KeratoconusNCT03504800
OCT in Diagnosis of Irregular Corneas
An observational study of Keratoconus and Corneal Opacity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. The primary goal will be achieved by using optical coherence tomography (OCT) to: 1. Read more about this study
- Who is it for?
- Ages 14 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Corneal Opacity, Corneal Dystrophy
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 28 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Show all 30Show fewer
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Humberto Martinez
Portland, Oregon, 97239
Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu
Denny Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas
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.
The primary goal will be achieved by using optical coherence tomography (OCT) to:
- Develop an OCT-based system to classify and evaluate corneal-shape irregularities.
- Develop OCT metrics for more sensitive detection of keratoconus progression.
- Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.
- Conditions
- Keratoconus, Corneal Opacity, Corneal Dystrophy
- Being tested
- Optical Coherence Tomography
- Keywords
- OCT, Keratoconus
- Medical subject headings
- Keratoconus, Corneal Opacity, Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 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. Receives: Device: 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. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Clinical classification of keratoconus, epithelial deformation, stromal addition/subtraction, stromal distortion, and healthy controls by OCT. Primary measurements will be corneal and epithelial thicknesses assessed in micron units.
Measured: 1 day
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Measured: 1 day
Develop OCT metrics for more sensitive detection of keratoconus progression
Primary measurements will be OCT corneal and epithelial thicknesses assessed in micron units.
Measured: 4 year
Develop OCT metrics for more sensitive detection of keratoconus progression
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Measured: 4 year
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
The primary goal is to improve the post-procedural outcome of uncorrected and best corrected visual acuity. This will be measured in feet by conventional Snellen fraction of 20/xx.
Measured: 1 year
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 May 2018
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 445 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Yan Li, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504800
- Sponsor's protocol ID
- IRB#000018036
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2018
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas
- ClinicalTrials.gov ID
- NCT03504800
- Acronym / sponsor ID
- IRB#000018036
- Conditions
- Keratoconus, Corneal Opacity, Corneal Dystrophy
- Keywords
- OCT, Keratoconus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 445 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The primary goal will be achieved by using optical coherence tomography (OCT) to:
- Develop an OCT-based system to classify and evaluate corneal-shape irregularities.
- Develop OCT metrics for more sensitive detection of keratoconus progression.
- Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Classification of Corneal Irregularities | – | Device: Optical Coherence TomographyThis 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. |
| Group B: Detection of Keratoconus Progression | – | Device: Optical Coherence TomographyParticipants 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. |
| Group C: OCT-and-Topography Guided PTK | – | Device: Optical Coherence TomographyParticipants 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. |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (30 listed)
- Keratoconus:
- Contact lens-related corneal warpage:
- Dry eye:
- Epithelial basement membrane dystrophy (EBMD):
- Stromal addition or subtraction:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyThis device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C. | Device | Group A: Classification of Corneal Irregularities, Group B: Detection of Keratoconus Progression, Group C: OCT-and-Topography Guided PTK |
Primary outcome
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Time frame: 1 day
Clinical classification of keratoconus, epithelial deformation, stromal addition/subtraction, stromal distortion, and healthy controls by OCT. Primary measurements will be corneal and epithelial thicknesses assessed in micron units.
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Time frame: 1 day
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Develop OCT metrics for more sensitive detection of keratoconus progression
Time frame: 4 year
Primary measurements will be OCT corneal and epithelial thicknesses assessed in micron units.
Develop OCT metrics for more sensitive detection of keratoconus progression
Time frame: 4 year
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
Time frame: 1 year
The primary goal is to improve the post-procedural outcome of uncorrected and best corrected visual acuity. This will be measured in feet by conventional Snellen fraction of 20/xx.
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
Time frame: 1 year
The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Li, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Corneal Opacity, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Humberto Martinez, COT (503-494-7712, martinhu@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop OCT-based system to classify and evaluate corneal-shape irregularities (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.