N/A
N=303
Optical Coherence Tomography (OCT) Data Collection Study
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01641835 ↗Enrolled (actual)
303
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Primary Endpoints — 97.2; 83.9; 73.9; 336.1 microns
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Heidelberg Engineering GmbH
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Endpoints |
97.2; 83.9; 73.9; 336.1; NA | — |
| PRIMARY Bruch's Membrane Opening - Minimum Rim Area, Global |
1339.3 | — |
Summary
Collect OCT data to evaluate the range and age trend of ocular measurements.
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.
Data sourced from ClinicalTrials.gov (NCT01641835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.