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

NCT01629264 | Completed DMC

• 2 other identifiers: CER-11-180GE-OPHT-2012-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

Cornea; biomechanics; pregnancy; keratoconus; refractive surgery

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ocular Response Analyzer DEVICE

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.

Also known as: ORA

Scheimpflug measurement DEVICE

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.

Also known as: Pentacam

Blood sample OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at the Dept. of Gynecology and Obstetrics of the University Hospital of Geneva

You may qualify if:

• Older than 18 years
• Pregnancy confirmed by echography
• Before gestation week 14

You may not qualify if:

• Pre-existing corneal disease
• Previous eye surgery
• Inability to understand the nature of the study
• Patient with legal guardian

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (7)

• Gatzioufas Z, Thanos S. Acute keratoconus induced by hypothyroxinemia during pregnancy. J Endocrinol Invest. 2008 Mar;31(3):262-6. doi: 10.1007/BF03345600.

  PMID: 18401210 BACKGROUND

• 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.

  PMID: 17251801 BACKGROUND

• 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.

  PMID: 18571094 BACKGROUND

• 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.

  PMID: 20335804 BACKGROUND

• 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.

  PMID: 17591666 BACKGROUND

• 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.

  PMID: 11402376 BACKGROUND

• 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.

  PMID: 19772253 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases; Keratoconus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Farhad Hafezi, MDPhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Ophthalmology

Study Record Dates

• First Submitted: June 24, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

CH (1)