Actively Recruiting
PVEK Corneal Implant For Treatment of Corneal Edema
Led by Precise Bio · Updated on 2026-01-12
15
Participants Needed
3
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if PVEK, a corneal implant , is safe and well tolerated for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty. The main questions it aims to answer are: What side effects may happen after the PVEK implant? How many participants can complete the first 6 months after surgery without needing another treatment because the implant did not help enough or was not tolerable? This is a Phase 1 (first-in-human) study with one study group, meaning all participants receive the PVEK implant (there is no placebo or comparison group). About 15 participants will take part and will be followed for up to 12 months after surgery. Participants will: Complete screening tests (including eye exams and routine health checks) Have the PVEK implantation surgery Use prescribed eye drops after surgery Return for follow-up visits over the next 12 months for eye exams and tests (such as vision testing, eye pressure checks, and eye scans)
CONDITIONS
Official Title
PVEK Corneal Implant For Treatment of Corneal Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and/or pseudophakic bullous keratopathy
- Affected eye is pseudophakic
- Best corrected visual acuity in the study eye between 6/379 (1.8 logMAR) and 6/12 (0.3 logMAR)
- Central corneal thickness greater than 0.6 mm by OCT
You will not qualify if you...
- Study eye is phakic (natural lens present)
- Study eye is a single sight eye or fellow eye does not meet vision requirements
- Malpositioned intraocular lens in the study eye
- Prior eye surgery other than uncomplicated cataract surgery with stable, centered posterior chamber IOL
- Axial eye length below 21 mm or above 26 mm
- Other significant corneal disease beyond mild dry eye, prior keratoplasty, or significant corneal scarring/opacities
- Active ocular or eyelid infection or inflammation; active or prior herpetic ocular infection; uveitis
- Glaucoma or history/suspicion of elevated eye pressure; screening eye pressure above 23 mmHg
- Synechiae or abnormal anterior eye segment (e.g., aphakia, aniridia)
- Corneal endothelial cell density above 1000 cells/mm² or not reliably measurable
- Uncontrolled systemic medical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Ophthalmological Center After S.V.Malayan
Yerevan, Armenia, 0048
Not Yet Recruiting
2
Sharei Zedek Medical Center
Jerusalem, Jerusalem, Israel, abecassis
Not Yet Recruiting
3
Rambam Medical Center
Haifa, Israel, 3109602
Actively Recruiting
Research Team
A
Amos Eitan
CONTACT
L
Lior Rosenberg Belmaker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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