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OCT in Diagnosis of Irregular Corneas

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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

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.

Condition or disease Intervention/treatment
Keratoconus Corneal Opacity Corneal Dystrophy Device: Optical Coherence Tomography

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Study Type : Observational
Estimated Enrollment : 445 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504800


Contacts
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Contact: Omkar Thaware, B Optom, MSVS 503-494-7398 thaware@ohsu.edu
Contact: Denny Romfh, OD 503-494-4351 romfhd@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Omkar Thaware, B Optom, MSVS    503-494-7398    thaware@ohsu.edu   
Contact: Denny Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Principal Investigator: Maolong Tang, PhD         
Sub-Investigator: David Huang, MD, PhD         
Sub-Investigator: Winston Chamberlain, MD, PhD         
Sub-Investigator: John Clements, MD         
Sub-Investigator: Afshan Nanji, MD         
Sub-Investigator: Lorinna Lombardi, MD         
Sub-Investigator: Ellen Davis, MD         
Sub-Investigator: Seema Gupta, MD         
Sub-Investigator: Yan Li, PhD         
Sub-Investigator: Xinbo Zhang, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Yan Li, PhD Oregon Health and Science University

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Responsible Party: David Huang, Yan Li, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03504800     History of Changes
Other Study ID Numbers: IRB#000018036
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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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

Keywords provided by David Huang, Oregon Health and Science University:
OCT
Keratoconus

Additional relevant MeSH terms:
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Keratoconus
Corneal Opacity
Corneal Diseases
Eye Diseases