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

Launched by CENTRE HOSPITALIER RÉGIONAL METZ-THIONVILLE · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two types of surgeries for patients with a condition called Bullous Pseudophakic Keratopathy (BPK), which affects vision after cataract surgery. The two surgical methods being compared are Penetrating Keratoplasty (PKP) and Descemet Stripping Automated Endothelial Keratoplasty (DSAEK). The goal is to see which surgery provides better vision improvement over two years. Patients who are 50 years or older, have advanced BPK, and are eligible for a corneal transplant may participate in this study.

If you join the trial, you will be randomly assigned to one of the two surgeries, and your vision, satisfaction, pain levels, and quality of life will be monitored over the next two years. You will have several follow-up visits where doctors will check your vision and overall health. This trial is not yet recruiting, so if you think you might qualify, keep an eye out for updates on when it begins. Your participation could help improve treatment options for people with similar eye problems in the future.

Gender

ALL

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.