Corneal Biomechanics During Pregnancy

NCT04433689 | Unknown

• 1 other identifier: CorvisPreg
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

pregnancy; corneal biomechanical properties; intraocular pressure

Outcome Measures

Primary Outcomes (5)

• Change in Deformation Amplitude

  Change in Deformation Amplitude (in millimeters) at 3 month post delivery compared to during third trimester will be assessed.

  at 3 month post delivery compared to during third trimester

• Change in Applanation Length

  Change in Applanation Length (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

  at 3 month post delivery compared to during third trimester of the pregnancy

• Change in Corneal Velocity

  Change in Corneal Velocity (in meters/second) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

  at 3 month post delivery compared to during third trimester of the pregnancy

• Change in corneal thickness

  Change in corneal thickness (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

  at 3 month post delivery compared to during third trimester of the pregnancy

• Change in Intraocular pressure

  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.

  at 3 month post delivery compared to during third trimester of the pregnancy

Study Arms (1)

Pregnant women

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

Device: Non-Contact measurement of corneal properties

Interventions

Non-Contact measurement of corneal properties DEVICE

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

Pregnant women

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy pregnant women with uncomplicated singleton pregnancy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Study Officials

• Marc Toeteberg-Harms, MD, FEBO

  University Hospital Zurich, Dpt. of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc o Toeteberg-Harms, MD, FEBO

CONTACT

+41442551111; marc.toeteberg@usz.ch

Belgin o Özsoy, MD

CONTACT

+41442551111; belgin.oezsoy@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: January 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)