Last reviewed · How we verify
NCT06818747: DESPEK
Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
NA trial testing Best corrected monocular visual acuity in Bullous Pseudophakic Keratopathy in 334 participants. Currently enrolling.
21 May 2027
Quick facts
| Lead sponsor | Centre Hospitalier Régional Metz-Thionville |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 334 |
| Start date | 21 May 2025 |
| Primary completion | 21 May 2027 |
| Estimated completion | 21 August 2029 |
| Sites | 11 locations across France |
Drugs / interventions tested
- Best corrected monocular visual acuity
Conditions studied
- Bullous Pseudophakic Keratopathy — all drugs for Bullous Pseudophakic Keratopathy →
- Penetrating Keratoplasty — all drugs for Penetrating Keratoplasty →
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.
Verify or expand the search:
- PubMed search for NCT06818747
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06818747 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Régional Metz-Thionville
- Last refreshed: 28 May 2025
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