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

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ClinicalTrials.gov Identifier: NCT02785029
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: OCT Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
Actual Study Start Date : June 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Normal healthy Volunteers
OCT imaging
 Device: OCT


Outcome Measures
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Primary Outcome Measures :
  1. Bruch-Membrane-Opening - Minimum Rim Width (µm) [ Time Frame: Baseline ]
    Bruch-Membrane-Opening - Minimum Rim Width (µm)

  2. Bruch-Membrane-Opening - Minimum Rim Area (µm^2) [ Time Frame: Baseline ]
    Bruch-Membrane-Opening - Minimum Rim Area (µm^2)

  3. Peripapillary Retinal Nerve Fibre Layer Thickness (µm) [ Time Frame: Baseline ]
    Peripapillary Retinal Nerve Fibre Layer Thickness (µm)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785029


Contacts
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Contact: Thomas Schulz, PhD +49 6221 64630 thomas.schulz@heidelbergengineering.com

Locations
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United States, California
University California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Linda Zangwill, MD         
Principal Investigator: Linda Zangwill, MD         
Assil Eye Institute Completed
Santa Monica, California, United States, 90404
United States, Florida
Mid Florida Eye Center Clinic Completed
Mount Dora, Florida, United States, 32757
United States, Illinois
Illinois Eye Institute, Illinois College of Optometry Completed
Chicago, Illinois, United States, 60616
United States, New York
St Albans Community Living, Center, Queens Campus Completed
Jamaica, New York, United States, 11425
SUNY College of Optometry Completed
New York, New York, United States, 10036
Ophthalmic Consultants of Long Island-Valley Stream Completed
Valley Stream, New York, United States, 11581
United States, Pennsylvania
Wills Eye Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
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Principal Investigator: Balwantray Chauhan, OD Department of Ophthalmology and Visual Sciences Dalhousie University
More Information
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Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT02785029    
Other Study ID Numbers: S-2015-1-aa
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases