Reliability of Topography Measurements in Keratoconus

NCT03511495 | Completed FDA Device

• 1 other identifier: STUDY00007951
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

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

  Assessment of the steepness of the cornea

  Measured at day 0 of study enrollment

Secondary Outcomes (1)

• Thinnest pachymetry

  Measured at day 0 of study enrollment

Study Arms (1)

Keratoconic Patients

Diagnostic Test: Galilei Corneal Topographer

Interventions

Galilei Corneal Topographer DIAGNOSTIC_TEST

A series of five measurements via the Galilei corneal topographer of each keratoconic eye in quick succession

Keratoconic Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Eye Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (11)

• Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.

  PMID: 9493273 BACKGROUND

• 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.

  PMID: 10906086 BACKGROUND

• 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.

  PMID: 23642799 BACKGROUND

• Holladay JT. Keratoconus detection using corneal topography. J Refract Surg. 2009 Oct;25(10 Suppl):S958-62. doi: 10.3928/1081597X-20090915-11.

  PMID: 19848378 BACKGROUND

• Guler E, Yagci R, Akyol M, Arslanyilmaz Z, Balci M, Hepsen IF. Repeatability and reproducibility of Galilei measurements in normal keratoconic and postrefractive corneas. Cont Lens Anterior Eye. 2014 Oct;37(5):331-6. doi: 10.1016/j.clae.2014.04.004. Epub 2014 Jun 14.

  PMID: 24938125 BACKGROUND

• Meyer JJ, Gokul A, Vellara HR, Prime Z, McGhee CN. Repeatability and Agreement of Orbscan II, Pentacam HR, and Galilei Tomography Systems in Corneas With Keratoconus. Am J Ophthalmol. 2017 Mar;175:122-128. doi: 10.1016/j.ajo.2016.12.003. Epub 2016 Dec 18.

  PMID: 27993593 BACKGROUND

• Feizi S, Yaseri M, Kheiri B. Predictive Ability of Galilei to Distinguish Subclinical Keratoconus and Keratoconus from Normal Corneas. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):8-16. doi: 10.4103/2008-322X.180707.

  PMID: 27195079 BACKGROUND

• 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.

  PMID: 20628301 BACKGROUND

• 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.

  PMID: 24763122 BACKGROUND

• 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.

  PMID: 22699561 BACKGROUND

• 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.

  PMID: 23540708 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Seth Pantanelli, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 27, 2018
• Study Start: September 11, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

US (1)