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

NCT02698709 | Completed DMC

• 1 other identifier: Clínica Oftalmológica HCFM/USP
• Study Type: observational
• Target: 698
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keratoconus

Keywords

Keratoconus; Corneal Topography; Diagnosis; Keratomileusis, Laser In Situ

Outcome Measures

Primary Outcomes (1)

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

  Corneal tomography at an Scheimpflug-based tomographer

  Through study completion, an average of 6 months.

Study Arms (3)

Healthy corneas (C)

Corneas of normal candidates to refractive surgery who did not develop any sign of corneal ectasia after laser in situ keratomileusis during a two year follow-up period were analyzed by an Scheimpflug-based tomographer. Vector astigmatism analysis of anterior and posterior corneal surfaces were studied in accordance to method proposed by Thibos.

Other: Analysis of anterior and posterior corneal surfaces

Overt keratoconus (Kc)

Whether both eyes manifested classic Kc-suggestive topographic features, such as corneal steepness higher than 47.20 diopters (D), superior-inferior asymmetry higher than 1.40 D and thinnest pachymetric reading lower than 500 micrometers. Such eyes were analyzed by an Scheimpflug-based tomographer. Vector astigmatism analysis of anterior and posterior corneal surfaces were studied in accordance to method proposed by Thibos.

Other: Analysis of anterior and posterior corneal surfaces

Forme fruste keratoconus (FFKc)

Whether only one eye manifested classic Kc-suggestive topographic features, such as corneal steepness higher than 47.20 diopters (D), superior-inferior asymmetry higher than 1.40 D and thinnest pachymetric reading lower than 500 micrometers, and the fellow eye seemed unaffected. Such unaffected eyes were analyzed by an Scheimpflug-based tomographer. Vector astigmatism analysis of anterior and posterior corneal surfaces were studied in accordance to method proposed by Thibos.

Other: Analysis of anterior and posterior corneal surfaces

Interventions

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

Also known as: Thibos' vectorial astigmatism analysis

Forme fruste keratoconus (FFKc); Healthy corneas (C); Overt keratoconus (Kc)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Two databases of patients were examined at the Instituto de Olhos Renato Ambrósio (Rio de Janeiro, Brazil), between July 2004 and October 2013. One of the databases contained information of normal candidates to refractive surgery who did not develop any sign of corneal ectasia after laser in situ keratomileusis during a two year follow-up period (C). The second database included information concerning corneas with keratoconus (Kc), categorized as overt Kc, if both eyes manifested classic Kc-suggestive topographic features, such as corneal steepness higher than 47.20 diopters (D), superior-inferior asymmetry higher than 1.40 D and thinnest pachymetric reading lower than 500 micrometers; or forme fruste (FFKc), if only one eye exhibited such features.

You may qualify if:

• Good-quality Scheimpflug scans (approved by the device in the ''Examination Quality Specification'').

You may not qualify if:

• Previous eye surgery or trauma, and any sort of corneal scarring that might interfere with keratometric data acquisition.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clínica Oftalmológica do Hospital de Clínicas - FMUSP

São Paulo, São Paulo, 05.403-001, Brazil

Location

Related Publications (30)

• Li X, Yang H, Rabinowitz YS. Keratoconus: classification scheme based on videokeratography and clinical signs. J Cataract Refract Surg. 2009 Sep;35(9):1597-603. doi: 10.1016/j.jcrs.2009.03.050.

  PMID: 19683159 RESULT

• Goebels S, Eppig T, Wagenpfeil S, Cayless A, Seitz B, Langenbucher A. Staging of keratoconus indices regarding tomography, topography, and biomechanical measurements. Am J Ophthalmol. 2015 Apr;159(4):733-8. doi: 10.1016/j.ajo.2015.01.014. Epub 2015 Jan 26.

  PMID: 25634534 RESULT

• Moreira LB, Bardal RA, Crisigiovanni LR. Contact lenses fitting after intracorneal ring segments implantation in keratoconus. Arq Bras Oftalmol. 2013 Jul-Aug;76(4):215-7. doi: 10.1590/s0004-27492013000400004.

  PMID: 24061830 RESULT

• Raiskup F, Theuring A, Pillunat LE, Spoerl E. Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: ten-year results. J Cataract Refract Surg. 2015 Jan;41(1):41-6. doi: 10.1016/j.jcrs.2014.09.033.

  PMID: 25532633 RESULT

• Gomes JA, Tan D, Rapuano CJ, Belin MW, Ambrosio R Jr, Guell JL, Malecaze F, Nishida K, Sangwan VS; Group of Panelists for the Global Delphi Panel of Keratoconus and Ectatic Diseases. Global consensus on keratoconus and ectatic diseases. Cornea. 2015 Apr;34(4):359-69. doi: 10.1097/ICO.0000000000000408.

  PMID: 25738235 RESULT

• Muftuoglu O, Ayar O, Ozulken K, Ozyol E, Akinci A. Posterior corneal elevation and back difference corneal elevation in diagnosing forme fruste keratoconus in the fellow eyes of unilateral keratoconus patients. J Cataract Refract Surg. 2013 Sep;39(9):1348-57. doi: 10.1016/j.jcrs.2013.03.023. Epub 2013 Jun 29.

  PMID: 23820305 RESULT

• Smadja D, Santhiago MR, Mello GR, Krueger RR, Colin J, Touboul D. Influence of the reference surface shape for discriminating between normal corneas, subclinical keratoconus, and keratoconus. J Refract Surg. 2013 Apr;29(4):274-81. doi: 10.3928/1081597X-20130318-07.

  PMID: 23557226 RESULT

• Torricelli AA, Bechara SJ, Wilson SE. Screening of refractive surgery candidates for LASIK and PRK. Cornea. 2014 Oct;33(10):1051-5. doi: 10.1097/ICO.0000000000000171.

  PMID: 25014146 RESULT

• Randleman JB, Akhtar J, Lynn MJ, Ambrosio R Jr, Dupps WJ Jr, Krueger RR, Klyce SD. Comparison of objective and subjective refractive surgery screening parameters between regular and high-resolution Scheimpflug imaging devices. J Cataract Refract Surg. 2015 Feb;41(2):286-94. doi: 10.1016/j.jcrs.2014.06.026. Epub 2014 Dec 20.

  PMID: 25537685 RESULT

• Ramos IC, Correa R, Guerra FP, Trattler W, Belin MW, Klyce SD, Fontes BM, Schor P, Smolek MK, Dawson DG, Chalita MR, Cazal JO, Ruiz M, Randleman JB, Ambrosio R Jr. Variability of subjective classifications of corneal topography maps from LASIK candidates. J Refract Surg. 2013 Nov;29(11):770-5. doi: 10.3928/1081597X-20130823-01. Epub 2013 Aug 30.

  PMID: 23980708 RESULT

• Qin B, Chen S, Brass R, Li Y, Tang M, Zhang X, Wang X, Wang Q, Huang D. Keratoconus diagnosis with optical coherence tomography-based pachymetric scoring system. J Cataract Refract Surg. 2013 Dec;39(12):1864-71. doi: 10.1016/j.jcrs.2013.05.048.

  PMID: 24427794 RESULT

• Ruisenor Vazquez PR, Galletti JD, Minguez N, Delrivo M, Fuentes Bonthoux F, Pfortner T, Galletti JG. Pentacam Scheimpflug tomography findings in topographically normal patients and subclinical keratoconus cases. Am J Ophthalmol. 2014 Jul;158(1):32-40.e2. doi: 10.1016/j.ajo.2014.03.018. Epub 2014 Apr 5.

  PMID: 24709808 RESULT

• Buhren J, Schaffeler T, Kohnen T. Validation of metrics for the detection of subclinical keratoconus in a new patient collective. J Cataract Refract Surg. 2014 Feb;40(2):259-68. doi: 10.1016/j.jcrs.2013.07.044. Epub 2013 Dec 18.

  PMID: 24360499 RESULT

• Galletti JD, Ruisenor Vazquez PR, Minguez N, Delrivo M, Bonthoux FF, Pfortner T, Galletti JG. Corneal asymmetry analysis by pentacam scheimpflug tomography for keratoconus diagnosis. J Refract Surg. 2015 Feb;31(2):116-23. doi: 10.3928/1081597X-20150122-07.

  PMID: 25735045 RESULT

• Ambrosio R Jr, Valbon BF, Faria-Correia F, Ramos I, Luz A. Scheimpflug imaging for laser refractive surgery. Curr Opin Ophthalmol. 2013 Jul;24(4):310-20. doi: 10.1097/ICU.0b013e3283622a94.

  PMID: 23680761 RESULT

• Montalban R, Pinero DP, Javaloy J, Alio JL. Scheimpflug photography-based clinical characterization of the correlation of the corneal shape between the anterior and posterior corneal surfaces in the normal human eye. J Cataract Refract Surg. 2012 Nov;38(11):1925-33. doi: 10.1016/j.jcrs.2012.06.050. Epub 2012 Sep 14.

  PMID: 22981614 RESULT

• Montalban R, Pinero DP, Javaloy J, Alio JL. Correlation of the corneal toricity between anterior and posterior corneal surfaces in the normal human eye. Cornea. 2013 Jun;32(6):791-8. doi: 10.1097/ICO.0b013e31827bf898.

  PMID: 23328698 RESULT

• Koch DD, Ali SF, Weikert MP, Shirayama M, Jenkins R, Wang L. Contribution of posterior corneal astigmatism to total corneal astigmatism. J Cataract Refract Surg. 2012 Dec;38(12):2080-7. doi: 10.1016/j.jcrs.2012.08.036. Epub 2012 Oct 12.

  PMID: 23069271 RESULT

• Pinero DP, Alio JL, Tomas J, Maldonado MJ, Teus MA, Barraquer RI. Vector analysis of evolutive corneal astigmatic changes in keratoconus. Invest Ophthalmol Vis Sci. 2011 Jun 8;52(7):4054-62. doi: 10.1167/iovs.10-6856.

  PMID: 21372010 RESULT

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  PMID: 20554609 RESULT

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  PMID: 11165859 RESULT

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  PMID: 19182699 RESULT

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  PMID: 19891286 RESULT

MeSH Terms

Conditions

Keratoconus; Disease

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Milton R Alves, MD, PhD

  Clínica Oftalmológica HCFM/USP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 4, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)