Retinal and Choroidal Microvascular Changes During Pregnancy Period Detected With Optical Coherence Tomography Angiography

NCT04950855 | Terminated DMC

• 1 other identifier: Study1
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy Related

Keywords

Pregnancy; Tomography, Optical Coherence; Choroid; retina

Outcome Measures

Primary Outcomes (2)

• Choroidal thickness

  Choroidal thickness is measured by optical coherence tomography

  40 weeks

• Retinal thickness

  Retinal thickness is measured by optical coherence tomography

  40 weeks

Secondary Outcomes (4)

• Foveal avascular zone(FAZ) area measurement

  40 weeks

• Retinal vascular density

  40 weeks

• Retinal nerve fiber layer thickness

  40 weeks

• Ganglion cell layer measurement

  40 weeks

Study Arms (2)

Pregnant Women

Healty pregnant women between 18-45 years,with no history of eye surgery and systemical disease.In 1st , 2nd and 3rd trimesters the measurements will be repeated

Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

Control Group

Healty non-pregnant women between 18-45 years with no history of eye surgery and systemical disease.

Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

Interventions

Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon) DIAGNOSTIC_TEST

Optical coherence tomography optical coherence tomography angiography

Also known as: Pachymetry, Otorefractometry, Tonometry, Blood Pressure Measurement

Control Group; Pregnant Women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Healthy pregnant women Age \> 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tomography, Optical Coherence; Corneal Pachymetry; Tonometry, Ocular; Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques, Cardiovascular; Physical Examination

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 6, 2021
• Study Start: June 26, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)