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

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.

NCT Number	NCT06818747
Lead Sponsor	Centre Hospitalier Régional Metz-Thionville
Conditions	Bullous Pseudophakic Keratopathy, Penetrating Keratoplasty
Enrollment	334 participants
Start Date	2025-05-21
Primary Completion	2027-05-21 (estimated)
Study Completion	2029-08-21 (estimated)
Updated on ClinicalTrials.gov	2026-06-24