Using advanced imaging to analyze retinal vascular diseases
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
NA · Johns Hopkins University · NCT04505618
This study is testing new imaging techniques to see how they can help doctors understand and track the progress of retinal diseases like diabetic retinopathy in both healthy people and those affected by these conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1050 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04505618 on ClinicalTrials.gov |
What this trial studies
This study conducts a prospective, longitudinal analysis of clinical and imaging findings from both healthy individuals and those with retinal vascular diseases. It aims to define diagnostic imaging criteria that indicate changes in disease stage, including progression or regression of conditions like diabetic retinopathy and retinal vein occlusion. Participants will undergo non-invasive imaging procedures, such as Optical Coherence Tomography (OCT) and fundus imaging, to correlate these findings with clinical disease stages and visual acuity. The study will utilize data collected through standard-of-care methods at eye clinics.
Who should consider this trial
Good fit: Ideal candidates include adults with retinal vascular diseases such as diabetic retinopathy or retinal vein occlusion, as well as healthy controls for comparison.
Not a fit: Patients with significant eye diseases, such as glaucoma or age-related macular degeneration, or those with a history of certain systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic criteria for retinal vascular diseases, leading to improved patient management and treatment outcomes.
How similar studies have performed: Other studies utilizing advanced imaging techniques like OCT have shown promise in improving the understanding and management of retinal diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Exclusion Criteria: * Both subjects with diseases and controls: * Children (age\<18) * Pregnant females * Developmentally delayed subjects * Subjects unable to provide informed consent * Inability to cooperate with tests and study instructions * Images with motion artifact or signal strength \< 7 * History of glaucoma * History of age-related macular degeneration * History of any visually significant eye disease * History of proliferative diabetic retinopathy * History of any inflammatory disease * History of heart disease * History of thyroid disease. * Additional criteria for controls: * History of any type of Diabetes Mellitus * History of any type of Hypertension
Where this trial is running
Baltimore, Maryland
- Wilmer Eye Institute — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Amir Kashani, MD, MPH — Johns Hopkins University
- Study coordinator: Amir H Kashani, MD, PhD
- Email: akashan1@jhmi.edu
- Phone: 410-502-2789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential, Retinal Vascular Disorder