, the 10-point slit lamp examination score is based on the extent of limbal involvement (number of quadrants involved - up to 4 points), the extent of corneal surface involvement (total area of corneal involved - up to 4 points), and whether the central visual axis is involved (up to 2 points).
Corneal epithelial thickness
Time frame: 180 days following intervention
Corneal epithelial thickness will be assessed as a metric of LSCD severity. Corneal epithelial thickness will be measured in cross-section on AS-OCT only.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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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.
Stephen Kaufman, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transplantation of a Descemet's Membrane corneal onlay, partial LSCD and transplantation of a Descemet's Membrane corneal onlay, total/near-total LSCD in people with Limbal Stem-cell Deficiency and Congenital Aniridia, run by University of Minnesota 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 8 inclusion and 4 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 8 Jan 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual improvement (time frame: 180 days following intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.