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

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

Tracking Information

• First Submitted Date: May 18, 2016
• First Posted Date: May 27, 2016
• Last Update Posted Date: July 29, 2020
• Actual Study Start Date: June 2016
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2018)

• Bruch-Membrane-Opening - Minimum Rim Width (µm) [ Time Frame: Baseline ]
  Bruch-Membrane-Opening - Minimum Rim Width (µm)
• Bruch-Membrane-Opening - Minimum Rim Area (µm^2) [ Time Frame: Baseline ]
  Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
• Peripapillary Retinal Nerve Fibre Layer Thickness (µm) [ Time Frame: Baseline ]
  Peripapillary Retinal Nerve Fibre Layer Thickness (µm)

Original Primary Outcome Measures (submitted: May 24, 2016)

• Bruch-Membrane-Opening - Minimum Rim Width (µm) [ Time Frame: Baseline ]
• Bruch-Membrane-Opening - Minimum Rim Area (µm^2) [ Time Frame: Baseline ]
• Peripapillary Retinal Nerve Fibre Layer Thickness (µm) [ Time Frame: Baseline ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Glaucoma
• Intervention: Device: OCT

Study Arms

Experimental: Normal healthy Volunteers

OCT imaging

Intervention: Device: OCT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 24, 2016): 249
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2021
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02785029
• Other Study ID Numbers: S-2015-1-aa
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Heidelberg Engineering GmbH
• Study Sponsor: Heidelberg Engineering GmbH
• Collaborators: Not Provided

Investigators

• Principal Investigator: Balwantray Chauhan, OD; Department of Ophthalmology and Visual Sciences Dalhousie University

• PRS Account: Heidelberg Engineering GmbH
• Verification Date: July 2020