Isometric Exercise in NTG

NCT03921372 | Completed DMC

• 1 other identifier: IsometricProtocol2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. It has been shown that flicker light-induced vasodilatation of retinal veins is diminished in patients with glaucoma. Also previous studies indicate that the blood flow autoregulation is impaired in patients with glaucoma. Therefor the ocular perfusion pressure can not be maintained stable during changes of the systemic arterial blood pressure. Laser speckle flowgraphy (LSFG) represents a non-invasive method to quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of microcirculation of the optic disc in Japanese glaucoma patients. Study Objectives: To assess the changes in LSFG parameters in patients with normal tension glaucoma, compared to healthy subjects during flicker light stimulation and isometric exercises.

Conditions

Mean Blur Ratio

Keywords

Normal tension glaucoma

Outcome Measures

Primary Outcomes (1)

• Change in mean blur rate

  5 minutes

Study Arms (2)

Normal Tension Glaucoma (NTG)

EXPERIMENTAL

Patients with diagnosed NTG

Diagnostic Test: Isometric exercise

Healthy Control Subjects

EXPERIMENTAL

Subjects with no sign of glaucoma, Age and sex matched

Diagnostic Test: Isometric exercise

Interventions

Isometric exercise DIAGNOSTIC_TEST

Squatting for 5 minutes

Healthy Control Subjects; Normal Tension Glaucoma (NTG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• a) Study population: patients with normal tension glaucoma
• History of ocular or systemic disease causing optic nerve damage
• History of IOP greater than 21 mm Hg (corrected by CCT)
• Participation in a clinical trial in the 3 weeks preceding the study
• Ocular surgery (including intravitreal injection) during the 3 months preceding the study
• Ametropia \> 6 Dpt
• Smoking
• pre- or perimenopausal women
• Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. optic nerve head drusen, tilted disc, etc.)
• Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading \> 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
• Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
• Blood donation in the 3 weeks preceding the study
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Ocular infection or clinically significant inflammation
• Pregnancy, planned pregnancy or lactating

Sponsors & Collaborators

• Augenabteilung Allgemeines Krankenhaus Linz: lead

Study Sites (1)

AKh Linz

Linz, Upper Austria, 4021, Austria

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthias Bolz, Prof.

  Allgemeines Krankenhaus Linz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: July 26, 2018
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)