The Influence of Hormonal Changes During Pregnancy on Corneal Biomechanics in Humans

Pregnancy Clinical Trial

Official title:

Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629264
• Other study ID #: CER-11-180
• Secondary ID: GE-OPHT-2012-1
• Status: Completed
• Phase: N/A
• First received: June 24, 2012
• Last updated: March 14, 2016
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 years

• Pregnancy confirmed by echography

• Before gestation week 14

Exclusion Criteria:

• Pre-existing corneal disease

• Previous eye surgery

• Inability to understand the nature of the study

• Patient with legal guardian

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

Gatzioufas Z, Thanos S. Acute keratoconus induced by hypothyroxinemia during pregnancy. J Endocrinol Invest. 2008 Mar;31(3):262-6. — View Citation

Giuffrè 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Jun 25. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No