Astigmatic Vector Analysis of Posterior Cornea - a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02698709
Collaborator
(none)
698
1
4
172.7

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine new diagnostic criteria for an eye disease called keratoconus.

Condition or Disease Intervention/Treatment Phase
  • Other: Analysis of anterior and posterior corneal surfaces

Detailed Description

Eyes of patients who distinctly present signs of keratoconus, for both eyes, at corneal tomography (an exam commonly used in such cases), and those who present such signs in only one eye were compared to eyes of unaffected patients. Several characteristics of anterior and posterior corneal astigmatism (special emphasis was given to the latter) were collectively assessed among all patients by a method referred to as vectorial analysis. Statistical tests were then performed, in an attempt to highlight differences among those three groups of patients and, eventually, define new diagnostic criteria.

Study Design

Study Type:
Observational
Actual Enrollment :
698 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Astigmatic Vector Analysis of Posterior Corneal Surface - a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Healthy corneas (C)

Corneas of normal candidates to refractive surgery who did not develop any sign of corneal ectasia after laser in situ keratomileusis during a two year follow-up period were analyzed by an Scheimpflug-based tomographer. Vector astigmatism analysis of anterior and posterior corneal surfaces were studied in accordance to method proposed by Thibos.

Other: Analysis of anterior and posterior corneal surfaces
Corneal data obtained from a Scheimpflug-based topographer were converted to astigmatic vectors in accordance to the method proposed by Thibos
Other Names:
  • Thibos' vectorial astigmatism analysis
  • Overt keratoconus (Kc)

    Whether both eyes manifested classic Kc-suggestive topographic features, such as corneal steepness higher than 47.20 diopters (D), superior-inferior asymmetry higher than 1.40 D and thinnest pachymetric reading lower than 500 micrometers. Such eyes were analyzed by an Scheimpflug-based tomographer. Vector astigmatism analysis of anterior and posterior corneal surfaces were studied in accordance to method proposed by Thibos.

    Other: Analysis of anterior and posterior corneal surfaces
    Corneal data obtained from a Scheimpflug-based topographer were converted to astigmatic vectors in accordance to the method proposed by Thibos
    Other Names:
  • Thibos' vectorial astigmatism analysis
  • Forme fruste keratoconus (FFKc)

    Whether only one eye manifested classic Kc-suggestive topographic features, such as corneal steepness higher than 47.20 diopters (D), superior-inferior asymmetry higher than 1.40 D and thinnest pachymetric reading lower than 500 micrometers, and the fellow eye seemed unaffected. Such unaffected eyes were analyzed by an Scheimpflug-based tomographer. Vector astigmatism analysis of anterior and posterior corneal surfaces were studied in accordance to method proposed by Thibos.

    Other: Analysis of anterior and posterior corneal surfaces
    Corneal data obtained from a Scheimpflug-based topographer were converted to astigmatic vectors in accordance to the method proposed by Thibos
    Other Names:
  • Thibos' vectorial astigmatism analysis
  • Outcome Measures

    Primary Outcome Measures

    1. Astigmatism corneal vectors (based on keratometric readings at the three millimeter optical zones for both corneal surfaces). [Through study completion, an average of 6 months.]

      Corneal tomography at an Scheimpflug-based tomographer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Good-quality Scheimpflug scans (approved by the device in the ''Examination Quality Specification'').
    Exclusion Criteria:
    • Previous eye surgery or trauma, and any sort of corneal scarring that might interfere with keratometric data acquisition.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clínica Oftalmológica do Hospital de Clínicas - FMUSP São Paulo Brazil 05.403-001

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Study Director: Milton R Alves, MD, PhD, Clínica Oftalmológica HCFM/USP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Giuliano de Oliveira Freitas, MD., MD, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02698709
    Other Study ID Numbers:
    • Clínica Oftalmológica HCFM/USP
    First Posted:
    Mar 4, 2016
    Last Update Posted:
    Mar 4, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Giuliano de Oliveira Freitas, MD., MD, University of Sao Paulo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 4, 2016