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Completed

NCT Number: NCT02698709

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

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

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Key information

Conditions

Keratoconus Corneal Diseases Disease Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Oftalmológica do Hospital de Clínicas - FMUSP

São Paulo, 05.403-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analysis of anterior and posterior corneal surfaces

Other

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

Primary outcomes

  1. Astigmatism corneal vectors (based on keratometric readings at the three millimeter optical zones for both corneal surfaces).

    Time frame: Through study completion, an average of 6 months.

    Corneal tomography at an Scheimpflug-based tomographer

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2016
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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