Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-06 @ 4:57 PM
Study NCT ID:
NCT03511495
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2018-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Topography Measurements in Keratoconus
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
Repeatability and Reliability of Galilei Corneal Topographer Measurements in Keratoconus
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Secondary endpoints will be maximum keratometry across the entire area scanned, axis of corneal astigmatism, anterior and posterior best fit spheres in float mode with the diameter set to 8 mm, maximum anterior and posterior elevations, thinnest corneal thickness, and corneal asphericity at 6 mm, root mean square (RMS) of the HOAs, RMS of the third-order coma, coma axis, vertical and horizontal coma and spherical aberration.
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.
Secondary endpoints will be maximum keratometry across the entire area scanned, axis of corneal astigmatism, anterior and posterior best fit spheres in float mode with the diameter set to 8 mm, maximum anterior and posterior elevations, thinnest corneal thickness, and corneal asphericity at 6 mm, root mean square (RMS) of the HOAs, RMS of the third-order coma, coma axis, vertical and horizontal coma and spherical aberration.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: