Actively Recruiting
Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2025-05-28
334
Participants Needed
11
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of PKP vs DSAEK in Terms of 2-year Postoperative Visual Acuity in Advanced BPK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 50 years old or older
- Has advanced Bullous Pseudophakic Keratopathy with best corrected visual acuity between seeing hand movements (2 logMAR, included) and 2/10 (0.7 logMAR, excluded) and central corneal thickness over 600 bcm
- Is indicated for a corneal transplant
- Is pseudophakic
- Has provided free and informed written consent
- Is affiliated with a social security scheme
- Can be followed-up by the same investigating team throughout the study
You will not qualify if you...
- Has history of corneal transplant on either eye; this study surgery must be their first corneal transplant
- Has an anterior chamber lens implant or is aphakic
- Has ocular conditions impacting visual recovery such as advanced age-related macular degeneration, advanced diabetic retinopathy, advanced glaucoma, retinal vein thrombosis sequelae, retinal detachment, or previous amblyopia
- Has a contraindication to general anesthesia
- Is deprived of freedom or under legal protective measures
- Is currently enrolled in another clinical study
- Has a severe general health condition that might cause early trial discontinuation
AI-Screening
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Trial Site Locations
Total: 11 locations
1
CHU Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
Not Yet Recruiting
2
CHU Bordeaux - Hopital Pellegrin
Bordeaux, France, 33076
Not Yet Recruiting
3
CHU Brest - Hopital Morvan
Brest, France, 29609
Not Yet Recruiting
4
CHR Metz-Thionville Hopital de Mercy
Metz, France, 57085
Actively Recruiting
5
CHU Nantes - Hôpital Hotel-Dieu
Nantes, France, 44000
Not Yet Recruiting
6
APHP - Hopital Cochin
Paris, France, 75014
Not Yet Recruiting
7
Chno Xv Xx
Paris, France, 75571
Not Yet Recruiting
8
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, France, 42055
Not Yet Recruiting
9
CHRU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Not Yet Recruiting
10
CHU Toulouse - Hopital Purpan
Toulouse, France, 31059
Not Yet Recruiting
11
CHRU Tours
Tours, France, 37044
Not Yet Recruiting
Research Team
A
Arpiné EL NAR, PhD
CONTACT
M
Mélanie JUNKE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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