ObseRvation of PeripHEral rEtinal Morphology in Normals

NCT ID: NCT02091700

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normals

Subjects with normal visual and retinal function will be enrolled

Indocyanine Green ICG

Intervention Type OTHER

Interventions

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Indocyanine Green ICG

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Center Ophthalmology Associates San Antonio, Texas

UNKNOWN

Sponsor Role collaborator

Optos, PLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Ophthalmology Associates

Locations

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Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cathy Ellis, BS, MT

Role: CONTACT

210-697-2036 ext. 2270

Facility Contacts

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Cathy Ellis, BS, MT

Role: primary

210-697-2036 ext. 2270

Tamara Urias

Role: backup

201-697-2036 ext. 2239

Other Identifiers

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OPT1010

Identifier Type: -

Identifier Source: org_study_id

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