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New treatment option for Corneal Edema
Official title PVEK Corneal Implant For Treatment of Corneal Edema
ClinicalTrials.gov ID: NCT07325097
What this study is testing
What is Precise Vision Endothelial Keratoplasty (PVEK) Implant?
Precise Vision Endothelial Keratoplasty (PVEK) Implant is an investigational medicine, being studied as a potential treatment for corneal edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Yerevan, Armenia
- Jerusalem, Jerusalem, Israel
- Haifa, Israel
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yerevan, Armenia; Jerusalem, Jerusalem, Israel; Haifa, Israel. 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.