ObseRvation of PeripHEral rEtinal Morphology in Normals (ORPHEE2)

ObseRvation of PeripHEral rEtinal Morphology in Normal

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Indocyanine Green ICG

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • Medical Center Ophthalmology Associates
      • Contact: Tamara Urias; Phone Number: 2239 201-697-2036; Email: turias@mcoaeyecare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal subjects with no known retinal disease or choroidal disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normals; Subjects with normal visual and retinal function will be enrolled	Other: Indocyanine Green ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Optos, PLC
• Collaborators: Medical Center Ophthalmology Associates San Antonio, Texas
• Investigators: Principal Investigator: Michael Singer, MD, Medical Center Ophthalmology Associates

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Healthy; Normal; Normal healthy patient
• Other Study ID Numbers: OPT1010