PVEK corneal implant to treat corneal swelling

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 Phase 1, first‑in‑human, open‑label study will implant a Precise Vision Endothelial Keratoplasty (PVEK) device in about 15 participants with corneal edema due to Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy. All participants receive the PVEK implant (single‑arm) and will use prescribed postoperative eye drops with no placebo or comparator group. The study focuses on safety and tolerability, monitoring side effects and measuring how many participants complete the first six months without needing another treatment. Participants undergo screening, the implantation surgery, and scheduled follow-up visits including eye exams and OCT over a 12‑month period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

age 18/50 years or older

Corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and/or pseudophakic bullous keratopathy

Pseudophakic study eye

Best corrected visual acuity (BCVA) 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

Exclusion Criteria:

Phakic study eye

Study eye is a "single sight eye" (per protocol definition) / fellow eye does not meet protocol vision requirement

Malpositioned intraocular lens (dislocation/subluxation) in the study eye

Prior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL

Axial length below 21 mm or above 26 mm

Other significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring/opacities not expected to improve with treatment

Active ocular or eyelid infection/inflammation; active/prior herpetic ocular infection; uveitis

Glaucoma / history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye)

Synechiae; abnormal anterior segment (e.g., aphakia, aniridia)

Corneal endothelial cell density above 1000 cells/mm² at screening (or not reliably measurable)

Uncontrolled systemic conditions

Where it's running

• Rambam Medical Center
  Haifa, Israel Recruiting
• Ophthalmological Center After S.V.Malayan
  Yerevan, Armenia Not yet recruiting
• Sharei Zedek Medical Center
  Jerusalem, Jerusalem, Israel Not yet recruiting

Study contacts

• Principal investigator: Michael Minouni, Prof. — Rambam Health Care Campus
• Study coordinator: Amos Eitan
• Email: amos.eitan@precise-bio.com
• Phone: +972 54 7854387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using Terahertz Scanning to Evaluate Corneal Scars and Edema

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• Understanding Fuchs' Endothelial Corneal Dystrophy and its Genetic Links

  This study is trying to understand how Fuchs' Endothelial Corneal Dystrophy affects younger people with a genetic link to the condition by using advanced imaging to track changes over time.

  Recruiting University College, London · London · NCT06881771

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.