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Preeclampsia (PE)PE-OCTANCT07874191

Retinal and Choroidal Microcirculation in Preeclampsia: An OCTA Study

An observational study of Preeclampsia (PE) and Hypertension ,Pregnancy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Preeclampsia is a multisystemic and multifactorial disorder that complicates pregnancy and is characterized by new-onset hypertension after the 20th week of gestation accompanied by proteinuria or systemic findings such as renal dysfunction, hepatic dysfunction, pulmonary edema, thrombocytopenia, or neurological… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2026to 1 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: The study population will consist of women aged 18-45 years who meet the eligibility criteria and voluntarily agree to participate in the study. Participants in the preeclampsia group and healthy pregnant control group will be recruited from patients followed at the Department of Obstetrics and Gynecology during routine outpatient visits. The healthy non-pregnant control group will consist of volunteers presenting to the Ophthalmology outpatient clinic for routine eye examination and meeting the inclusion criteria. All participants will undergo ophthalmologic examination and retinal imaging using Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA).

Who may be able to join

  • -
  • Female participants aged 18-45 years.
  • Willingness to participate in the study and provision of written informed consent.
  • Absence of ocular media opacities that could interfere with Optical Coherence Tomography (OCT) or Optical Coherence Tomography Angiography (OCTA) imaging (e.g., dense cataract or vitreous hemorrhage).
  • No history of previous ocular surgery.
  • No high refractive error (refractive error greater than ±6 diopters).
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  • Singleton pregnancy for participants in the pregnant groups.
  • Preeclampsia group:
  • Diagnosis of preeclampsia after the 20th week of gestation according to established clinical criteria.
  • No history of chronic hypertension, diabetes mellitus, chronic kidney disease, retinopathy or other ocular diseases, systemic vasculitis, or collagen vascular disease prior to pregnancy.
  • Healthy pregnant control group:
  • Healthy pregnancy without preeclampsia or hypertensive disorders of pregnancy.
  • No history of hypertension, diabetes mellitus, chronic kidney disease, retinopathy or other ocular diseases, systemic vasculitis, or collagen vascular disease.
  • Healthy non-pregnant control group:
  • Healthy non-pregnant women without a history of hypertension, diabetes mellitus, chronic kidney disease, retinopathy or other ocular diseases, systemic vasculitis, or collagen vascular disease.

Who cannot join

  • History of chronic hypertension prior to pregnancy.
  • Diagnosis of diabetes mellitus (DM) or gestational diabetes mellitus (GDM).
  • Presence of chronic kidney disease.
  • History of retinopathy or other ocular diseases, including glaucoma, uveitis, retinal detachment, or macular pathology.
  • Multiple pregnancy (twin pregnancy or higher-order gestation).
  • History of systemic vasculitis or collagen vascular disease.
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  • History of previous ocular surgery.
  • Presence of high refractive error (greater than ±6 diopters).
  • Poor image quality preventing reliable analysis of Optical Coherence Tomography (OCT) or Optical Coherence Tomography Angiography (OCTA) images.
  • Failure to provide written informed consent.
  • Age below 18 years or above 45 years.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

beril kanat, Dr contact

+905334791167

berilneslik@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Muğla Sıtkı Koçman University Training and Research Hospital

    Muğla, Menteşe, 48000

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Quantitative Analysis of Retinal and Choroidal Microcirculation in Preeclampsia Using Optical Coherence Tomography Angiography

Preeclampsia is a multisystemic and multifactorial disorder that complicates pregnancy and is characterized by new-onset hypertension after the 20th week of gestation accompanied by proteinuria or systemic findings such as renal dysfunction, hepatic dysfunction, pulmonary edema, thrombocytopenia, or neurological symptoms including headache and visual disturbances. It represents a significant risk factor for maternal and fetal morbidity and mortality.

In normal pregnancy, trophoblasts invade and dilate the maternal spiral arteries, thereby increasing uteroplacental blood flow. In preeclampsia, however, inadequate trophoblastic invasion leads to defective placentation, resulting in uteroplacental hypoperfusion and ischemia. The hypoxic and ischemic placenta releases anti-angiogenic mediators into the maternal circulation, which disrupt maternal endothelial function. This endothelial dysfunction results in vasoconstriction, microthrombosis, and increased vascular permeability. Consequently, hypertension, renal and hepatic dysfunction, pulmonary edema, and neurological symptoms may develop in maternal organ systems.

Read more

The endothelial dysfunction observed in preeclampsia can also affect the microvascular structures of the eye, leading to circulatory disturbances at the level of the retina and choroid. Disruption of endothelial integrity, together with vasospasm and microthrombus formation, may cause reduced perfusion in the retinal and choroidal microcirculation, forming the basis of the ophthalmic manifestations of preeclampsia. Clinically, this condition may present with visual disturbances, blurred vision, scotomas, retinal edema, and choroidal thickening.

These microvascular changes can be evaluated noninvasively in outpatient settings using Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA). OCT and OCTA allow high-resolution imaging of retinal and choroidal structures and enable quantitative assessment of vascular parameters such as vessel density, the size of the foveal avascular zone (FAZ), and choriocapillaris flow voids. Through these techniques, microvascular hypoperfusion, loss of vascular integrity, and ischemic areas caused by endothelial damage associated with preeclampsia can be objectively identified.

The aim of this study is to evaluate ocular vascular changes associated with preeclampsia using OCT and OCTA

Read the detailed description

Preeclampsia is a multisystem pregnancy disorder characterized by new-onset hypertension after 20 weeks of gestation accompanied by proteinuria or other systemic manifestations such as renal dysfunction, hepatic dysfunction, pulmonary edema, thrombocytopenia, or neurological symptoms. It remains a major cause of maternal and fetal morbidity and mortality worldwide. The underlying pathophysiology of preeclampsia is strongly associated with abnormal placentation and systemic endothelial dysfunction.

During normal pregnancy, trophoblastic invasion of maternal spiral arteries leads to vascular remodeling and increased uteroplacental blood flow. In preeclampsia, however, inadequate trophoblastic invasion results in defective placentation and impaired remodeling of spiral arteries, leading to uteroplacental hypoperfusion and placental ischemia. The hypoxic placenta releases anti-angiogenic and inflammatory mediators into the maternal circulation, which contribute to widespread endothelial dysfunction. This endothelial injury results in vasoconstriction, increased vascular permeability, and microvascular thrombosis affecting multiple maternal organ systems.

Because the retina and choroid share similar microvascular characteristics with other systemic vascular beds and the retina is considered an extension of the central nervous system, ocular circulation may reflect systemic microvascular alterations occurring in preeclampsia. Endothelial dysfunction, vasospasm, and microthrombus formation may impair retinal and choroidal microcirculation, resulting in reduced perfusion and structural vascular changes. Clinically, these alterations may manifest as visual disturbances, blurred vision, scotomas, retinal edema, or choroidal thickening.

Recent advances in Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA) have enabled detailed, noninvasive evaluation of retinal and choroidal microvasculature. OCTA allows high-resolution visualization of retinal vascular networks without the need for contrast agents and enables quantitative assessment of vascular parameters such as retinal vessel density, the size of the foveal avascular zone (FAZ), and choriocapillaris flow deficits. Previous studies have reported alterations in these parameters in patients with preeclampsia; however, differences in imaging protocols and analytical methods have limited the comparability of results across studies.

The aim of the present prospective observational study is to evaluate retinal and choroidal microvascular changes associated with preeclampsia using OCT and OCTA. The study will include three groups: pregnant women diagnosed with preeclampsia after the 20th week of gestation, healthy pregnant women matched for maternal age and gestational age, and healthy non-pregnant women. Quantitative OCT and OCTA parameters including retinal vessel density, FAZ area, and choriocapillaris flow deficits will be analyzed and compared between groups.

Ophthalmic examinations and imaging procedures will be performed in an outpatient clinical setting using standard OCT and OCTA devices. These imaging techniques are noninvasive and do not require direct contact with the eye. The procedure involves light-based scanning of retinal and choroidal tissues and typically takes only a few minutes to complete.

Statistical analyses will be performed using SPSS software. Descriptive statistics will be calculated for all variables, and appropriate statistical tests will be applied to compare quantitative parameters between groups. The findings of this study are expected to contribute to a better understanding of the microvascular effects of preeclampsia and may help identify potential noninvasive ocular biomarkers reflecting systemic endothelial dysfunction in affected pregnancies.

The study will be conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval will be obtained from the institutional ethics committee prior to initiation of the study, and written informed consent will be obtained from all participants.

Keywords
Preeclampsia, Optical Coherence Tomography Angiography, OCTA, Retinal Microcirculation, Choroidal Circulation, Retinal Vessel Density, Foveal Avascular Zone, Choriocapillaris Flow Deficits, Pregnancy
Medical subject headings
Pre-Eclampsia, Hypertension, Pregnancy-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07874191
Study groupRoleWhat they receive
Preeclampsia GroupPregnant women diagnosed with preeclampsia after the 20th week of gestation according to established clinical diagnostic criteria. Participants will undergo ophthalmologic examination and noninvasive retinal imaging using Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA) to evaluate retinal and choroidal microvascular parameters.
Healthy Pregnant Control GroupHealthy pregnant women without hypertensive disorders of pregnancy, matched with the preeclampsia group in terms of maternal age and gestational week. Participants will undergo OCT and OCTA imaging to assess retinal and choroidal microcirculation parameters.
Healthy Non-Pregnant Control GroupHealthy non-pregnant women without systemic or ocular disease. Participants will undergo ophthalmologic examination and OCT/OCTA imaging to evaluate retinal and choroidal microvascular parameters for comparison with pregnant groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retinal Vessel Density

    Quantitative measurement of retinal vessel density in the superficial and deep capillary plexus using Optical Coherence Tomography Angiography (OCTA). Differences in vessel density between the preeclampsia group, healthy pregnant controls, and healthy non-pregnant controls will be evaluated.

    Measured: through study completion, an average of 1 year

  2. Foveal Avascular Zone (FAZ) Area

    Measurement of the foveal avascular zone (FAZ) area using OCTA imaging to assess potential microvascular alterations associated with preeclampsia.

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)
  1. Choriocapillaris Flow Deficits

    Quantitative evaluation of flow void areas within the choriocapillaris layer using OCTA imaging to assess potential alterations in choroidal microcirculation.

    Measured: through study completion, an average of 1 year

  2. Peripapillary Vessel Density

    Assessment of vessel density in the peripapillary retinal region using OCTA imaging to evaluate possible microvascular changes associated with preeclampsia.

    Measured: through study completion, an average of 1 year

  3. Retinal Layer Thickness

    Measurement of retinal layer thickness parameters using Optical Coherence Tomography (OCT) to identify structural retinal changes related to microvascular alterations.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2026
  2. Study start1 Jan 2026
  3. Primary completion29 Dec 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07874191
Sponsor's protocol ID
MSKU-PE-OCTA-2026-01
Acronym
PE-OCTA
Status last verified
Mar 2026
First submitted
5 Oct 2026
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Christou EE, Ong AY, Kiire CA, Primrose N, Tucker WR, Frise C, de Silva SR. Ophthalmic conditions affecting the choroid and retina in pregnancy: An overview of key pathologies. Obstet Med. 2025 Sep 10:1753495X251367092. doi: 10.1177/1753495X251367092. Online ahead of print.

    PubMed 40951770
  • Christou EE, Ong AY, Frise C, Jalil A, Ivanova T, Georgalas I, de Silva SR. Evaluating the Chorioretinal Microcirculation in Preeclampsia with OCT-Angiography: A Narrative Literature Review. J Clin Med. 2025 Jun 2;14(11):3913. doi: 10.3390/jcm14113913.

    PubMed 40507675
  • Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.

    PubMed 32443079

Questions about this trial

What is this clinical trial studying?

An observational study of Preeclampsia (PE) and Hypertension ,Pregnancy, run by Muğla Sıtkı Koçman 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 15 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact beril kanat, Dr (+905334791167, berilneslik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinal Vessel Density (time frame: through study completion, an average of 1 year). 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?

On the ClinicalTrials.gov record for NCT07874191, which also lists 3 linked publications.

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 14 Oct 2026.

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