Back to resultsModifiable Factors and Glaucoma - RCT
Primary Purpose
Intraocular Pressure
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Pressure
Eligibility Criteria
Inclusion Criteria:
- Patients with glaucoma.
Exclusion Criteria:
- Not able to attend follow-up
- Contraindication for treatment or follow-up
Sites / Locations
- The E.Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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. patients are instructed to continue prescribed medical therapy.
Outcomes
Primary Outcome Measures
Intraocular pressure
Secondary Outcome Measures
Illness perception questionnaire results
Full Information
NCT ID
NCT02972749
First Posted
November 20, 2016
Last Updated
December 31, 2017
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02972749
Brief Title
Modifiable Factors and Glaucoma - RCT
Official Title
Modifiable Factors in the Management of Glaucoma - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention. patients are instructed to continue prescribed medical therapy.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Following 1 month of treatment
Secondary Outcome Measure Information:
Title
Illness perception questionnaire results
Time Frame
Following 1 month of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with glaucoma.
Exclusion Criteria:
Not able to attend follow-up
Contraindication for treatment or follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asaf Achiron, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The E.Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Modifiable Factors and Glaucoma - RCT
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