Actively Recruiting

Age: 18Years +
All Genders
ID04258787

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surveillance

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

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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