Autonomic Nervous System Activity and Normal Tension Glaucoma

NCT01192061 | Completed

• 1 other identifier: N N402 165637
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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 and vascular dysregulation may be involved in the pathogenesis of normal tension glaucoma (NTG). Defective cardiovascular neuroregulation has been advocated as a possible one of the main systemic contributing factors in the etiology of NTG. Based on the results of previous studies, the hypothesis has been posed that patients with NTG have an impaired diurnal heart rate variability (HRV) or high activity of the sympathetic component of autonomic nervous system (ANS) and endothelial dysfunction. Impaired balance of ANS, resulting in increased demand for oxygen in the tissues and subsequent low threshold of hypoxia in all organs (including the eye) can be an important link in the pathogenetic pathway of NTG, making the optic nerve more sensitive to small and short-term changes in perfusion pressure and prone to damage even under a statistically "normal" intraocular pressure (IOP). The aim of this study is to evaluate the activity and characteristics of the following systems: the central ANS (through a 24-hour analysis of heart rate variability and blood pressure), peripheral vascular system (through the analysis of the post-occlusive hyperemia reaction within the distal part of left upper limb) and the local retrobulbar circulation as measured by color Doppler imaging (CDI) in patients with NTG and healthy volunteers. The correlations between all above systems, as well as between them and the structural and functional parameters of the optic nerve, and the retina in both groups will be also analyzed.

Conditions

Normal Tension Glaucoma

Keywords

autonomic nervous system; heart rate variability; blood pressure variability; retrobulbar hemodynamics; vascular dysregulation

Outcome Measures

Primary Outcomes (1)

• Time and spectral-domain measures of heart rate variability

  standard deviation of normal to normal RR intervals (SDNN), standard deviation of normal to normal RR intervals index (SD SD), root mean square of succesive differences (RMS-SD), percentage of normal to normal RR interval, greater than 50 ms (pNN50), low-frequency component (LF), high frequency component (HF), LF/HF) ratio

  baseline

Secondary Outcomes (7)

• retrobulbar hemodynamic parameters of ophthalmic (OA), central retinal (CRA) and short ciliary posterior arteries (SCPA)

  baseline

• measures of blood pressure (BP) diurnal variability

  baseline

• parameters of postocclusive hyperemia response

  baseline

• optical coherence tomography parameters of optic nerve head

  baseline

• optical coherence tomography parameters of the retinal nerve fibre layer (RNFL)

  baseline

Study Arms (2)

Normal tension glaucoma group

Control group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NTG group: out-patient clinic of the Ophthalmology Department of the Military Medical Institute (MMI), control group: hospital stuff, family and friends of hospital stuff and patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead
• Polish Academy of Sciences: collaborator
• Indiana University School of Medicine: collaborator
• Medical University of Warsaw: collaborator

Study Sites (1)

Military Medical Institute

Warsaw, 04-141, Poland

Location

Related Publications (4)

• Wierzbowska J, Wierzbowski R, Stankiewicz A, Robaszkiewicz J. [Autonomic nervous system and primary open angle glaucoma--pathogenetic and clinical correlations]. Klin Oczna. 2009;111(1-3):75-9. Polish.

  PMID: 19517852 BACKGROUND

• Brown CM, Dutsch M, Michelson G, Neundorfer B, Hilz MJ. Impaired cardiovascular responses to baroreflex stimulation in open-angle and normal-pressure glaucoma. Clin Sci (Lond). 2002 Jun;102(6):623-30.

  PMID: 12049615 BACKGROUND

• Riccadonna M, Covi G, Pancera P, Presciuttini B, Babighian S, Perfetti S, Bonomi L, Lechi A. Autonomic system activity and 24-hour blood pressure variations in subjects with normal- and high-tension glaucoma. J Glaucoma. 2003 Apr;12(2):156-63. doi: 10.1097/00061198-200304000-00011.

  PMID: 12671471 BACKGROUND

• Kashiwagi K, Tsumura T, Ishii H, Ijiri H, Tamura K, Tsukahara S. Circadian rhythm of autonomic nervous function in patients with normal-tension glaucoma compared with normal subjects using ambulatory electrocardiography. J Glaucoma. 2000 Jun;9(3):239-46. doi: 10.1097/00061198-200006000-00007.

  PMID: 10877375 BACKGROUND

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Joanna Wierzbowska, MD, PhD

  Military Medical Institute, Department of Ophthalmology, 128 Szaserow Str. 04-141 Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: August 31, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 25, 2011

Record last verified: 2011-01

Locations

PL (1)