NCT02972749

Brief Summary

There is growing awareness that environmental factors, behaviors and diet are intimately related to patient health and may play a role in the pathogenesis and progression of glaucoma. Evidence from recent years has shown that some behaviors and environmental factors can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to investigate whether simple and common lifestyle inteventions such as sleeping with a head elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake could affect intraocular pressure and other outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 20, 2016

Last Update Submit

December 31, 2017

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Following 1 month of treatment

Secondary Outcomes (1)

  • Illness perception questionnaire results

    Following 1 month of treatment

Study Arms (2)

Intervention

EXPERIMENTAL

Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.

Behavioral: Intervention

Control

NO INTERVENTION

No intervention. patients are instructed to continue prescribed medical therapy.

Interventions

InterventionBEHAVIORAL

Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with glaucoma.

You may not qualify if:

  • Not able to attend follow-up
  • Contraindication for treatment or follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The E.Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Asaf Achiron, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

IL(1)