Modifiable Factors and Glaucoma - RCT

December 31, 2017 updated by: Wolfson Medical Center

Modifiable Factors in the Management of Glaucoma - a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Holon, Israel, 58100
        • The E.Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with glaucoma.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
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.
No Intervention: Control
No intervention. patients are instructed to continue prescribed medical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: Following 1 month of treatment
Following 1 month of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Illness perception questionnaire results
Time Frame: Following 1 month of treatment
Following 1 month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Asaf Achiron, MD, Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 31, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0127-16-WOMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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