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

NCT06818747 | Recruiting

• 1 other identifier: 2024-03-CHRMT
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 11

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.

Conditions

Bullous Pseudophakic Keratopathy; Penetrating Keratoplasty

Keywords

Best corrected monocular visual acuity; Quality of life

Outcome Measures

Primary Outcomes (1)

• DSAEK and PKP comparison in terms of visual acuity

  Best corrected monocular visual acuity (assessed with the Monoyer scale and expressed in logMAR)

  At 24 postoperative months

Secondary Outcomes (15)

• Visual acuity

  at 6, 12, and 24 postoperative months (repeated measures model)

• Time taken to achieve a postoperative best corrected visual acuity of at least 4/10 (0.4 logMAR).

  up to 24 postoperative months

• Percentage of patients achieving at least 4/10 (0.4 logMAR)

  up to 24 postoperative months

• Frequency of cases who require a regraft

  up to 24 postoperative months

• Change in quality of life at 12 and 24 months relative to preoperative baseline

  1 to 6 months before surgery and at 12 and 24 postoperative months

Study Arms (2)

DSAEK

ACTIVE COMPARATOR

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.

Procedure: Best corrected monocular visual acuity

PKP

ACTIVE COMPARATOR

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.

Procedure: Best corrected monocular visual acuity

Interventions

Best corrected monocular visual acuity PROCEDURE

Assessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation

DSAEK; PKP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient:
• Has a history of corneal transplant on either eye (i.e. the study surgery will be the first corneal transplant for the patient).
• Has an anterior chamber lens implant or is aphakic.
• 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.
• Has a contraindication to general anesthesia.
• Is deprived of freedom, or under a legal protective measure.
• Is included in another clinical study.
• Has a severe general condition that might lead to premature discontinuation of the trial before the end of treatment period.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (11)

CHU Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

NOT YET RECRUITING

CHU Bordeaux - Hopital Pellegrin

Bordeaux, 33076, France

NOT YET RECRUITING

CHU Brest - Hopital Morvan

Brest, 29609, France

NOT YET RECRUITING

CHR Metz-Thionville Hopital de Mercy

Metz, 57085, France

RECRUITING

CHU Nantes - Hôpital Hotel-Dieu

Nantes, 44000, France

NOT YET RECRUITING

APHP - Hopital Cochin

Paris, 75014, France

NOT YET RECRUITING

Chno Xv Xx

Paris, 75571, France

NOT YET RECRUITING

CHU Saint-Etienne - Hôpital Nord

Saint-Etienne, 42055, France

NOT YET RECRUITING

CHRU Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67091, France

NOT YET RECRUITING

CHU Toulouse - Hopital Purpan

Toulouse, 31059, France

NOT YET RECRUITING

CHRU Tours

Tours, 37044, France

NOT YET RECRUITING

Study Officials

• Jean-Marc PERONE, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Mélanie JUNKE

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: February 10, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): May 21, 2027
• Study Completion (Estimated): August 21, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)