Pregnancy RelatedNCT05175729
Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy
An observational study of Pregnancy Related, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate anterior segment changes during and after pregnancy, and compare them with non pregnant healty women Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Comprehensive Ophthalmologic Examination
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Aug 2022
- 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnan women in their first pregnancy will be followed-up during pregnancy period (first, second, third trimesters) and post partum period. Healthy age-, sex- matched control group will be used to compare
Who may be able to join
- Ages between 20-40 years
- Pregnant women with a gestational age less than 14 weeks in the first examination
- Having no systemic disease before and during pregnancy
- Having a spherical refractive error of less than 4 diopters, and/or had a cylindrical refractive error of less than 2 diopters
Who cannot join
- Having systemic disease, having ocular pathology that may decrease visual acuity
- Usage of systemic drugs or topical ocular drops
- Usage of exogenous hormones and entered menopause
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Hospital
Antalya, Konyaaltı, 07059
About this study
The aim of this study is to evaluate anterior segment changes during and after pregnancy, and compare them with non pregnant healty women
Read the detailed description
Pregnancy is a physiological process in which many systems such as cardiovascular, pulmonary, renal, hematological and visual systems are affected, especially the endocrine system. Many organs, including the eye and orbit, are affected by the physiological interaction between the fetus and the mother. In most pregnant women, these effects are at the physiological level and are temporary; Sometimes it can be pathological and permanent. Hormonal, coagulative and hemodynamic changes are responsible for most of the ocular adaptations. Changes in corneal curvature, sensitivity and thickness are observed during pregnancy. It has been reported that corneal curvature increases with pregnancy, this increase occurs in the last trimester and returns to first trimester values at the end of the breastfeeding period. Although the etiology of this steepening of the cornea has not been clearly clarified, it is thought that it may be due to corneal edema caused by hormonal changes. However, it's not recommended for pregnant women to prescribe contact lenses because their variable keratometric values. A decrease in corneal sensitivity during pregnancy has been detected by esthesiometry in many studies. It decreases especially in the third trimester and returns to normal around the 2nd month after delivery. The corneal thickness measured by pachymeter may increase in pregnant women. some of them had myopic shift. In a study, 83 pregnant women were examined to determine the causes of visual disturbances during pregnancy and postpartum period. Previous studies reported that there was a change in favor of myopia (-0.9±0.3D) during pregnancy and it returned to pre-pregnancy levels in the postpartum period. Unstable refractions were thought to be due to changes in corneal thickness and curvature.
As a result, it was stated that the refractive change was temporary and in favor of myopia. It is recommended to wait up to several weeks postpartum before prescribing new eyeglasses [8].
There are various reports about IOP in normal pregnant women. In most of these studies, a decrease was found in IOP during pregnancy. In a prospective study, a decrease in IOP was found in the second and third trimesters of pregnancy, and it was shown that this change returned in the first month postpartum.
Before planning an anterior segment surgeries such as cataract and refractive surgery, changes in pregnancy should be taken into account and attention should be paid to surgical timing. The aim of this study is to reveal whether there is a change in anterior segment parameters in pregnancy period
- Conditions
- Pregnancy Related
- Being tested
- Comprehensive Ophthalmologic Examination
- Keywords
- Pregnancy, Anterior segment, Corneal Topography, Biometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Ophthalmologic ExaminationDiagnostic test
Also called Corneal Topography, Biometry, Auto refractometry, Non contact tonometry
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters,corneal topography
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Group | First trimester pregnant group would be included and will be followed up in second, third trimesters and after pregnancy Receives: Diagnostic Test: Comprehensive Ophthalmologic Examination | |
| Control group | Age-, sex-matched healthy volunteers Receives: Diagnostic Test: Comprehensive Ophthalmologic Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal thickness
Corneal thickness in mikrometer value
Measured: 40 weeks
Anterior chamber volume
Anterior chamber volume in mm3
Measured: 40 weeks
Anterior chamber depth
Anterior chamber depth in mm
Measured: 40 weeks
Anterior chamber angle
Anterior chamber angle in degree
Measured: 40 weeks
Lens power
in diopters
Measured: 40 weeks
Anterior flat keratometry
in Diopters
Measured: 40 weeks
Steep keratometry
in Diopters
Measured: 40 weeks
Mean keratometry
in Diopters
Measured: 40 weeks
Tonometry
İntraocular pressure measurement in mmHg
Measured: 40 weeks
Best corrected visual acuity assessment
Snellen and logMAR chart
Measured: 40 weeks
Blood pressure measurement
Systemic blood pressure
Measured: 40 weeks
Auto refractometer
Refractive error measurement in diopter
Measured: 40 weeks
Axial length
Axial length in mm
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çisil Erkan Pota, Akdeniz University
- Investigators
- Çisil Erkan Pota, MD, Principal investigator, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175729
- Sponsor's protocol ID
- Study 2
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy
- ClinicalTrials.gov ID
- NCT05175729
- Acronym / sponsor ID
- Study 2
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Anterior segment, Corneal Topography, Biometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 4 Jan 2022 (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.
The aim of this study is to evaluate anterior segment changes during and after pregnancy, and compare them with non pregnant healty women
Detailed description
Pregnancy is a physiological process in which many systems such as cardiovascular, pulmonary, renal, hematological and visual systems are affected, especially the endocrine system. Many organs, including the eye and orbit, are affected by the physiological interaction between the fetus and the mother. In most pregnant women, these effects are at the physiological level and are temporary; Sometimes it can be pathological and permanent. Hormonal, coagulative and hemodynamic changes are responsible for most of the ocular adaptations. Changes in corneal curvature, sensitivity and thickness are observed during pregnancy. It has been reported that corneal curvature increases with pregnancy, this increase occurs in the last trimester and returns to first trimester values at the end of the breastfeeding period. Although the etiology of this steepening of the cornea has not been clearly clarified, it is thought that it may be due to corneal edema caused by hormonal changes. However, it's not recommended for pregnant women to prescribe contact lenses because their variable keratometric values. A decrease in corneal sensitivity during pregnancy has been detected by esthesiometry in many studies. It decreases especially in the third trimester and returns to normal around the 2nd month after delivery. The corneal thickness measured by pachymeter may increase in pregnant women. some of them had myopic shift. In a study, 83 pregnant women were examined to determine the causes of visual disturbances during pregnancy and postpartum period. Previous studies reported that there was a change in favor of myopia (-0.9±0.3D) during pregnancy and it returned to pre-pregnancy levels in the postpartum period. Unstable refractions were thought to be due to changes in corneal thickness and curvature.
As a result, it was stated that the refractive change was temporary and in favor of myopia. It is recommended to wait up to several weeks postpartum before prescribing new eyeglasses [8].
There are various reports about IOP in normal pregnant women. In most of these studies, a decrease was found in IOP during pregnancy. In a prospective study, a decrease in IOP was found in the second and third trimesters of pregnancy, and it was shown that this change returned in the first month postpartum.
Before planning an anterior segment surgeries such as cataract and refractive surgery, changes in pregnancy should be taken into account and attention should be paid to surgical timing. The aim of this study is to reveal whether there is a change in anterior segment parameters in pregnancy period
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Group | – | Diagnostic Test: Comprehensive Ophthalmologic ExaminationFirst trimester pregnant group would be included and will be followed up in second, third trimesters and after pregnancy |
| Control group | – | Diagnostic Test: Comprehensive Ophthalmologic ExaminationAge-, sex-matched healthy volunteers |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnan women in their first pregnancy will be followed-up during pregnancy period (first, second, third trimesters) and post partum period. Healthy age-, sex- matched control group will be used to compare
Key inclusion criteria (4 listed)
- Ages between 20-40 years
- Pregnant women with a gestational age less than 14 weeks in the first examination
- Having no systemic disease before and during pregnancy
- Having a spherical refractive error of less than 4 diopters, and/or had a cylindrical refractive error of less than 2 diopters
Key exclusion criteria (3 listed)
- Having systemic disease, having ocular pathology that may decrease visual acuity
- Usage of systemic drugs or topical ocular drops
- Usage of exogenous hormones and entered menopause
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 |
|---|---|---|
| Comprehensive Ophthalmologic ExaminationAlso: Corneal Topography, Biometry, Auto refractometry, Non contact tonometryMeasurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters,corneal topography | Diagnostic test | Control group, Pregnant Group |
Primary outcome
Corneal thickness
Time frame: 40 weeks
Corneal thickness in mikrometer value
Anterior chamber volume
Time frame: 40 weeks
Anterior chamber volume in mm3
Anterior chamber depth
Time frame: 40 weeks
Anterior chamber depth in mm
Anterior chamber angle
Time frame: 40 weeks
Anterior chamber angle in degree
Lens power
Time frame: 40 weeks
in diopters
Anterior flat keratometry
Time frame: 40 weeks
in Diopters
Steep keratometry
Time frame: 40 weeks
in Diopters
Mean keratometry
Time frame: 40 weeks
in Diopters
Tonometry
Time frame: 40 weeks
İntraocular pressure measurement in mmHg
Best corrected visual acuity assessment
Time frame: 40 weeks
Snellen and logMAR chart
Blood pressure measurement
Time frame: 40 weeks
Systemic blood pressure
Auto refractometer
Time frame: 40 weeks
Refractive error measurement in diopter
Axial length
Time frame: 40 weeks
Axial length in mm
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 9 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Active, not recruiting
Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort
Pregnancy Related
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
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.
Çisil Erkan Pota, MD principal investigator
Akdeniz University Hospital
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 Related, run by Akdeniz 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 4 inclusion and 3 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 9 Aug 2022. 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?
Corneal thickness (time frame: 40 weeks). The study lists 13 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 9 Aug 2022.