Isometric Exercise in NTG

• ClinicalTrials.gov Identifier: NCT03921372
• Recruitment Status: Completed
• First Posted: April 19, 2019
• Last Update Posted: April 19, 2019
• Sponsor: Augenabteilung Allgemeines Krankenhaus Linz
• Information provided by (Responsible Party): Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz

Tracking Information

• First Submitted Date: April 17, 2019
• First Posted Date: April 19, 2019
• Last Update Posted Date: April 19, 2019
• Actual Study Start Date: July 26, 2018
• Actual Primary Completion Date: February 25, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 17, 2019): Change in mean blur rate [ Time Frame: 5 minutes ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Isometric Exercise in NTG
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Mean Blur Ratio

Intervention

Diagnostic Test: Isometric exercise

Squatting for 5 minutes

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2019): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 25, 2019
• Actual Primary Completion Date: February 25, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT03921372
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz
• Study Sponsor: Augenabteilung Allgemeines Krankenhaus Linz
• Collaborators: Not Provided

Investigators

• Principal Investigator: Matthias Bolz, Prof.; Allgemeines Krankenhaus Linz

• PRS Account: Augenabteilung Allgemeines Krankenhaus Linz
• Verification Date: April 2019