Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

OCT in Diagnosis of Irregular Corneas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504800
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Tracking Information
First Submitted Date April 11, 2018
First Posted Date April 20, 2018
Last Update Posted Date March 15, 2019
Actual Study Start Date May 1, 2018
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: April 19, 2018)
  • OCT-based Classification of Corneal Irregularities [ Time Frame: 1 day ]
    Clinical classification of keratoconus, epithelial deformation, stromal addition/subtraction, stromal distortion, and healthy controls by OCT.
  • Detection of Keratoconus Progression by OCT [ Time Frame: 4 year ]
  • OCT-and-Topography Guided PTK [ Time Frame: 1 year ]
    OCT-and-Topography guided PTK treatment for participants with stromal addition/subtraction or stromal distortion.
Change History Complete list of historical versions of study NCT03504800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OCT in Diagnosis of Irregular Corneas
Official Title Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition
  • Keratoconus
  • Corneal Opacity
  • Corneal Dystrophy
Intervention Device: Optical Coherence Tomography
This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B & C.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Device: Optical Coherence Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 19, 2018)
445
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

GROUP A:

  • Keratoconus:

    1. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
    2. Topography characteristic of keratoconus or pellucid marginal degeneration
  • Contact lens-related corneal warpage:

    1. Contact lens use; and
    2. Topography irregularities
  • Dry eye:

    1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
    2. Topography irregularities
    3. Presence of punctate epithelial erosion on exam with surface staining
    4. Aqueous deficiency or evaporative dry eye
  • Epithelial basement membrane dystrophy (EBMD):

    1. Negative corneal fluorescein staining; and
    2. Corneal opacities; and
    3. Topography irregularities
  • Stromal addition or subtraction:

    1. Scars; or
    2. Salzmann's degeneration; or
    3. Stromal dystrophies; or
    4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)
  • Stromal distortion:

    1. Radial keratectomy (RK); or
    2. Corneal transplants.
  • Normal controls:

    1. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Omkar Thaware, B Optom, MSVS 503-494-7398 thaware@ohsu.edu
Contact: Denny Romfh, OD 503-494-4351 romfhd@ohsu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03504800
Other Study ID Numbers IRB#000018036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement Not Provided
Responsible Party David Huang, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Not Provided
Investigators
Principal Investigator: Yan Li, PhD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date March 2019