- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972749
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
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.
Sponsor
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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