Actively Recruiting
Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
Led by Oregon Health and Science University · Updated on 2025-09-09
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to use optical coherence tomography (OCT) technology to measure corneal swelling, also called corneal edema, in people with Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy. The study aims to predict changes in vision that may occur as the swelling resolves after surgical treatments. This study is sponsored by Oregon Health and Science University and focuses on understanding corneal changes over time in these eye conditions. The study includes two groups: one group of adults 18 years or older with these conditions who do not need surgery according to standard care, and another group of adults who do require surgery such as Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO). The surgery decisions are made by the attending physician following usual care guidelines. The study does not assign or pay for treatments. Participants will be followed for up to two years, during which OCT imaging will be used to evaluate the corneal epithelial and stromal edema or haze. Researchers will monitor changes in the cornea and vision after treatment or during observation. Participants must commit to attending required study visits. The study does not involve additional treatments but focuses on imaging and clinical assessments to better understand corneal health and vision changes in these eye conditions.
CONDITIONS
Brief Title
OCT in Fuchs' Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Damaged or diseased corneal endothelium from Fuchs' dystrophy or pseudophakic bullous keratopathy
- Willingness to commit to required study visits
- Adults aged 18 years or older
You will not qualify if you...
- Prior endothelial keratoplasty or any other surgery except uncomplicated cataract surgery
- Presence of conditions increasing risk of treatment failure, such as heavily vascularized cornea or uncontrolled uveitis
- Other primary endothelial dysfunction conditions like posterior polymorphous corneal dystrophy or iridocorneal endothelial syndrome
- Central sub-epithelial or stromal scarring affecting post-operative clarity assessment
- Peripheral anterior synechiae in the angle greater than 3 clock hours
- Hypotony
- Uncontrolled glaucoma
- Visually significant optic nerve or macular pathology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants who do not require surgery are observed over time to monitor corneal edema and haze.
Periodic visits for monitoring
Duration - Per standard-of-care guidelines
Participants who require surgery undergo Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO) surgery followed by immediate post-operative care.
Visits as per routine post-surgical care
Duration - Up to 2 years
Participants who undergo surgery are followed for up to 2 years to monitor corneal edema and haze after the intervention.
Periodic follow-up visits
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
H
Humberto Martinez, COT
D
Denzil Romfh, OD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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