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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01629264
Enrollment
50
Registered
2012-06-27
Start date
2012-06-30
Completion date
2014-06-30
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Cornea, biomechanics, pregnancy, keratoconus, refractive surgery

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.

Interventions

DEVICEOcular 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.

DEVICEScheimpflug 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.

OTHERBlood 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.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlate oestradiol and TSH plasma changes with changes in corneal CRF and CH and topographical changes15 months3 examinations during pregnancy (gestation week 10-14, 20-26, and 36-40) and one visit at 6 months after pregnancy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026