Corneal Biomechanics During Pregnancy

• Conditions: Pregnancy
• Interventions: Device: Non-Contact measurement of corneal properties

• Registration Number: NCT04433689
• Lead Sponsor: University of Zurich

Brief Summary

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Detailed Description

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Measurement of intraocular pressure is highly dependant on corneal properties. With the Corvis ST device by Ocular Inc. it is possible to measure intraocular pressure and investigated corneal biomechanics. The aim of this study is therefore to compare corneal biomechanical properties during the third trimester with corneal biomechanical properties at 3 months after delivery.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• females
• pregnant
• age 18 to 38 yo
• uncomplicated singleton pregnancy

Exclusion Criteria

• any history of ocular disease or surgery other than conjunctivitis, especially no history of glaucoma or corneal disease
• systemic diseases, i.e. diabetes, hypertension, collagenase
• current contact lens wear
• before pregnancy taking any systemic or ocular medications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	Non-Contact measurement of corneal properties	Pregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases.

Primary Outcome Measures

Name	Time	Method
Change in corneal thickness	at 3 month post delivery compared to during third trimester of the pregnancy	Change in corneal thickness (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
Change in Intraocular pressure	at 3 month post delivery compared to during third trimester of the pregnancy	Change in intraocular pressure (in millimeters of mercury, mmHg) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
Change in Deformation Amplitude	at 3 month post delivery compared to during third trimester	Change in Deformation Amplitude (in millimeters) at 3 month post delivery compared to during third trimester will be assessed.
Change in Corneal Velocity	at 3 month post delivery compared to during third trimester of the pregnancy	Change in Corneal Velocity (in meters/second) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.
Change in Applanation Length	at 3 month post delivery compared to during third trimester of the pregnancy	Change in Applanation Length (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

Trial Locations

Locations (1)

Department of Ophthalmology; 🇨🇭 Zurich, ZH, Switzerland