Comparing two surgical methods for treating advanced bullous pseudophakic keratopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Besançon - Hôpital Jean Minjoz
  Besançon, France Recruiting
• CHU Bordeaux - Hopital Pellegrin
  Bordeaux, France Recruiting
• CHU Brest - Hopital Morvan
  Brest, France Recruiting
• CHR Metz-Thionville Hopital de Mercy
  Metz, France Recruiting
• CHU Saint-Etienne - Hôpital Nord
  Saint-Etienne, France Recruiting
• CHRU Strasbourg - Nouvel Hôpital Civil
  Strasbourg, France Recruiting

Study contacts

• Principal investigator: Jean-Marc PERONE, MD — CHR Metz Thionville Hopital de Mercy
• Study coordinator: Arpiné EL NAR, PhD
• Email: projet-recherche-clinique@chr-metz-thionville.fr
• Phone: 0033387557766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.