The Influence of Hormonal Changes During Pregnancy on Corneal Biomechanics in Humans
|ClinicalTrials.gov Identifier: NCT01629264|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : March 16, 2016
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 or disease||Intervention/treatment|
|Pregnancy||Device: Ocular Response Analyzer Device: Scheimpflug measurement Other: Blood sample|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- 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.
- Correlate oestradiol and TSH plasma changes with changes in corneal CRF and CH and topographical changes [ Time Frame: 15 months ]3 examinations during pregnancy (gestation week 10-14, 20-26, and 36-40) and one visit at 6 months after pregnancy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629264
|University Hospital Geneva|
|Geneva, GE, Switzerland, 1211|
|Principal Investigator:||Farhad Hafezi, MDPhD||University Hospital, Geneva|