Does donor diabetes impact corneal transplant outcomes?
NCT ID NCT05134480
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study looked at whether diabetes in a cornea donor affects the success of a corneal transplant called DMEK. Over 1,000 participants received a cornea from either a donor with or without diabetes. Researchers tracked graft failure and cell loss for one year to see if donor diabetes plays a role.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors choose better cornea donors for transplant patients, potentially improving transplant success rates.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find a clear link between donor diabetes and transplant outcomes, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,097 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Participant Inclusion Criteria: 1. Age range 30- \< 91 years with minimum life expectancy of at least 1 year 2. Willingness to return to study site for follow up at 1 month and 1 year 3. Fluent in English or Spanish 4. Willingness to have fingerstick blood sample collected to determine HbA1c level at entry and at 1 year. The participant must agree to have their primary care provider contacted (or an appropriate referral provided) if they were not known to have diabetes and the HbA1c suggests they may have diabetes. Similarly, if already known to have diabetes and the HbA1c is high, the participant must agree to have their primary care provider contacted or an appropriate referral provided. 5. Has at least one eye clinically recommended for Descemet membrane endothelial keratoplasty (DMEK) that is able to be scheduled for DMEK between 5 to 90 days after enrollment. If second eye is enrolled, it must be scheduled for DMEK between 7 days and 6 months after DMEK on the first eye. 6. Has a condition related to endothelial dysfunction which will be treated by DMEK. Eligible indications for DMEK include: 1. Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following: phakic FECD with or without cataract (triple procedure including DMEK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed) 2. pseudophakic FECD with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL 3. pseudophakic corneal edema with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL without FECD 4. failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK originally performed for the same indications above without current exclusionary criteria, as described below Exclusion Criteria: 1. Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report. 2. Lack cognitive capacity such that consent could not be provided. 3. Presence of a condition that has a high probability for failure (e.g., failed penetrating keratoplasty, uncontrolled uveitis) 4. Stromal vascularization that will impede assessment of recipient stroma clarity 5. Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy. 6. Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal dystrophies and scars) 7. Aphakic corneal edema with or without FECD 8. Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior chamber IOL during DMEK 9. Presence of vitreous in the anterior chamber 10. Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study DMEK 11. Pre-operative central sub-epithelial or stromal scarring that could impact post-operative recipient stromal clarity assessment 12. Presence of anterior synechiae 13. Peripheral anterior synechiae in the angle greater than a total of three clock hours 14. Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement, or MIGS. Uncontrolled glaucoma is defined as intraocular pressure \> 25mm Hg. 15. Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with minimally invasive glaucoma surgery (MIGS) or trabeculectomy is allowed) 16. Fellow eye visual acuity \< 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK 17. Intraocular pressure \<8 mmHg 18. Topical Rho kinase inhibitor, including netarsudil, used within 1 month prior to study entry and anticipated during the course of the study 19. Fellow eye enrolled in the DEKS that has met study-criteria for graft failure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Price Vision Group
Indianapolis, Indiana, 46260, United States
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Verdier Eye Center
Grand Rapids, Michigan, 49546, United States
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Other studies related to the condition(s) this trial covers.
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