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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT01614158
Eligibility Criteria:
Inclusion Criteria: - physical, intellectual and linguistic abilities, in order to understand the test requirements
* willingness to comply with the protocol (4 visits)
* 41 - 80 years, informed consent
* acute N-AION (\< 7 d)
* D-BCVA \> 0.1 (2/20)
* RAPD ≥ 0.3 logE steps (neutral density filters) and:
* spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
* isocoria, pupil diameter \> 3 mm
Exclusion Criteria:
* diabetic retinopathy and any other orbital, intracranial or optic nerve disease
* history of epilepsy or significant psychiatric disease
* medications known to affect visual field sensitivity
* infections (e.g. keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drug
* amblyopia
* strabismus
* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings
* cataract with relevant impairment of vision
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or signs of any visual pathway affection other than N-AION
* history or presence of macular disease and / or macular edema
* ocular trauma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01614158
Study Brief:
Protocol Section:
NCT01614158