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ObseRvation of PeripHEral rEtinal Morphology in Normals (ORPHEE2)

Optos logo

Optos

Status

Unknown

Conditions

Healthy

Treatments

Other: Indocyanine Green ICG

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT02091700
OPT1010

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Normals
Description:
Subjects with normal visual and retinal function will be enrolled
Treatment:
Other: Indocyanine Green ICG

Trial contacts and locations

1

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Central trial contact

Cathy Ellis, BS, MT

Data sourced from clinicaltrials.gov

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