Clinical trial NCT03511495: Reliability of Topography Measurements in Keratoconus
Official title: Repeatability and Reliability of Galilei Corneal Topographer Measurements in Keratoconus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective study of patients seen at the Penn State Eye Center who have been diagnosed with keratoconus and are undergoing Galilei corneal topography. Patients will be selected to participate in the study based on inclusion/exclusion criteria. Each patient in the study will undergo five consecutive corneal topography measurements per keratoconic eye.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maximum (steepest) and minimum (flattest) keratometry values in the central zone
timeFrame: Measured at day 0 of study enrollment
Secondary outcomes:
measure: Thinnest pachymetry
timeFrame: Measured at day 0 of study enrollment
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Eye Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Seth Pantanelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.
citation: Demir S, Sonmez B, Yeter V, Ortak H. Comparison of normal and keratoconic corneas by Galilei Dual-Scheimpflug Analyzer. Cont Lens Anterior Eye. 2013 Oct;36(5):219-25. doi: 10.1016/j.clae.2013.04.001. Epub 2013 Apr 30.
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citation: Jahadi Hosseini HR, Katbab A, Khalili MR, Abtahi MB. Comparison of corneal thickness measurements using Galilei, HR Pentacam, and ultrasound. Cornea. 2010 Oct;29(10):1091-5. doi: 10.1097/ICO.0b013e3181cf98e5.
citation: Anayol MA, Guler E, Yagci R, Sekeroglu MA, Ylmazoglu M, Trhs H, Kulak AE, Ylmazbas P. Comparison of central corneal thickness, thinnest corneal thickness, anterior chamber depth, and simulated keratometry using galilei, Pentacam, and Sirius devices. Cornea. 2014 Jun;33(6):582-6. doi: 10.1097/ICO.0000000000000119.
citation: Park SH, Choi SK, Lee D, Jun EJ, Kim JH. Corneal thickness measurement using Orbscan, Pentacam, Galilei, and ultrasound in normal and post-femtosecond laser in situ keratomileusis eyes. Cornea. 2012 Sep;31(9):978-82. doi: 10.1097/ICO.0b013e31823d03fc.
citation: Crawford AZ, Patel DV, McGhee CN. Comparison and repeatability of keratometric and corneal power measurements obtained by Orbscan II, Pentacam, and Galilei corneal tomography systems. Am J Ophthalmol. 2013 Jul;156(1):53-60. doi: 10.1016/j.ajo.2013.01.029. Epub 2013 Mar 28.