Clinical Validation of New OCT System

NCT01809704 | Completed

• 1 other identifier: DC-03267
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 3

Brief Summary

To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus

Conditions

Subjects Presenting With Normal or With Ocular Pathology

Outcome Measures

Primary Outcomes (1)

• Retinal Thickness

  Day 1

Study Arms (3)

Normal

Normal results from clinical exam and free of ocular pathology.

Glaucoma

Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.

Retina

Clinical exam results consistent with retina pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that are Normal, or shows signs of Glaucoma or Retinal Ocular Pathology.

You may qualify if:

• Subjects 18 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects presenting at the site with normal eyes (eyes without pathology)
• IOP ≤ 21 mmHg bilaterally
• BCVA 20/40 or better bilaterally
• Both eyes must be free of eye disease

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging
• Subject with ocular media not sufficiently clear to obtain acceptable OCT images
• HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 1%
• HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 33% or false positives \> 25%, or false negatives \> 25%
• Presence of any ocular pathology except for cataract
• Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning
• Narrow angle
• History of leukemia, dementia or multiple sclerosis
• Concomitant use of hydroxychloroquine and chloroquine
• Subjects 18 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects presenting at the site with glaucoma
• BCVA 20/40 or better in the study eye
• HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 1% in the study eye
• Subjects unable to tolerate ophthalmic imaging

Sponsors & Collaborators

• Topcon Medical Systems, Inc.: lead

Study Sites (3)

Hamilton Glaucoma Center

La Jolla, California, 92093, United States

Location

Murray Fingeret

Jamaica, New York, 11425, United States

Location

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

Study Officials

• Michael Sinai, PhD

  Director of Clinical Marketing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 13, 2013
• Study Start: February 25, 2013
• Primary Completion: July 3, 2013
• Study Completion: July 3, 2013
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

US (3)