PregnancyCorvisPregNCT04433689
Corneal Biomechanics During Pregnancy
An observational study of Pregnancy, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Non-Contact measurement of corneal properties
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2016to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy pregnant women with uncomplicated singleton pregnancy
Who may be able to join
- females
- pregnant
- age 18 to 38 yo
- uncomplicated singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Ophthalmology
Zurich, Canton of Zurich, 8091
Marc Toeteberg-Harms, MD, FEBO, +41 44 255 - 1111 ext. +41442558794, marc.toeteberg@usz.ch
Özsoy Belgin, MD, +41442558794 ext. +41442558794, belgin.oezsoy@usz.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Non-Contact measurement of corneal properties
- Keywords
- pregnancy, corneal biomechanical properties, intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Contact measurement of corneal propertiesDevice
Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases. Receives: Device: Non-Contact measurement of corneal properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Deformation Amplitude
Change in Deformation Amplitude (in millimeters) at 3 month post delivery compared to during third trimester will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3 month post delivery compared to during third trimester of the pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Toeteberg-Harms, MD, FEBO, Principal investigator, University Hospital Zurich, Dpt. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433689
- Sponsor's protocol ID
- CorvisPreg
- Acronym
- CorvisPreg
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Corneal Biomechanics During Pregnancy
- ClinicalTrials.gov ID
- NCT04433689
- Acronym / sponsor ID
- CorvisPreg / CorvisPreg
- Conditions
- Pregnancy
- Keywords
- pregnancy, corneal biomechanical properties, intraocular pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Device: Non-Contact measurement of corneal propertiesPregnant woman, age 18 to 38 yo, with uncomplicated singleton pregnancy and no ocular diseases. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy pregnant women with uncomplicated singleton pregnancy
Key inclusion criteria (4 listed)
- females
- pregnant
- age 18 to 38 yo
- uncomplicated singleton pregnancy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Contact measurement of corneal propertiesCorneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc. | Device | Pregnant women |
Primary outcome
Change in Deformation Amplitude
Time frame: 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 Applanation Length
Time frame: 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.
Change in Corneal Velocity
Time frame: 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 corneal thickness
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Toeteberg-Harms, MD, FEBO principal investigator
University Hospital Zurich, Dpt. of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc o Toeteberg-Harms, MD, FEBO (+41442551111 ext. +41442551111, marc.toeteberg@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Deformation Amplitude (time frame: at 3 month post delivery compared to during third trimester). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.