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Recruiting NCT03504800

OCT in Diagnosis of Irregular Corneas

— Observational Keratoconus Corneal Opacity Corneal Dystrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical Coherence Tomography.
Who it may be relevant to
Registry conditions: Keratoconus, Corneal Opacity, Corneal Dystrophy. Basic parameters: 14 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

  • Develop OCT-based system to classify and evaluate corneal-shape irregularities [Time frame: 1 day]
  • Develop OCT-based system to classify and evaluate corneal-shape irregularities [Time frame: 1 day]
  • Develop OCT metrics for more sensitive detection of keratoconus progression [Time frame: 4 year]
  • Develop OCT metrics for more sensitive detection of keratoconus progression [Time frame: 4 year]
  • Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas [Time frame: 1 year]
  • Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Humberto Martinez — Portland

Identifiers

NCT: NCT03504800 · IRB#000018036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗