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

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ClinicalTrials.gov Identifier: NCT02785042
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE May 27, 2016
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)
Official Title  ICMJE Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)
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 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glaucoma
Intervention  ICMJE Device: Heidelberg Spectralis OCT
OCT imaging
Study Arms  ICMJE Experimental: Normal healthy volunteers
imaging with Heidelberg Spectralis OCT
Intervention: Device: Heidelberg Spectralis OCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
249
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Thomas Schulz, PhD +49 6221 64630 thomas.schulz@heidelbergengineering.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02785042
Other Study ID Numbers  ICMJE S-2015-3-hi
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heidelberg Engineering GmbH
Study Sponsor  ICMJE Heidelberg Engineering GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Balwantray Chauhan, OD Department of Ophthalmology and Visual Sciences Dalhousie University
PRS Account Heidelberg Engineering GmbH
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP