Clinical trial NCT04950855: Retinal and Choroidal Microvascular Changes During Pregnancy Period Detected With Optical Coherence Tomography Angiography
Official title: Evaluation of Retinal and Choroidal Microvascular Structures: Comparison With Three Trimesters of Healthy Pregnant Women and Healthy Non-pregnant Women Using Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy Related
Keywords: Pregnancy
Tomography, Optical Coherence
Choroid
retina
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retinal and choroid thickness and retinal angiographic values will be measured in healthy pregnant population (1 time for each trimester,totally 3 times) and healty control group

Brief summary: During pregnancy many physiological changes and adaptations occur.Hormonal, hematological and hemodynamic changes are responsible for most of the ocular adaptations.We are planning to compare the choroid and retinal blood flow values and choroidal thickness of pregnant women and healthy non pregnant women with optical coherence tomography and optic coherence tomography angiography

Detailed description: During pregnancy many physiological changes and adaptations occur such as pulmonary, renal, endocrinological, haematological and visual system changes are happening. In previous studies, retinal and choroidal pregnancy-related changes in blood flow and choroidal thickness have been demonstrated. Optical coherence tomography angiography (OCTA) detects the contrast of motion in the blood flow, detecting the capillary of the retina and choroid.

It is a new functional method that visualizes the retinal networks and outer retina without using dyes.It is a non-invasive method that provides volumetric angiography information. In this study evaluation of the variability of choroidal and retinal blood flow changes and choroidal thickness, between trimesters of pregnancy and the non-pregnant control group is planned. Choroid and Retinal Blood Flow Values and Choroidal thickness in 41 pregnant women in the first trimester and it would be repeated at second and third trimesters. We compare measured values between trimesters and 45 healthy non-pregnant women.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women Age \> 18 years

Exclusion Criteria:

* Systemical disease such as diabetes mellitus or hypertension
* Refractive error; spherical equivalence \> 4 diopters
* Ocular disease or surgery history

Primary outcomes:
measure: Choroidal thickness
timeFrame: 40 weeks
measure: Retinal thickness
timeFrame: 40 weeks
Secondary outcomes:
measure: Foveal avascular zone(FAZ) area measurement
timeFrame: 40 weeks
measure: Retinal vascular density
timeFrame: 40 weeks
measure: Retinal nerve fiber layer thickness
timeFrame: 40 weeks
measure: Ganglion cell layer measurement
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
Study officials:
References: