Comparing two surgical methods for treating advanced bullous pseudophakic keratopathy

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

This study is testing whether two different eye surgeries can help people over 50 with advanced bullous pseudophakic keratopathy see better and feel more satisfied after the procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 334 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Régional Metz-Thionville (Academic / other)
• Locations: 11 sites (Besançon and 10 other locations)
• Trial ID: NCT06818747 on ClinicalTrials.gov

What this trial studies

This clinical trial is an open-label, multicenter, randomized controlled trial designed to compare the effectiveness of Penetrating Keratoplasty (PKP) versus Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) in patients with advanced Bullous Pseudophakic Keratopathy (PBK). Eligible patients aged 50 and older will be randomized into one of the two surgical arms, and their visual acuity, quality of life, patient satisfaction, pain levels, and corneal thickness will be assessed at multiple follow-up visits over a two-year period. The study aims to determine which surgical method provides better postoperative visual outcomes and overall patient satisfaction.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 50 and older with advanced PBK and specific visual acuity criteria.

Not a fit: Patients with a history of corneal transplant or significant ocular comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved visual outcomes and quality of life for patients suffering from advanced bullous pseudophakic keratopathy.

How similar studies have performed: Previous studies have shown that DSAEK often results in faster visual recovery and fewer complications compared to PKP, indicating a potential for success in this comparative approach.

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.

Where this trial is running

Besançon and 10 other locations

• CHU Besançon - Hôpital Jean Minjoz — Besançon, France (Not_yet_recruiting)
• CHU Bordeaux - Hopital Pellegrin — Bordeaux, France (Not_yet_recruiting)
• CHU Brest - Hopital Morvan — Brest, France (Not_yet_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 (Not_yet_recruiting)
• CHRU Strasbourg - Nouvel Hôpital Civil — Strasbourg, France (Not_yet_recruiting)
• CHU Toulouse - Hopital Purpan — Toulouse, France (Not_yet_recruiting)
• CHRU Tours — Tours, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Jean-Marc PERONE, MD — CHR Metz Thionville Hopital de Mercy
• Study coordinator: Arpiné EL NAR, PhD

Conditions Bullous Pseudophakic Keratopathy; Penetrating Keratoplasty; Best corrected monocular visual acuity; Quality of life