Taking people in United StatesNo phase

Eye scans to better assess irregular corneas, including keratoconus

Tests optical coherence tomography eye imaging in people with keratoconus and other irregular corneas.

Key facts

Who runs it: Oregon Health and Science University
Where: Portland, United StatesSee the site
Trial code: NCT03504800
Registry title: OCT in Diagnosis of Irregular Corneas
Status: Recruiting
People taking part: 445 people, planned
Started: 1 May 2018
Expected to end: 28 Feb 2031
Type of study: Observational, 3 groups
Treatments tested: Optical Coherence Tomography
Record updated: 9 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with an irregular cornea, such as keratoconus, warpage from contact lenses, dry eye, scars or corneal dystrophies. People with healthy eyes can also join as controls.

Age: 14 Years to 85 Years
Sex: All sexes
Disease stage: Irregular corneal shape seen on corneal mapping (topography). This can come from keratoconus, pellucid marginal degeneration, contact lens warpage, dry eye with an OSDI score ≥ 30, EBMD, scars, Salzmann's degeneration, stromal dystrophies, problems after LASIK or PRK, RK or a corneal transplant. People with keratoconus need CDVA ≥ 20/25 in the better eye. Some people may join a group followed over time or a group treated with PTK.
Earlier treatment: People in the keratoconus group cannot have had corneal surgery before. Healthy controls must have had no earlier eye procedures or surgeries.

Main reasons for not taking part

Unable to give informed consent or come to the study visits
Unable to keep the eye still for OCT imaging
Cataract, retinal disease, glaucoma or other eye conditions that may limit vision after surgery
Pregnancy or breastfeeding
Earlier corneal surgery for people in the keratoconus group

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

GROUP A:
Keratoconus:; CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye; Topography characteristic of keratoconus or pellucid marginal degeneration
Contact lens-related corneal warpage:; Contact lens use; and; Topography irregularities
Dry eye:; Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and; Topography irregularities; Presence of punctate epithelial erosion on exam with surface staining; Aqueous deficiency or evaporative dry eye
Epithelial basement membrane dystrophy (EBMD):; Negative corneal fluorescein staining; and; Corneal opacities; and; Topography irregularities
Stromal addition or subtraction:; Scars; or; Salzmann's degeneration; or; Stromal dystrophies; or; Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)
Stromal distortion:; Radial keratectomy (RK); or; Corneal transplants
Normal controls:; 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

Who cannot take part

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
Inability to give informed consent
Inability to maintain fixation for OCT imaging
Inability to commit to required study visits
Pregnancy or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 14 and 85 years old?

Where in United States

Humberto MartinezPortland, United StatesContact: Humberto Martinez, COTTaking people

About the trial

What the trial wants to find out

This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions.

Read full original descriptionShow less

The primary goal will be achieved by using optical coherence tomography (OCT) to:

1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities. 2. Develop OCT metrics for more sensitive detection of keratoconus progression. 3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.

The 3 groups in the trial

Group A: Classification of Corneal Irregularities
This group will consist of participants \>14 years old with various types of corneal irregularities. Their data will be compared against participants with healthy corneas. Data for this group will be gathered only once.
Treatment: Optical Coherence Tomography
Group B: Detection of Keratoconus Progression
Participants from Group A who are diagnosed with keratoconus will be selected for this longitudinal study to monitor keratoconus progression. They will be followed up to 4 years.
Treatment: Optical Coherence Tomography
Group C: OCT-and-Topography Guided PTK
Participants from Group A will be selected for this group if they have vision primarily limited by scars, dystrophy, or high astigmatism that could be treated by PTK. They will be followed up to 1 year.
Treatment: Optical Coherence Tomography