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Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK

RecruitingNAAges 50 Years - anyAllCentre Hospitalier Régional Metz-Thionville
NCT06818747 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an open-label multicenter randomised controlled clinical trial with 2 parallel arms with a 1:1 ratio. Patients meeting the eligibility criteria will be offered to participate in the study during an ophthalmology consultation. If they agree, they are randomised into one of the 2 arms, surgery is scheduled, and baseline visual acuity, quality of life, patient satisfaction, pain level, and central corneal thickness are recorded (inclusion visit). The following visits involve: the corneal transplant procedure (DSAEK or PKP depending on the randomisation) and follow-up visits at 1, 6, 12, and 24 months. At each visit, visual acuity, patient satisfaction, pain level and complications will be determined. At 6, 12, and 24 months, endothelial cell density, central corneal thickness and required optical correction will be measured. At 12 and 24 months, quality of life, will also be determi

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📋 Eligibility rules (as published)
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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What it tests

  • Best corrected monocular visual acuity
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Where

11 sites
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Bordeaux - Hopital Pellegrin
Bordeaux, France
CHU Brest - Hopital Morvan
Brest, France
CHR Metz-Thionville Hopital de Mercy
Metz, France
CHU Nantes - Hôpital Hotel-Dieu
Nantes, France
APHP - Hopital Cochin
Paris, France
Chno Xv Xx
Paris, France
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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