N/A
N=129
Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Carotid Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT04326842 ↗Enrolled (actual)
129
Serious AEs
1.6%
Results posted
Oct 2020
Primary outcome: Primary: Radical Peripapillary Capillaries Vessel Density — 55.95; 57.24 percentage of vessel
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Carotid artery revascularization procedure (Procedure); Optical coherence tomography angiography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- First Affiliated Hospital of Harbin Medical University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radical Peripapillary Capillaries Vessel Density |
55.95; 57.24 | — |
| PRIMARY Superficial Vascular Complexes Vessel Density |
48.65; 52.22 | — |
| PRIMARY Deep Vascular Complexes Vessel Density |
49.65; 57.50 | — |
| PRIMARY Choriocapillaris Vessel Density |
67.41; 68.74 | — |
| SECONDARY Change of Difference of Mean Transit Time(dMTT) |
-0.22 | — |
| SECONDARY Change of the Ratio of Cerebral Blood Flow(rCBF) |
0.19 | — |
| SECONDARY Changes of Retinal Nerve Fiber Layer |
2.50 | — |
| SECONDARY Changes of Deep Vascular Complexes Vessel Density |
4.00 | — |
| SECONDARY Changes of Radical Peripapillary Capillaries Vessel Density |
1.55 | — |
| SECONDARY Changes of Superficial Vascular Complexes Vessel Density |
1.70 | — |
Summary
This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of carotid artery stenosis
- Age-gender-race-matched controls
Exclusion Criteria
- age 21 mmHg
- VA >logMAR 1.0
- spherical equivalent (SE) between >1.00 or < -6.00 D
- other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis
- major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection
- glaucoma or first-degree relatives with a history of glaucoma; and
- any disease that might cause poor scan quality (image quality <6).
Data sourced from ClinicalTrials.gov (NCT04326842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.