Comparative Effectiveness of PKP and DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced Bullous Pseudophakic Keratopathy: a Randomised Clinical Trial

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• The patient:

‣ Is ≥ 50 years old.

⁃ 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.

⁃ Is indicated for a corneal transplant.

⁃ Is pseudophakic.

⁃ Has provided free and informed written consent.

⁃ Is affiliated to a social security scheme.

⁃ Can be followed-up by the same investigating team during the study period.

Locations
Other Locations
France
CHU Besançon - Hôpital Jean Minjoz
NOT_YET_RECRUITING
Besançon
CHU Bordeaux - Hopital Pellegrin
NOT_YET_RECRUITING
Bordeaux
CHU Brest - Hopital Morvan
NOT_YET_RECRUITING
Brest
CHR Metz-Thionville Hopital de Mercy
RECRUITING
Metz
CHU Nantes - Hôpital Hotel-Dieu
NOT_YET_RECRUITING
Nantes
APHP - Hopital Cochin
NOT_YET_RECRUITING
Paris
Chno Xv Xx
NOT_YET_RECRUITING
Paris
CHU Saint-Etienne - Hôpital Nord
NOT_YET_RECRUITING
Saint-etienne
CHRU Strasbourg - Nouvel Hôpital Civil
NOT_YET_RECRUITING
Strasbourg
CHU Toulouse - Hopital Purpan
NOT_YET_RECRUITING
Toulouse
CHRU Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Arpiné EL NAR, PhD
projet-recherche-clinique@chr-metz-thionville.fr
0033387557766
Backup
Mélanie JUNKE
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2029-08-21
Participants
Target number of participants: 334
Treatments
Active_comparator: DSAEK
DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's diseased endothelium and overlying Descemet membrane with a corneal graft composed of endothelium, Descemet membrane, and a thin layer of overlying stroma.
Active_comparator: PKP
PKP (Penetrating Keratoplasty) involves removing a full-thickness central corneal disc from the diseased cornea and replacing it with an equivalent corneal disc from a deceased human donor.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Régional Metz-Thionville

This content was sourced from clinicaltrials.gov