Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
Comparative Effectiveness of PKP and DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced Bullous Pseudophakic Keratopathy: a Randomised Clinical Trial
Centre Hospitalier Régional Metz-Thionville
334 participants
May 21, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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.
Exclusion Criteria8
- 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.
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Interventions
Assessed with the Monoyer scale and expressed in logMAR at 24 months after corneal transplantation
Locations(11)
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NCT06818747