Triton Reference Database

Healthy Eyes Clinical Trial

Official title:

Topcon DRI OCT Triton Reference Database Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067675
• Other study ID #: Triton RDB
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to collect OCT measurement data on normal healthy eyes.

Description:

The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon DRI OCT Triton based on the percentile points for 1%, 5%, 95%, and 99%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Subjects 18 years of age or older on the date of informed consent

2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

3. Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)

4. IOP = 21 mmHg bilaterally

5. BCVA 20/40 or better bilaterally

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging

2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images

3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%

4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:

1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;

2. Glaucoma hemi-field test "outside normal limits."

5. Narrow angle

6. History of leukemia, dementia or multiple sclerosis

7. Concomitant use of hydroxychloroquine and chloroquine

Related Conditions & MeSH terms

• Healthy Eyes

Intervention

Device:
• Topcon DRI OCT Triton (plus)
OCT Machine used for diagnostic purposes

Locations

Country	Name	City	State
United States	Southern California College of Optometry	Anaheim	California
United States	Illinois College of Optometry	Chicago	Illinois
United States	New York VA	Jamaica	New York
United States	Stat University of New York College of Optometry	New York	New York
United States	Accessoreyes Optometry	Pasadena	California
United States	Fischer Laser Eye Center	Willmar	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal Thickness	The thickness of the macula layer	1 Minute