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

Study acronym: DESPEK
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Site details revised at 7 of 11 sitesv6
  3. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 10 to 11
    • Primary completion date: May 15, 2027 to May 21, 2027
    • Study completion date: Aug 15, 2029 to Aug 21, 2029
    • Start date changed from estimate of May 15, 2025 to May 21, 2025
  4. Study sites: 8 to 10
    • Primary completion date: May 1, 2027 to May 15, 2027
    • Study completion date: Aug 1, 2029 to Aug 15, 2029
    • Start date: May 1, 2025 to May 15, 2025
    v4
  5. Start date: Mar 1, 2025 to May 1, 2025
    • Primary completion date: Mar 1, 2027 to May 1, 2027
    • Study completion date: May 1, 2029 to Aug 1, 2029
    v3
  6. Secondary endpoints revised (15)
    • Study title shortened, about 11 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06818747
Lead Sponsor Centre Hospitalier Régional Metz-Thionville
Conditions
(from sponsor)		 Bullous Pseudophakic Keratopathy, Penetrating Keratoplasty
Enrollment 334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov