Condition: Bullous Pseudophakic Keratopathy · Penetrating Keratoplasty · Sponsor: Centre Hospitalier Régional Metz-Thionville
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.
This description comes directly from the study's public registry record.
Arpiné EL NAR, PhD · 0033387557766 · projet-recherche-clinique@chr-metz-thionville.fr
Mélanie JUNKE
Always discuss trial participation with your own doctor first.
| CHU Besançon - Hôpital Jean Minjoz | Besançon, France | Recruiting |
| CHU Bordeaux - Hopital Pellegrin | Bordeaux, France | Recruiting |
| CHU Brest - Hopital Morvan | Brest, France | Recruiting |
| CHR Metz-Thionville Hopital de Mercy | Metz, France | Recruiting |
| CHU Nantes - Hôpital Hotel-Dieu | Nantes, France | Not Yet Recruiting |
| APHP - Hopital Cochin | Paris, France | Not Yet Recruiting |
| Chno Xv Xx | Paris, France | Not Yet Recruiting |
| CHU Saint-Etienne - Hôpital Nord | Saint-Etienne, France | Recruiting |
| CHRU Strasbourg - Nouvel Hôpital Civil | Strasbourg, France | Recruiting |
| CHU Toulouse - Hopital Purpan | Toulouse, France | Recruiting |
| CHRU Tours | Tours, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06818747