Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 85
Healthy Volunteers: t
View:

∙ 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.

Locations
United States
Oregon
Humberto Martinez
RECRUITING
Portland
Contact Information
Primary
Humberto Martinez, COT
martinhu@ohsu.edu
503-494-7712
Backup
Denny Romfh, OD
romfhd@ohsu.edu
503-494-4351
Time Frame
Start Date: 2018-05-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 445
Treatments
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.
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.
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov