NCT03504800 · Oregon Health and Science University
OCT in Diagnosis of Irregular Corneas
What this study is about
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. Develop an OCT-based system to classify and evaluate corneal-shape irregularities. 2.
View original scientific description
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. 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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:
- 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.
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.
Where
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations