Glaucoma
Conditions
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.
Interventions
None listed
Sponsors
Heidelberg Engineering GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoints | 3 months | 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. |
| Bruch's Membrane Opening - Minimum Rim Area, Global | 3 months | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normals No eye disease. | 303 |
| Total | 303 |
Baseline characteristics
| Characteristic | Normals |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 108 Participants |
| Age, Categorical Between 18 and 65 years | 195 Participants |
| Gender Female | 150 Participants |
| Gender Male | 153 Participants |
| Race/Ethnicity, Customized | 303 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 303 |
| serious Total, serious adverse events | 0 / 303 |
Outcome results
Primary
Bruch's Membrane Opening - Minimum Rim Area, Global
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers | Bruch's Membrane Opening - Minimum Rim Area, Global | 1339.3 microns^2 | Standard Deviation 197.7 |
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers | Primary Endpoints | peri-papillary RNFL thickness, 12mm circle scan | 97.2 microns | Standard Deviation 9.2 |
| Healthy Volunteers | Primary Endpoints | Macula parameters have not been analyzed | NA microns | — |
| Healthy Volunteers | Primary Endpoints | peri-papillary RNFL thickness, 14mm circle scan | 83.9 microns | Standard Deviation 7.9 |
| Healthy Volunteers | Primary Endpoints | peri-papillary RNFL thickness, 16mm circle scan | 73.9 microns | Standard Deviation 7 |
| Healthy Volunteers | Primary Endpoints | Bruch's Membrane Opening - Minimum Rim Width, glob | 336.1 microns | Standard Deviation 51.6 |