Optical Coherence Tomography (OCT) Data Collection Study
This study has been completed.
Information provided by (Responsible Party):
Heidelberg Engineering GmbH
First received: July 13, 2012
Last updated: July 3, 2013
Last verified: July 2013
Collect OCT data to evaluate the range and age trend of ocular measurements.
||Observational Model: Case-Only
Time Perspective: Prospective
||Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
Primary Outcome Measures:
- Primary Endpoints [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641835
|Halifax, Nova Scotia, Canada, B3H 2Y9 |
Heidelberg Engineering GmbH
||Balwantray Chauhan, PhD
||Dalhousie University, Halifax, NS, Canada
||Claude Burgoyne, MD
||Devers Eye Institute, Portland, OR, USA
||Christopher Girkin, MD
||Callahan Eye Foundation Hospital, Birmingham, AL, USA
||Christian Mardin, MD
||Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany
||Alexander Scheuerle, MD
||Universitätsaugenklinik, Heidelberg, Germany
No publications provided
ClinicalTrials.gov processed this record on November 27, 2014
||Heidelberg Engineering GmbH
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 13, 2012
||July 3, 2013
||United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices