NCT01641835

Completed

Optical Coherence Tomography (OCT) Data Collection Study

Heidelberg Engineering GmbH Source

Heidelberg Engineering GmbH

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

S-2012-1 NORM-cc

Study Type

observational

Actual enrollment (reported)

303

Locations

1 country

Sites

1

Timeline

Study Start

July 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2012

Actual (reported)

Study Completion

December 2012

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 303 participants
Study completion date: December 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 13, 2012
Actual (reported)
First Posted
July 17, 2012
Actual (reported)
Primary Completion
December 2012
Actual (reported)
Study Completion
December 2012
Actual (reported)
Results Posted
December 19, 2016
Actual (reported)

Last Updated: December 19, 2016
Status Verified: September 2016
Results QC Date: October 26, 2016
Last Update Submitted: October 26, 2016

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

Age18 Years - 90 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

No eye disease.

You may qualify if:

Subject is not an employee of the eye clinic.

Sponsors & Collaborators

Heidelberg Engineering GmbH
Industrylead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title: Gerhard Zinser, PhD
Organization: Heidelberg Engineering GmbH

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

Publication Agreements

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

Enrollment

303 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Unknown

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Active Not Recruiting

NCT01351779

The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

Unknown

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.

Contact the study team to confirm eligibility.

Alexander Scheuerle, MD

Universitätsaugenklinik, Heidelberg, Germany

PRINCIPAL INVESTIGATOR

Primary Completion

December 2012

Actual (reported)

Study Completion

December 2012

Actual (reported)

Last Updated

December 19, 2016

Results First Posted

December 19, 2016

Record last verified: 2016-09

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01641835
Data provider: ClinicalTrials.gov
Source updated: 2016-12-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:21 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Normals

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations