What this study is
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.
What's being tested
- Optical Coherence Tomography
Intervention · DEVICE
This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.
Study details
- Official title
- Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas
- Sponsor
- Oregon Health and Science University
- Conditions
- Keratoconus · Corneal Opacity · Corneal Dystrophy
- Enrolling
- 445 people
- Starts
- 2018-05-01
- Est. completion
- 2031-02-28
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 14 Years – 85 YearsSex ALLHealthy volunteers AcceptedGROUP A
You may qualify if
- 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.
You can't join if
- 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.
GROUP B
You may qualify if
- Participants will be selected from the keratoconus population in Group A based on topography findings.
You can't join if
- 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.
GROUP C
You may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHumberto Martinez
Portland, Oregon, United States
- Humberto Martinez, COT · Contact503-494-7712martinhu@ohsu.edu
- Denny Romfh, OD · Contact503-494-4351romfhd@ohsu.edu
- David Huang, MD, PhD · Sub-investigator
- Winston Chamberlain, MD, PhD · Sub-investigator
- Richard Stutzman, MD · Sub-investigator
- Afshan Nanji, MD · Sub-investigator
- Ellen Davis, MD · Sub-investigator
- Seema Gupta, MD · Sub-investigator
Recruiting
Study team
Sponsor
Oregon Health and Science University
Study ID IRB#000018036
Principal investigator
Yan Li, PhD
Oregon Health and Science University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.