Status:
COMPLETED
Autonomic Nervous System Activity and Normal Tension Glaucoma
Lead Sponsor:
Military Institute od Medicine National Research Institute
Collaborating Sponsors:
Polish Academy of Sciences
Indiana University School of Medicine
Conditions:
Normal Tension Glaucoma
Eligibility:
All Genders
30+ years
Brief Summary
Evidence has accumulated that systemic and ocular mechanisms, responsible for regulating blood flow in the area of the optic disc, such as reduced ocular perfusion pressure, abnormal autoregulation an...
Detailed Description
Fifty patients with NTG and 50 age and gender-matched control subjects will be recruited. All patients will be underwent eye examination (medical history, best corrected visual acuity, slit-lamp and s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01192061
Start Date
February 1 2010
End Date
January 1 2011
Last Update
January 25 2011
Active Locations (1)
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1
Military Medical Institute
Warsaw, Poland, 04-141