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

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.

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Key information

Conditions

Pregnancy Corneal Diseases Eye Diseases Keratoconus

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 27, 2012
Registry last updated: Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed