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PE-OCTA
Quantitative Analysis of Retinal and Choroidal Microcirculation in Preeclampsia Using Optical Coherence Tomography Angiography
Sponsor study identifier
observational
90
1 country
1
Study Start
January 1, 2026
Actual (reported)Primary Completion
December 29, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2026
Actual (reported)October 5, 2026
Actual (reported)October 14, 2026
Actual (reported)December 29, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
through study completion, an average of 1 year
Choriocapillaris Flow Deficits
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.
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).
Muğla Sıtkı Koçman University Training and Research Hospital
Muğla, Menteşe, 48000, Turkey (Türkiye)
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.
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.
First Submitted
October 5, 2026
First Posted
October 14, 2026
Study Start
January 1, 2026
Actual (reported)Primary Completion
December 29, 2026
Estimatedthrough study completion, an average of 1 year
Peripapillary Vessel Density
through study completion, an average of 1 year
Retinal Layer Thickness
through study completion, an average of 1 year
Contact the study team to confirm eligibility.
Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 14, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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