Corneal Biomechanics During Pregnancy (CorvisPreg)

Change in Corneal Biomechanics During Pregnancy

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Device: Non-Contact measurement of corneal properties

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Recruiting
      • Department of Ophthalmology
      • Contact: Marc Toeteberg-Harms, MD, FEBO; Phone Number: +41442558794 +41 44 255 - 1111; Email: marc.toeteberg@usz.ch
      • Principal Investigator: Marc Toeteberg-Harms, MD
      • Contact: Özsoy Belgin, MD; Phone Number: +41442558794 +41442558794; Email: belgin.oezsoy@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

healthy pregnant women with uncomplicated singleton pregnancy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women; Pregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases.	Device: Non-Contact measurement of corneal properties; Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Marc Toeteberg-Harms, MD, FEBO, University Hospital Zurich, Dpt. of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: pregnancy; intraocular pressure; corneal biomechanical properties
• Other Study ID Numbers: CorvisPreg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No