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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT01192061
Eligibility Criteria:
Inclusion Criteria:
NTG group
* both gender
* early to moderate NTG
* without significant cardiac or pulmonary conditions. Glaucoma is diagnosed on the basis of a glaucomatous appearance of the optic disc (cup-to-disc ratio greater than 0.6 or an interocular cup-to-disc ratio asymmetry greater than or equal to 0.2, and at least one of the following abnormalities: thinning of the rim, notching, nerve fiber layer defects, or peripapillary atrophy), correlating with visual field defects in two consecutive central 24-2 program of Humphrey threshold perimetry, according to the European Glaucoma Society (EGS) diagnostic criteria (abnormal glaucoma hemifield test or cluster of three non-edge contiguous points at the \<5% level on the pattern deviation plot with at least one point at the \<1% level, with \< 25% fixation losses and false positives and false negatives responses). Early and moderately glaucomatous loss is defined according to the Hodapp et al. classification, based on the Mean Defect (MD) index of visual fields less than - 6 dB (decibels) and - 12 dB but more than -6 dB, respectively, and on the basis of a vertical cup/disc ratio less than 0.8.
Control group
* both gender
* age and gender-matched
* without glaucoma
* without significant cardiac or pulmonary conditions.
Exclusion Criteria:
* ocular hypertension
* primary open angle glaucoma (high pressure glaucoma, IOP\>21mmHg)
* secondary open angle glaucoma
* angle closure glaucoma
* history of eye surgery
* history of eye trauma
* myopia above -6.0 diopters (D)
* corneal dystrophies
* uncontrolled arterial hypertension
* atrial fibrillation
* atrial flutter
* pacemaker
* history of cardiac arrest
* vasovagal syndrome
* diabetes mellitus
* primary damage to the autonomic nervous system
* Shy-Drager syndrome
* encephalomyelitis, multiple sclerosis
* brain and spinal cord tumors
* renal failure
* carotid sinus hypersensitivity syndrome carotid sinus
* carotid artery stenosis
* pregnancy
* breast-feeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01192061
Study Brief:
Protocol Section:
NCT01192061