Eye transplant showdown: which corneal procedure gives better vision?
NCT ID NCT06818747
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of corneal transplants—PKP and DSAEK—in 334 adults aged 50+ with advanced bullous pseudophakic keratopathy, a condition where the cornea swells and blurs vision. Participants are randomly assigned to one procedure and followed for 2 years to see which provides better visual acuity. The goal is to identify the more effective surgical option for restoring sight.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Corneal transplant procedure (either PKP or DSAEK)
- What this could lead to
- If this trial succeeds, it could show which corneal transplant method gives better vision recovery for people with advanced bullous keratopathy.
- What could go wrong
- This is a comparative effectiveness trial, not a test of a new drug. Results may not apply to all patients, and both procedures carry risks like graft rejection or infection.
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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About 334 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- 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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50 years and older
- 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.
Inclusion Criteria: * The patient: 1. Is ≥ 50 years old. 2. Has advanced PBK, with a best corrected visual acuity that lies between being able to see a hand move (i.e. 2 logMAR, included) and 2/10 excluded (i.e. 0.7 logMAR, excluded) and a central corneal thickness that exceeds 600 μm. 3. Is indicated for a corneal transplant. 4. Is pseudophakic. 5. Has provided free and informed written consent. 6. Is affiliated to a social security scheme. 7. Can be followed-up by the same investigating team during the study period. Exclusion Criteria: * The patient: 1. Has a history of corneal transplant on either eye (i.e. the study surgery will be the first corneal transplant for the patient). 2. Has an anterior chamber lens implant or is aphakic. 3. Has an ocular comorbidity that will impact visual acuity recovery: exudative or advanced atrophic AMD, advanced diabetic retinopathy (macular edema), advanced glaucoma (damage to the central visual field), important sequelae of central venous thrombosis of the retina or retinal detachment, previous amblyopia. 4. Has a contraindication to general anesthesia. 5. Is deprived of freedom, or under a legal protective measure. 6. Is included in another clinical study. 7. Has a severe general condition that might lead to premature discontinuation of the trial before the end of treatment period.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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APHP - Hopital Cochin
NOT_YET_RECRUITINGParis, 75014, France
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CHR Metz-Thionville Hopital de Mercy
RECRUITINGMetz, 57085, France
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CHRU Strasbourg - Nouvel Hôpital Civil
RECRUITINGStrasbourg, 67091, France
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CHRU Tours
RECRUITINGTours, 37044, France
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CHU Besançon - Hôpital Jean Minjoz
RECRUITINGBesançon, 25030, France
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CHU Bordeaux - Hopital Pellegrin
RECRUITINGBordeaux, 33076, France
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CHU Brest - Hopital Morvan
RECRUITINGBrest, 29609, France
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CHU Nantes - Hôpital Hotel-Dieu
NOT_YET_RECRUITINGNantes, 44000, France
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CHU Saint-Etienne - Hôpital Nord
RECRUITINGSaint-Etienne, 42055, France
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CHU Toulouse - Hopital Purpan
RECRUITINGToulouse, 31059, France
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Chno Xv Xx
NOT_YET_RECRUITINGParis, 75571, France
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