ObseRvation of PeripHEral rEtinal Morphology in Normals

• Conditions: Healthy
• Interventions: Other: Indocyanine Green ICG

• Registration Number: NCT02091700
• Lead Sponsor: Optos, PLC

Brief Summary

To develop a database of the peripheral choroidal circulation using ultra widefield (UWF) imaging. This database will serve as a quantitative reference tool for the comparison of subjects to a database of known normal subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Status Verified: 2017-03
• Study Start: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-13
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects older than 20 years old with good general health.
• Subject is capable of giving consent.
• The subject is able and willing to comply with the study procedures.
• Subjects with ocular media clear enough to allow good quality ocular imaging.
• Normal subjects with no known retinal or choroidal disease.

Exclusion Criteria

• Subjects under 20 years old.
• Subjects with contraindications to dilation.
• Subjects with a history of epilepsy.
• Subjects with a known allergy to iodine, shellfish or intra-venous x-ray contrast dyes.
• Subjects who are or who may be pregnant.
• Subjects with past history of any vitreoretinal disease or surgery such as retinal detachment, epiretinal membrane, or vitreous hemorrhage.
• Subjects with any ocular condition that interferes with good quality image acquisition, such as corneal opacities, cataract, and dense vitreous hemorrhage.
• Subjects with any evidence of any retinal or optic nerve disease including glaucoma.
• Subjects with any anterior segment disease with the exception of common ocular surface disorders (blepharitis, dry eye).
• Subjects with medical conditions that interfere with the subject's compliance to study procedures such as inability of the subject to maintain steady head or eye positioning as in patients of ataxia or nystagmus.
• Subjects with a history of Diabetes, uncontrolled blood pressure (defined as systolic >/= 160mmHg and/or diastolic >/= 90 mmHg), and Vascular Disease (cardiovascular, peripheral vascular, or cerebrovascular).
• Subjects on vasodilators.
• Subject's refusal.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normals	Indocyanine Green ICG	Subjects with normal visual and retinal function will be enrolled

Primary Outcome Measures

Name	Time	Method
Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging	1 day

Secondary Outcome Measures

Name	Time	Method
Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging	1 day

Trial Locations

Locations (1)

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States