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Isometric Exercise in NTG

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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

Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE July 26, 2018
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
Change in mean blur rate [ Time Frame: 5 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isometric Exercise in NTG
Official Title  ICMJE Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Patients With Normal Tension Glaucoma
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Mean Blur Ratio
Intervention  ICMJE Diagnostic Test: Isometric exercise
Squatting for 5 minutes
Study Arms  ICMJE
  • Experimental: Normal Tension Glaucoma (NTG)
    Patients with diagnosed NTG
    Intervention: Diagnostic Test: Isometric exercise
  • Experimental: Healthy Control Subjects
    Subjects with no sign of glaucoma, Age and sex matched
    Intervention: Diagnostic Test: Isometric exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2019)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 25, 2019
Actual Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921372
Other Study ID Numbers  ICMJE IsometricProtocol2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz
Study Sponsor  ICMJE Augenabteilung Allgemeines Krankenhaus Linz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias Bolz, Prof. Allgemeines Krankenhaus Linz
PRS Account Augenabteilung Allgemeines Krankenhaus Linz
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP