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RECRUITING
NCT06818747
NA

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

Sponsor: Centre Hospitalier Régional Metz-Thionville

View on ClinicalTrials.gov

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

PROCEDURE

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