The Characteristics of Backscattering With Depth in the Progression of Keratoconus

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06050629
Collaborator
(none)
223
1
35.9
6.2

Study Details

Study Description

Brief Summary

To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. A Scheimpflug corneal tomography image and caliper tool were used to obtain backscatter at every 2% depth at the thinnest point of the cornea, with the measured values expressed in grayscale units (GSU).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    223 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Characteristics of Backscattering With Depth in the Progression of Keratoconus and Its Role in Forme Fruste Keratoconus Detection
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Dec 1, 2022
    Actual Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    forme fruste keratoconus

    1) no other eye abnormalities except myopia and astigmatism; 2) transparent cornea; 3) no positive signs of keratoconus on slit lamp examination or morphology examination (excluding the appearance of keratoconus as described above, and simultaneously satisfying A0B0C0D0, Index of Surface variance (ISV) < 30, and Keratoconus Index (KI) < 1.07); and 4) Belin/Ambrósio enhanced ectasia total derivation value(BAD-D)≤1.6

    Clinical keratoconus

    46.5 D ≤ Mean K <52 D; 55≤ ISV<200; and 1.10 ≤ KI <1.50

    severe keratoconus

    Mean K ≥ 52D; ISV≥ 200; and KI≥ 1.50

    normal eye

    one eye of healthy participants before refractive surgery were randomly selected. Comprehensive ophthalmic examinations were performed before surgery, which confirmed that the cornea was clear and normal in shape. For this group, there was no family history of keratoconus, no other diseases except ametropia, and no corneal dilatation one year after surgery.

    Outcome Measures

    Primary Outcome Measures

    1. backscattering [through study completion, an average of 1 year]

      Standard measurements were performed using a Pentacam (Pentacam HR; Oculus, Wetzlar, Germany);The average brightness of a predetermined area of the cornea was calculated, shown as densitometry, and recorded in GSU ranging from 0 to 100 (0, cornea is transparent without opacity; 100, cornea is completely opaque).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. BCVA <20/20 and a history of myopia or astigmatism;

    2. presence of any of the following positive signs on slit lamp examination: corneal stromal thinning, cone-shaped anterior protrusions, Fleischer's ring, Vogt's striae, epithelial or subepithelial scarring;

    3. abnormal corneal topography (maximum keratometry (K) value of >47.2 diopters (D), bow-tie pattern with skewed radial axes, or inferior-superior asymmetry(3-mm I-S keratometric difference >1.4 D).

    Exclusion Criteria:
    1. Patients with severe corneal scarring that affected light scattering and density maps showing "black holes" 2.Participatients with other corneal diseases 3. Eyes that have undergone surgery or trauma 4. Eyes with corneal dystrophy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Eye Hospital Tianjin Tianjin China

    Sponsors and Collaborators

    • Tianjin Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT06050629
    Other Study ID Numbers:
    • KY-2023020
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2023