ObseRvation of PeripHEral rEtinal Morphology in Normals

NCT02091700 | Unknown

• 1 other identifier: OPT1010
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Normal; Healthy; Normal healthy patient

Outcome Measures

Primary Outcomes (1)

• Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging

  1 day

Secondary Outcomes (1)

• Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging

  1 day

Study Arms (1)

Normals

Subjects with normal visual and retinal function will be enrolled

Other: Indocyanine Green ICG

Interventions

Indocyanine Green ICG OTHER

Normals

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal subjects with no known retinal disease or choroidal disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optos, PLC: lead
• Medical Center Ophthalmology Associates San Antonio, Texas: collaborator

Study Sites (1)

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

RECRUITING

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Singer, MD

  Medical Center Ophthalmology Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Ellis, BS, MT

CONTACT

210-697-2036; cathy@mcoaeyecare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (1)