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Clinical Trials/NCT03511495
NCT03511495CompletedNot Applicable

Repeatability and Reliability of Galilei Corneal Topographer Measurements in Keratoconus

Milton S. Hershey Medical Center1 site in 1 country86 target enrollmentStarted: September 11, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
Maximum (steepest) and minimum (flattest) keratometry values in the central zone

Study Overview

Brief Summary

The purpose of this study is to assess the reliability and repeatability of the parameters obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in eyes with keratoconus.

Detailed Description

Keratoconus is a progressive corneal degeneration characterized by progressive steepening and thinning of the central or paracentral cornea leading to corneal protrusion and resulting irregular astigmatism and high myopia. This disorder is usually bilateral and is linked to atopy and excessive eye rubbing, although the precise pathophysiology behind development of this condition is unclear. Keratoconus is the most common corneal degeneration in the United States, affecting between 50 and 230 subjects per 100,000 population.

Early diagnosis and appropriate management of keratoconus relies greatly on accurate assessment of corneal topographic measurements. It is therefore imperative that the data obtained via corneal topography devices is accurate and reliable.

The GALILEI Dual Scheimpflug Analyzer integrates Placido disc topography and dual Scheimpflug tomography to assess anterior and posterior corneal curvature data. Although there have been several studies performed assessing the ability of the Galilei to accurately distinguish keratoconus from unaffected eyes and investigating interdevice reliability between the Galilei analyzer and other tomographers, to our knowledge the repeatability of measurements obtained in this population via the Galilei device has been incompletely evaluated to date.

Corneal topography data obtained via the Galilei device is relied upon heavily in clinical decision making for keratoconic patients both in the Hershey Eye Clinic and in a great number of ophthalmology practices world-wide. It is vital that the accuracy and repeatability of these measurements obtained via the Galilei device are investigated.

The primary endpoint to be measured in the study will be the maximum (steepest) and minimum (flattest) keratometry values in the central zone.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patientswho are older than 18 years of age
  • Patients who are scheduled to undergo Galilei dual-scheimpflug corneal topography testing
  • Patients who have been diagnosed with keratoconus
  • Measurements with a reported reliability of 'good' from the topographer

Exclusion Criteria

  • Patients who have undergone any prior surgical intervention involving the cornea (i.e. cornea transplant or INTACS, or corneal cross linking)

Outcomes

Primary Outcomes

Maximum (steepest) and minimum (flattest) keratometry values in the central zone

Time Frame: Measured at day 0 of study enrollment

Assessment of the steepness of the cornea

Secondary Outcomes

  • Thinnest pachymetry(Measured at day 0 of study enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seth M Pantanelli

Assistant Professor of Ophthalmology

Milton S. Hershey Medical Center

Study Sites (1)

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