Corneal Biomechanics During Pregnancy

NCT ID: NCT04433689

Last Updated: 2020-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

Pregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases.

Non-Contact measurement of corneal properties

Intervention Type DEVICE

Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.

Interventions

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Non-Contact measurement of corneal properties

Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Toeteberg-Harms, MD, FEBO

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Dpt. of Ophthalmology

Locations

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Department of Ophthalmology

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Marc o Toeteberg-Harms, MD, FEBO

Role: CONTACT

+41442551111 ext. +41442551111

Belgin o Özsoy, MD

Role: CONTACT

+41442551111 ext. +41442551111

Facility Contacts

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Marc Toeteberg-Harms, MD, FEBO

Role: primary

+41 44 255 - 1111 ext. +41442558794

Özsoy Belgin, MD

Role: backup

+41442558794 ext. +41442558794

Other Identifiers

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CorvisPreg

Identifier Type: -

Identifier Source: org_study_id

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