Modifiable Factors and Glaucoma - RCT

NCT ID: NCT02972749

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with glaucoma.

Exclusion Criteria

* Not able to attend follow-up
* Contraindication for treatment or follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asaf Achiron, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

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The E.Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0127-16-WOMC

Identifier Type: -

Identifier Source: org_study_id

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