The Influence of Hormonal Changes During Pregnancy on Corneal Biomechanics in Humans
NCT ID: NCT01629264
Last Updated: 2016-03-16
Study Results
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Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2012-06-30
2014-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Ocular Response Analyzer
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.
Scheimpflug measurement
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.
Blood sample
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnancy confirmed by echography
* Before gestation week 14
Exclusion Criteria
* Previous eye surgery
* Inability to understand the nature of the study
* Patient with legal guardian
18 Years
FEMALE
Yes
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Farhad Hafezi
Professor and Chairman of Ophthalmology
Principal Investigators
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Farhad Hafezi, MDPhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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University Hospital Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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References
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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.
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.
Other Identifiers
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GE-OPHT-2012-1
Identifier Type: OTHER
Identifier Source: secondary_id
CER-11-180
Identifier Type: -
Identifier Source: org_study_id
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