NCT01629264|CompletedDMC
The Influence of Hormonal Changes During Pregnancy on Corneal Biomechanics in Humans
Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans
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Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans
Sponsor study identifier
Secondary identifiers
OTHER · University of Geneva, Switzerland
observational
50
1 country
1
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)The intraocular pressure in the human bulbus requires that the "wall" of the eye shows a certain (bio)mechanical strength. The human cornea represents the anterior portion of this wall. Since several years, there is a growing interest in the ophthalmological community for identifying factors modulating the biomechanical stability of the human cornea. Reasons are twofold: advances in keratoconus research and the increasing numbers of refractive laser surgery procedures with (correspondingly) increasing numbers of complications due to non-respecting the limits of corneal biomechanics. There is evidence that oestrogen, but also thyroïd hormone changes have a major impact on corneal biomechanics. A number of recent observational studies have reported on keratoconus and refractive laser surgery patients with decompensating biomechanics during pregnancy. Both hormones also show physiological changes during pregnancy and little is known about the impact of these physiological changes on the human cornea. The aim of this study is to establish baseline values for physiological changes in the human cornea during pregnancy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 24, 2012
Actual (reported)June 27, 2012
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)Correlate oestradiol and TSH plasma changes with changes in corneal CRF and CH and topographical changes
3 examinations during pregnancy (gestation week 10-14, 20-26, and 36-40) and one visit at 6 months after pregnancy
15 months
To measure corneal biomechanics, specifically corneal hysteresis (CH) and the Corneal Resistance Factor (CRF). The devise measures in a non-contact manner, by analyzing the deformation of the cornea upon a defined pulse of air.
A Scheimpflug camera will be used in a non-contact manner to assess topographical data from the anterior and posterior corneal surface as well as detailed data on corneal thickness.
Pregnant women at the Dept. of Gynecology and Obstetrics of the University Hospital of Geneva
University Hospital Geneva
Geneva, Canton of Geneva, 1211, Switzerland
Gatzioufas Z, Thanos S. Acute keratoconus induced by hypothyroxinemia during pregnancy. J Endocrinol Invest. 2008 Mar;31(3):262-6. doi: 10.1007/BF03345600.
Giuffre G, Di Rosa L, Fiorino F, Bubella DM, Lodato G. Variations in central corneal thickness during the menstrual cycle in women. Cornea. 2007 Feb;26(2):144-6. doi: 10.1097/01.ico.0000244873.08127.3c.
Hafezi F, Iseli HP. Pregnancy-related exacerbation of iatrogenic keratectasia despite corneal collagen crosslinking. J Cataract Refract Surg. 2008 Jul;34(7):1219-21. doi: 10.1016/j.jcrs.2008.02.036.
Farhad Hafezi, MDPhD
University Hospital, Geneva
50 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2012
First Posted
June 27, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Correlation Between PIF Maternal Serum Levels and Pregnancy Outcome
A blood sample will be taken at 6 months after surgery to determine the levels of several hormones. The blood needed to détermine hormone levels during pregnancy will be acquired during the routine examinations that are performed during pregnancy. Here, blood is taken routinely and an additional volume is taken for the purpose of this study.
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Padmanabhan P, Radhakrishnan A, Natarajan R. Pregnancy-triggered iatrogenic (post-laser in situ keratomileusis) corneal ectasia--a case report. Cornea. 2010 May;29(5):569-72. doi: 10.1097/ICO.0b013e3181bd9f2d.
Spoerl E, Zubaty V, Raiskup-Wolf F, Pillunat LE. Oestrogen-induced changes in biomechanics in the cornea as a possible reason for keratectasia. Br J Ophthalmol. 2007 Nov;91(11):1547-50. doi: 10.1136/bjo.2007.124388. Epub 2007 Jun 25.
Suzuki T, Kinoshita Y, Tachibana M, Matsushima Y, Kobayashi Y, Adachi W, Sotozono C, Kinoshita S. Expression of sex steroid hormone receptors in human cornea. Curr Eye Res. 2001 Jan;22(1):28-33. doi: 10.1076/ceyr.22.1.28.6980.
Spoerl E, Zubaty V, Terai N, Pillunat LE, Raiskup F. Influence of high-dose cortisol on the biomechanics of incubated porcine corneal strips. J Refract Surg. 2009 Sep;25(9):S794-8. doi: 10.3928/1081597X-20090813-06.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
March 16, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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