Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)

This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Device: Heidelberg Spectralis OCT

Detailed Description

This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anika Bruns; Email: clinical.trials@heidelbergengineering.com

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University California San Diego
    • Santa Monica, California, United States, 90404
      • Assil Eye Institute
    • Santa Rosa, California, United States, 95401
      • North Bay Eye Associates
  • Florida
    • Mount Dora, Florida, United States, 32757
      • Mid Florida Eye Center Clinic
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois Eye Institute, Illinois College of Optometry
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry
    • Valley Stream, New York, United States, 11581
      • Ophthalmic Consultants of Long Island-Valley Stream
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able and willing to undergo the test procedures, give consent, and to follow instructions.
• Signed informed consent
• Age ≥18 to 90.
• Healthy eye without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve. Small drusen are acceptable in older subjects.
• Hispanic decent (self-reported)
• Negative history of glaucoma (not including family history)
• Intraocular pressure ≤21mmHg.
• Best corrected visual acuity ≥20/40.
• Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
• Axial length ≤ 26.0 mm (by optical biometry)
• Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits or not abnormal visual field by judgment of the ophthalmologist / optometrist
• Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
• If both eyes are eligible, both eyes enter the study.

Exclusion Criteria:

• Vulnerable subjects (as defined in ISO 14155 GCP) with the exception of employees of the site, and, if applicable, students of the respective university. Staff that is listed on the delegation form are excluded from participation.
• Subjects unable to read or write
• Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
• Unusable disc stereo photos.
• Inability to undergo the tests.
• Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal healthy volunteers; imaging with Heidelberg Spectralis OCT	Device: Heidelberg Spectralis OCT; OCT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bruch-Membrane-Opening - Minimum Rim Width (µm)	Bruch-Membrane-Opening - Minimum Rim Width (µm)	Baseline
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)	Bruch-Membrane-Opening - Minimum Rim Area (µm^2)	Baseline
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)	Peripapillary Retinal Nerve Fibre Layer Thickness (µm)	Baseline

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Balwantray Chauhan, OD, Department of Ophthalmology and Visual Sciences Dalhousie University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimated): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: S-2015-3-hi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO