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ObseRvation of PeripHEral rEtinal Morphology in Normals

ObseRvation of PeripHEral rEtinal Morphology in Normal

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02091700
Acronym
ORPHEE2
Enrollment
30
Registered
2014-03-19
Start date
2017-03-31
Completion date
2017-07-31
Last updated
2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Normal, Healthy, Normal healthy patient

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.

Interventions

OTHERIndocyanine Green ICG

Sponsors

Medical Center Ophthalmology Associates San Antonio, Texas
CollaboratorUNKNOWN
Optos, PLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging1 day

Secondary

MeasureTime frame
Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging1 day

Countries

United States

Contacts

Primary ContactCathy Ellis, BS, MT
cathy@mcoaeyecare.com210-697-2036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026