Optical Coherence Tomography (OCT) Data Collection Study

NCT01641835 | Completed Results DMC

• 1 other identifier: S-2012-1 NORM-cc
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

Collect OCT data to evaluate the range and age trend of ocular measurements.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Primary Endpoints

  The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.

  3 months

• Bruch's Membrane Opening - Minimum Rim Area, Global

  3 months

Study Arms (1)

Normals

No eye disease.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No eye disease.

You may qualify if:

• Subject is not an employee of the eye clinic.
• Age ≥18 to 90.
• Able and willing to undergo the test procedures, give consent, and to follow instructions.
• Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
• Caucasian decent (self-reported).
• Negative history of glaucoma.
• Intraocular pressure ≤21mmHg.
• Best corrected visual acuity ≥0.5.
• Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
• Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
• 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.
• When both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures.

You may not qualify if:

• 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.
• Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Gerhard Zinser, PhD
• Organization: Heidelberg Engineering GmbH

Contact@HeidelbergEngineering.com

+4962216463

Study Officials

• Balwantray Chauhan, PhD

  Dalhousie University, Halifax, NS, Canada

  PRINCIPAL INVESTIGATOR

• Claude Burgoyne, MD

  Devers Eye Institute, Portland, OR, USA

  PRINCIPAL INVESTIGATOR

• Christopher Girkin, MD

  Callahan Eye Foundation Hospital, Birmingham, AL, USA

  PRINCIPAL INVESTIGATOR

• Christian Mardin, MD

  Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany

  PRINCIPAL INVESTIGATOR

• Alexander Scheuerle, MD

  Universitätsaugenklinik, Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 19, 2016
• Results First Posted: December 19, 2016

Record last verified: 2016-09

Locations

CA (1)