Clinical trial NCT01641835: Optical Coherence Tomography (OCT) Data Collection Study
Official title: Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No eye disease.

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

Detailed description: This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary Endpoints
timeFrame: 3 months
measure: Bruch's Membrane Opening - Minimum Rim Area, Global
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University, Halifax, NS, Canada
name: Balwantray Chauhan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Devers Eye Institute, Portland, OR, USA
name: Claude Burgoyne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Callahan Eye Foundation Hospital, Birmingham, AL, USA
name: Christopher Girkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany
name: Christian Mardin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsaugenklinik, Heidelberg, Germany
name: Alexander Scheuerle, MD
role: PRINCIPAL_INVESTIGATOR
References: