Recruiting

Observational Study

Sponsor:

Optos, PLC

Code:

NCT02091700

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

Indocyanine Green ICG

Study Details

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

Study ID

NCT02091700

Start date

Mar, 2017

Status verified date

Mar, 2017

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Normals

Subjects with normal visual and retinal function will be enrolled

Interventions

Indocyanine Green ICG

Primary outcome measure

  • Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Cathy Ellis, BS, MT

210-697-2036cathy@mcoaeyecare.com

Locations

Medical Center Ophthalmology Associates

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Cathy Ellis, BS, MT

210-697-2036cathy@mcoaeyecare.com

Tamara Urias

201-697-2036turias@mcoaeyecare.com

Principal Investigator:

Michael Singer, MD

More Information

Sponsor

Optos, PLC

Last update posted

Mar 13, 2017

Last verified

Mar, 2017

Keywords

  • Normal
  • Healthy
  • Normal healthy patient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Optos, PLC on 2017-03-13.