Status:

RECRUITING

Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects

Lead Sponsor:

Medical University of Vienna

Conditions:

Glaucoma, Open-Angle

Normal Tension Glaucoma

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Glaucoma is characterized by a progressive loss of retinal ganglion cells (RGCs) leading to optic nerve head (ONH) damage and associated visual field defects. The main risk factor for glaucoma is elev...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Patients with primary open angle glaucoma
  • Diagnosis of manifest primary open angle glaucoma defined as pathological optic disc appearance
  • Glaucoma hemifield test outside normal limits
  • Untreated IOP ≥ 21 mmHg on at least three measurements in the medical history
  • Mean deviation in the visual field test is less than or equal 10dB (for one group) OR more than 10dB (for the other group)
  • Patients with normal tension glaucoma
  • Diagnosis of manifest normal tension glaucoma defined as pathological optic disc appearance
  • Glaucoma hemifield test outside normal limits
  • No evidence of untreated IOP \> 20 mmHg in the medical history
  • Mean deviation in the visual field is less than or equal 10dB (for one group) OR more than 10dB (for the other group)
  • Patients with ocular hypertension
  • Normal ophthalmic findings except presence of ocular hypertension defined as untreated IOP ≥ 21 mmHg on at least three measurements in the medical history
  • No signs of glaucomatous damage in the optic disc
  • or the glaucoma hemifield test
  • Healthy control subjects
  • Normal ophthalmic findings
  • IOP \< 20 mmHg on least three measurements
  • No evidence of increased IOP in the medical history
  • No signs of glaucomatous damage in the optic disc
  • or the glaucoma hemifield test
  • Exclusion criteria
  • History of a severe medical condition as judged by the clinical investigator
  • Abuse of alcoholic beverages
  • Smoker
  • Participation in a clinical trial in the 3 weeks preceding the study
  • Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure
  • Intraocular surgery within the last 6 months
  • Ocular inflammation or infection within the last 3 months
  • History of epilepsia
  • Diabetes mellitus
  • Untreated hypertension with systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 95 mmHg
  • Pregnancy
  • Planned pregnancy or lactating

Exclusion

    Key Trial Info

    Start Date :

    December 1 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT03870230

    Start Date

    December 1 2017

    End Date

    March 1 2026

    Last Update

    May 23 2025

    Active Locations (1)

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    1

    Department of Clinical Pharmacology, Medical University of Vienna

    Vienna, Austria

    Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects | DecenTrialz