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

Condition(s) studied

Investigational drug(s) / intervention(s)

Best corrected monocular visual acuity: Assessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation

Study 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.

Eligibility

Primary outcome measure(s)

• DSAEK and PKP comparison in terms of visual acuity — At 24 postoperative months
  Best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)

Trial sites (11)

More Centre Hospitalier Régional Metz-Thionville trials in France