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New eye scanner could sharpen diagnosis of corneal problems

NCT ID NCT03504800

Diagnosis Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study aims to improve how doctors detect, classify, and treat irregular corneas caused by conditions like keratoconus, dry eye, and corneal scars. Researchers will use a special imaging device called optical coherence tomography (OCT) to get detailed measurements of the cornea. The study involves 445 participants and will also test a new OCT-guided laser treatment to improve vision. The goal is to make diagnosis more accurate and treatments more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Optical coherence tomography (OCT) device
What this could lead to
If successful, this could improve how doctors diagnose and treat irregular corneas, leading to better vision outcomes for patients.
What could go wrong
This is an early-stage study focused on developing and testing new diagnostic methods, not a treatment trial. The new techniques may not prove better than current approaches.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 445 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 445 participants ages 14 or older will be recruited for the 3 clinical studies. All 3 studies will be performed at the Casey Eye Institute at Oregon Health \& Science University. Group A: * Keratoconus: 150 participants * Epithelial deformation: 105 participants; This category includes contact lens-related corneal warpage, dry eye, and EBMD. * Primary stromal changes: 100 participants; This category includes corneal scars, Salzmann's degeneration, stromal dystrophies, complicated LASIK/PRK cases with visual complaints, RK cases, and corneal transplants. * Healthy Controls: 90 participants

Ages

14 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: GROUP A: * Keratoconus: 1. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye 2. Topography characteristic of keratoconus or pellucid marginal degeneration * Contact lens-related corneal warpage: 1. Contact lens use; and 2. Topography irregularities * Dry eye: 1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and 2. Topography irregularities 3. Presence of punctate epithelial erosion on exam with surface staining 4. Aqueous deficiency or evaporative dry eye * Epithelial basement membrane dystrophy (EBMD): 1. Negative corneal fluorescein staining; and 2. Corneal opacities; and 3. Topography irregularities * Stromal addition or subtraction: 1. Scars; or 2. Salzmann's degeneration; or 3. Stromal dystrophies; or 4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK) * Stromal distortion: 1. Radial keratectomy (RK); or 2. Corneal transplants. * Normal controls: 1. Healthy eyes with no previous eye procedures/surgeries. GROUP B: Participants will be selected from the keratoconus population in Group A based on topography findings. GROUP C: Participants will be selected from the stromal addition/subtraction and stromal distortion populations of Group A if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from PTK. Exclusion Criteria (all groups): * Inability to give informed consent. * Inability to maintain fixation for OCT imaging. * Inability to commit to required study visits. * Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery. * Previous corneal surgeries if considered as a keratoconus participant. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

corneal degeneration corneal dystrophy Corneal Opacity dry eye syndrome epithelial basement membrane dystrophy keratoconus pellucid marginal degeneration stromal corneal dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corneal dystrophy Corneal opacity Keratoconus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Humberto Martinez

    RECRUITING

    Portland, Oregon, 97239, United States

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