BridgeMD
Compares treatment options for Bullous Pseudophakic Keratopathy
Official title Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
ClinicalTrials.gov ID: NCT06818747
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join 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...
- Is indicated for a corneal transplant.
- Is pseudophakic.
You likely can't join 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)...
- Has a contraindication to general anesthesia.
- Is deprived of freedom, or under a legal protective measure.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Brest, France
- Metz, France
- Nantes, France
- Paris, France
- Saint-Etienne, France
- Strasbourg, France
- Toulouse, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Brest, France; Metz, France; Nantes, France; Paris, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.