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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Farhad Hafezi, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01629264
First received: June 24, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
 Device: Ocular Response Analyzer
Device: Scheimpflug measurement
Other: Blood sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Correlate oestradiol and TSH plasma changes with changes in corneal CRF and CH and topographical changes [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    3 examinations during pregnancy (gestation week 10-14, 20-26, and 36-40) and one visit at 6 months after pregnancy


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: ORA
    Device: 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 Name: Pentacam
    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.
    Other Name: Blood sample
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629264

Contacts
Contact: Farhad Hafezi, MDPhD +41223828360 farhad.hafezi@unige.ch
Contact: Vanessa Strueven, MD + 41223828400 vanessa.strueven@hcuge.ch

Locations
Switzerland
University Hospital Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Vanessa Strueven, MD     + 41223828400     vanessa.strueven@hcuge.ch    
Contact: David Tabibian, MD     + 41223828400     david.tabibian@hcuge.ch    
Principal Investigator: Farhad Hafezi, MDPhD            
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Farhad Hafezi, MDPhD University Hospital, Geneva
  More Information

Publications:

Responsible Party: Farhad Hafezi, Professor and Chairman of Ophthalmology, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01629264     History of Changes
Other Study ID Numbers: CER-11-180, GE-OPHT-2012-1
Study First Received: June 24, 2012
Last Updated: June 26, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Cornea
biomechanics
pregnancy
keratoconus
refractive surgery

ClinicalTrials.gov processed this record on May 19, 2013