Glaucoma. Clinical Trial
Official title:
Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
Collect OCT data to evaluate the range and age trend of ocular measurements.
| Status | Completed |
| Enrollment | 322 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | Dalhousie University | Halifax | Nova Scotia |
| Lead Sponsor | Collaborator |
|---|---|
| Heidelberg Engineering GmbH |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |