An observational study in Preeclampsia (PE), Hypertension ,Pregnancy and Retinal Microvascular Changes, sponsored by Muğla Sıtkı Koçman University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Muğla Sıtkı Koçman University · Observational
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.
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
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.
903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's planned enrollment of 90 is below the median of 160 across 389 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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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).
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.
Exclusion Criteria:
- 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.
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.
Pregnant 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 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 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.
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.
Time frame: through study completion, an average of 1 year
Foveal Avascular Zone (FAZ) Area
Measurement of the foveal avascular zone (FAZ) area using OCTA imaging to assess potential microvascular alterations associated with preeclampsia.
Time frame: through study completion, an average of 1 year
Choriocapillaris Flow Deficits
Quantitative evaluation of flow void areas within the choriocapillaris layer using OCTA imaging to assess potential alterations in choroidal microcirculation.
Time frame: through study completion, an average of 1 year
Peripapillary Vessel Density
Assessment of vessel density in the peripapillary retinal region using OCTA imaging to evaluate possible microvascular changes associated with preeclampsia.
Time frame: through study completion, an average of 1 year
Retinal Layer Thickness
Measurement of retinal layer thickness parameters using Optical Coherence Tomography (OCT) to identify structural retinal changes related to microvascular alterations.
Time frame: through study completion, an average of 1 year
Plan to share: No
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