Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Isometric Exercise in NTG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03921372
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz

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.


Condition or disease Intervention/treatment Phase
Mean Blur Ratio Diagnostic Test: Isometric exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Patients With Normal Tension Glaucoma
Actual Study Start Date : July 26, 2018
Actual Primary Completion Date : February 25, 2019
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal Tension Glaucoma (NTG)
Patients with diagnosed NTG
Diagnostic Test: Isometric exercise
Squatting for 5 minutes

Experimental: Healthy Control Subjects
Subjects with no sign of glaucoma, Age and sex matched
Diagnostic Test: Isometric exercise
Squatting for 5 minutes




Primary Outcome Measures :
  1. Change in mean blur rate [ Time Frame: 5 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Study population: patients with normal tension glaucoma

    • Caucasian men and women aged over 50 years
    • Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study
    • Normal open angle in a gonioscopic examination
    • Presence of glaucomatous optic disc changes in biomicroscopy and
    • Visual field defects in at least two visual field examinations (Reliability criteria: fixation errors < 20%, false positives < 15%, and false negatives < 33%) Or
    • Abnormal circumpapillary retinal nerve fiber layer thinning (RNFL evaluated by OCT)
  2. Control group

    • Men and women aged over 18 years
    • Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study
    • Baseline IOP in both eyes below 21 mm Hg
    • Normal findings in slitlamp and funduscopic examination

Exclusion Criteria:

  • 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

    b) Control group

  • Abnormal RNFL
  • Visual field defects
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921372


Locations
Layout table for location information
Austria
AKh Linz
Linz, Oberösterreich, Austria, 4021
Sponsors and Collaborators
Augenabteilung Allgemeines Krankenhaus Linz
Investigators
Layout table for investigator information
Principal Investigator: Matthias Bolz, Prof. Allgemeines Krankenhaus Linz

Layout table for additonal information
Responsible Party: Matthias Bolz, Prof., Augenabteilung Allgemeines Krankenhaus Linz
ClinicalTrials.gov Identifier: NCT03921372     History of Changes
Other Study ID Numbers: IsometricProtocol2
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz:
Normal tension glaucoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Low Tension Glaucoma
Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases