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NCT06818747: DESPEK

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

Recruiting now NA Last updated 28 May 2025
What this trial tests

NA trial testing Best corrected monocular visual acuity in Bullous Pseudophakic Keratopathy in 334 participants. Currently enrolling.

Timeline
21 May 2025
Primary endpoint
21 May 2027
21 August 2029

Quick facts

Lead sponsorCentre Hospitalier Régional Metz-Thionville
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment334
Start date21 May 2025
Primary completion21 May 2027
Estimated completion21 August 2029
Sites11 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Régional Metz-Thionville

Who can join

50 and older, any sex, with Bullous Pseudophakic Keratopathy or Penetrating Keratoplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Centre Hospitalier Régional Metz-Thionville trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06818747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing