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Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
Sponsor: Centre Hospitalier Régional Metz-Thionville
Summary
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 determined.
Official title: Comparative Effectiveness of PKP and DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced Bullous Pseudophakic Keratopathy: a Randomised Clinical Trial
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2025-05-21
Completion Date
2029-08-21
Last Updated
2025-05-28
Healthy Volunteers
No
Interventions
Best corrected monocular visual acuity
Assessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation
Locations (11)
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
CHRU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
CHU Toulouse - Hopital Purpan
Toulouse, France
CHRU Tours
Tours, France