Corneal BiomechanicsNCT03500523
Corneal Biomechanical Properties in Pregnancy
A study testing corneal biomechanical properties in people with Corneal Biomechanics and Pregnancy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corneal Biomechanics, Pregnancy
- What is being tested?
- corneal biomechanical properties
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Mar 2018
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were included in the study.
Who cannot join
- Exclusion criteria included history of intraocular surgery or refractive surgery, history of glaucoma or glaucoma suspicion, contact lens wear, systemic autoimmune disease or diabetes and usage of eye drop and oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were enrolled in the study. All subjects had a detailed ophthalmologic examination including the best corrected visual acuity with a Snellen chart, slit- lamp biomicroscopic evaluation, and indirect fundoscopy. The biomechanical properties Corneal Hysteresis, Corneal resistance factor, corneal compensated intraocular pressure and Goldmann-correlated intraocular pressure values were measured with ORA (Ocular Response Analyzer, software version 1.02, Reichert, Inc.) Central corneal thickness was measured with a built-in ultrasonic pachymeter attached to the ORA device.Axial length , Anterior chamber depth , and keratometry readings were acquired with an ocular biometer (IOLMaster; Carl-Zeiss Meditec, Inc.) before CCT determinations had been taken. Results of these parameters were compared between pregnant group and healthy control group.
- Conditions
- Corneal Biomechanics, Pregnancy
- Being tested
- corneal biomechanical properties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal biomechanical propertiesDiagnostic test
We want to investigate changes of corneal biomechanical properties during pregnancy. The Ocular Response Analyzer (ORA) evaluate the in vivo corneal biomechanical properties in form of corneal hysteresis (CH) and corneal resistance factor (CRF)
| Study group | Role | What they receive |
|---|---|---|
| 1-study group | Experimental | study group: pregnant women Receives: Diagnostic Test: corneal biomechanical properties |
| 2-control group | Experimental | control group: healthy non pregnant women Receives: Diagnostic Test: corneal biomechanical properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of corneal hysteresis during pregnancy
we analyzed the biomechanical properties of the cornea in terms of corneal hysteresis (mmHg) by using ocular response analyzer device in healthy pregnant women and compared the data with non pregnant women.
Measured: three months
changes of corneal resistance factor during pregnancy
we analyzed the biomechanical properties of the cornea in terms of corneal resistance factor (mmHg) by using ocular response analyzer device in healthy pregnant women and compared the data with non pregnant women.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jan 2018
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal BiomechanicsStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Dikkaya, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500523
- Sponsor's protocol ID
- 11134
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 18 Apr 2018
- Results posted
- 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 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Biomechanical Properties in Pregnancy
- ClinicalTrials.gov ID
- NCT03500523
- Acronym / sponsor ID
- 11134
- Conditions
- Corneal Biomechanics, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 18 Apr 2018 (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.
57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were enrolled in the study. All subjects had a detailed ophthalmologic examination including the best corrected visual acuity with a Snellen chart, slit- lamp biomicroscopic evaluation, and indirect fundoscopy. The biomechanical properties Corneal Hysteresis, Corneal resistance factor, corneal compensated intraocular pressure and Goldmann-correlated intraocular pressure values were measured with ORA (Ocular Response Analyzer, software version 1.02, Reichert, Inc.) Central corneal thickness was measured with a built-in ultrasonic pachymeter attached to the ORA device.Axial length , Anterior chamber depth , and keratometry readings were acquired with an ocular biometer (IOLMaster; Carl-Zeiss Meditec, Inc.) before CCT determinations had been taken. Results of these parameters were compared between pregnant group and healthy control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-study group | Experimental | Diagnostic Test: corneal biomechanical propertiesstudy group: pregnant women |
| 2-control group | Experimental | Diagnostic Test: corneal biomechanical propertiescontrol group: healthy non pregnant women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria included history of intraocular surgery or refractive surgery, history of glaucoma or glaucoma suspicion, contact lens wear, systemic autoimmune disease or diabetes and usage of eye drop and oral contraceptives.
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 |
|---|---|---|
| corneal biomechanical propertiesWe want to investigate changes of corneal biomechanical properties during pregnancy. The Ocular Response Analyzer (ORA) evaluate the in vivo corneal biomechanical properties in form of corneal hysteresis (CH) and corneal resistance factor (CRF) | Diagnostic test | 1-study group, 2-control group |
Primary outcome
changes of corneal hysteresis during pregnancy
Time frame: three months
we analyzed the biomechanical properties of the cornea in terms of corneal hysteresis (mmHg) by using ocular response analyzer device in healthy pregnant women and compared the data with non pregnant women.
changes of corneal resistance factor during pregnancy
Time frame: three months
we analyzed the biomechanical properties of the cornea in terms of corneal resistance factor (mmHg) by using ocular response analyzer device in healthy pregnant women and compared the data with non pregnant women.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corneal biomechanical properties in people with Corneal Biomechanics and Pregnancy, run by Medipol University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Apr 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of corneal hysteresis during pregnancy (time frame: three months). The study lists 2 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 18 Apr 2018.