NCT03391518

Brief Summary

The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

December 30, 2017

Last Update Submit

December 30, 2017

Conditions

Low Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in ONH blood flow induced by water drinking test

    ONH blood flow evaluated by laser speckle flowgraphy

    baseline, after 15, 30 and 45 minutes

Interventions

Water drinking testPROCEDURE

Ingestion of 800 ml water in less than 5 minutes.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software)
  • IOP ≤ 21mmHg without therapy
  • normal open angle in a gonioscopic examination
  • age \> 40 years

You may not qualify if:

  • IOP \> 21 mmHg in patients' history
  • ametropia \> 6 diopters
  • cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification
  • presence of corneal opacities
  • uncontrolled hypertension with systolic blood pressure (SBP) \> 165mmHg and/or diastolic blood pressure (DBP) \> 100mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKh Linz

Linz, Upper Austria, 4021, Austria

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2017

First Posted

January 5, 2018

Study Start

February 5, 2017

Primary Completion

December 4, 2017

Study Completion

January 31, 2018

Last Updated

January 5, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)