Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT01641835
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01641835
Study Brief:
Protocol Section:
NCT01641835