NCT06818747 Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
| NCT ID | NCT06818747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional Metz-Thionville |
| Condition | Bullous Pseudophakic Keratopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2027-05-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2025-05-21 with a primary completion date of 2027-05-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * The patient: 1. Is ≥ 50 years old. 2. Has advanced PBK, with a best corrected visual acuity that lies between being able to see a hand move (i.e. 2 logMAR, included) and 2/10 excluded (i.e. 0.7 logMAR, excluded) and a central corneal thickness that exceeds 600 μm. 3. Is indicated for a corneal transplant. 4. Is pseudophakic. 5. Has provided free and informed written consent. 6. Is affiliated to a social security scheme. 7. Can be followed-up by the same investigating team during the study period. Exclusion Criteria: * The patient: 1. Has a history of corneal transplant on either eye (i.e. the study surgery will be the first corneal transplant for the patient). 2. Has an anterior chamber lens implant or is aphakic. 3. Has an ocular comorbidity that will impact visual acuity recovery: exudative or advanced atrophic AMD, advanced diabetic retinopathy (macular edema), advanced glaucoma (damage to the central visual field), important sequelae of central venous thrombosis of the retina or retinal detachment, previous amblyopia. 4. Has a contraindication to general anesthesia. 5. Is deprived of freedom, or under a legal protective measure. 6. Is included in another clinical study. 7. Has a severe general condition that might lead to premature discontinuation of the trial before the end of treatment period.
Contact & Investigator
Jean-Marc PERONE, MD
PRINCIPAL INVESTIGATOR
CHR Metz Thionville Hopital de Mercy
Frequently Asked Questions
Who can join the NCT06818747 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Bullous Pseudophakic Keratopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06818747 currently recruiting?
Yes, NCT06818747 is actively recruiting participants. Contact the research team at projet-recherche-clinique@chr-metz-thionville.fr for enrollment information.
Where is the NCT06818747 trial being conducted?
This trial is being conducted at Besançon, France, Bordeaux, France, Brest, France, Metz, France and 7 additional locations.
Who is sponsoring the NCT06818747 clinical trial?
NCT06818747 is sponsored by Centre Hospitalier Régional Metz-Thionville. The principal investigator is Jean-Marc PERONE, MD at CHR Metz Thionville Hopital de Mercy. The trial plans to enroll 334 participants.