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Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)

Primary Purpose

Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCT
Sponsored by
Heidelberg Engineering GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.
  • Black or African-American 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).

Minimum requirements are:

  • Retina completely included in image frame,
  • Quality Score ≥ 20 in the stored ART mean images, and
  • For ONH-R scan: Center position error ≤ 100 μm.

Sites / Locations

  • University California San Diego
  • Assil Eye Institute
  • Mid Florida Eye Center Clinic
  • Illinois Eye Institute, Illinois College of Optometry
  • St Albans Community Living, Center, Queens Campus
  • SUNY College of Optometry
  • Ophthalmic Consultants of Long Island-Valley Stream
  • Wills Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Normal healthy Volunteers

Arm Description

OCT imaging

Outcomes

Primary Outcome Measures

Bruch-Membrane-Opening - Minimum Rim Width (µm)
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)

Secondary Outcome Measures

Full Information

First Posted
May 18, 2016
Last Updated
August 30, 2023
Sponsor
Heidelberg Engineering GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02785029
Brief Title
Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
Official Title
Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
difficulty in recruiting older subjects
Study Start Date
June 2016 (Actual)
Primary Completion Date
May 2023 (Actual)
Study Completion Date
July 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heidelberg Engineering GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes.
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 African-American 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal healthy Volunteers
Arm Type
Experimental
Arm Description
OCT imaging
Intervention Type
Device
Intervention Name(s)
OCT
Primary Outcome Measure Information:
Title
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Description
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Time Frame
Baseline
Title
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Description
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Time Frame
Baseline
Title
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Description
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Black or African-American 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). Minimum requirements are: Retina completely included in image frame, Quality Score ≥ 20 in the stored ART mean images, and For ONH-R scan: Center position error ≤ 100 μm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balwantray Chauhan, OD
Organizational Affiliation
Department of Ophthalmology and Visual Sciences Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Assil Eye Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mid Florida Eye Center Clinic
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Illinois Eye Institute, Illinois College of Optometry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
St Albans Community Living, Center, Queens Campus
City
Jamaica
State/Province
New York
ZIP/Postal Code
11425
Country
United States
Facility Name
SUNY College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Ophthalmic Consultants of Long Island-Valley Stream
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11581
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)

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