Corneal Biomechanics During Pregnancy

Pregnancy Clinical Trial

— CorvisPreg  

Official title:

Change in Corneal Biomechanics During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433689
• Other study ID #: CorvisPreg
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: January 31, 2021

Study information

• Verified date: June 2020
• Source: University of Zurich
• Contact: Marc o Toeteberg-Harms, MD, FEBO
• Phone: +41442551111
• Email: marc.toeteberg[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Non-Contact measurement of corneal properties
Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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