Lifestyle Changes for Glaucoma

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Medical students, prisoners, pregnant women

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how lifestyle changes, such as altering posture and drinking water, affect eye pressure in individuals with glaucoma and other conditions. Researchers aim to determine if these changes can cause spikes in eye pressure that might challenge eye health. The trial includes different groups: those with certain types of glaucoma, those with autonomic dysfunction (conditions affecting automatic body functions like heart rate), and healthy individuals. Suitable participants include those diagnosed with open-angle glaucoma, normal-pressure glaucoma, or autonomic dysfunction, as well as those without glaucoma. As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle impacts on eye health.

Do I need to stop my current medications for this glaucoma trial?

The trial information does not specify if you need to stop taking your current medications. It's best to ask the trial organizers for more details.

What prior data suggests that these lifestyle changes are safe for glaucoma patients?

Research has shown that changing posture can affect eye pressure in people with glaucoma, which is significant because eye pressure changes can influence glaucoma progression. Studies have documented these posture changes as generally safe for participants.

Regarding water consumption, studies indicate it can temporarily raise eye pressure. However, this increase is typically small and returns to normal within about 30 minutes. The water drinking test is often used in glaucoma studies to observe eye pressure reactions.

Both posture changes and water consumption have been extensively studied and are generally well-tolerated by participants. Existing research indicates no major safety concerns with these activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach to managing glaucoma through lifestyle changes, specifically postural changes and water drinking. Unlike conventional treatments like medications or surgery that primarily aim to lower eye pressure, this trial investigates how simple, everyday actions might help control intraocular pressure and improve eye health. By examining how different body positions and hydration levels affect eye pressure, the trial could uncover non-invasive strategies that complement existing treatments. This could mean more accessible, cost-effective options for people with glaucoma or those at risk.

What evidence suggests that postural change and water drinking could be effective for glaucoma?

This trial will explore how lifestyle changes, such as postural adjustments and water intake, affect eye pressure in individuals with glaucoma. Research has shown that changes in body position can significantly impact eye pressure in people with glaucoma. Participants with open-angle glaucoma will have their intraocular pressures measured during postural changes. Additionally, a water-drinking test, previously used to predict daily eye pressure fluctuations, will be assessed in the trial. High eye pressure during this test might indicate a risk of vision problems. These findings suggest that managing sitting or standing positions and fluid intake could help control eye pressure spikes, which is crucial for people with glaucoma. ^{4 6 7 8 9}

Who Is on the Research Team?

Karen Joos, MD,PhD

Principal Investigator

Vanderbilt Eye Institute

Are You a Good Fit for This Trial?

This trial is for individuals with open-angle glaucoma or normal-pressure glaucoma, as well as those with autonomic dysfunction. Healthy people can also join. Medical students, prisoners, and pregnant women are not eligible to participate.

Inclusion Criteria

You have a dysfunction in your autonomic nervous system.

Healthy individuals.

I have been diagnosed with normal-pressure glaucoma.

Exclusion Criteria

Prisoners

You are pregnant.

Medical students cannot participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Assessment

Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes and water drinking

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Postural change
• Water drinking

Trial Overview The study investigates how drinking water and changing body posture might affect the pressure inside the eye (IOP) in people with different types of glaucoma or autonomic dysfunction compared to healthy individuals.

How Is the Trial Designed?

Group I: Subjects with normal-pressure glaucoma Experimental Treatment 2 Interventions

Subjects with open-angle glaucoma damage following a glaucoma specialist's examination without ever an intraocular pressure recording greater than 21 mm Hg. .1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes 2\. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Group II: Subjects with autonomic dysfunction Experimental Treatment 2 Interventions

Subjects with known autonomic dysfunction diagnoses as defined by the General Clinical Research Center (GCRC) such as pure autonomic failure, Postural orthostatic tachycardia syndrome (POTS), and Multiple System Atrophy( MSA). 1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes 2. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Group III: Primary open-angle glaucoma subjects Experimental Treatment 2 Interventions

Subjects diagnosed with primary open-angle glaucoma following a glaucoma specialist's examination. 1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes 2. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Group IV: Normal subjects Active Control 2 Interventions

Subjects without evidence of glaucoma or autonomic dysfunction. ..1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes 2\. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Lifestyle modifications, such as weight loss, regular exercise, reduced alcohol intake, and dietary changes, are safe and effective treatments for hypertension in elderly patients, yet they are often underutilized by healthcare providers.

These lifestyle changes not only lower blood pressure but also decrease the risk and severity of related health issues, making them a preferable option compared to medication, with minimal contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evidence for Lifestyle Modification in Lowering Blood Pressure in the Elderly. Stanton, JA., Lowenthal, DT.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10776530/

Effect of Different Postures on Intraocular Pressure in Open ... This study aims to investigate the pattern of intraocular pressure (IOP) changes in different postures among patients with open-angle glaucoma (OAG).

2. cureus.com cureus.com/articles/407613-posture-induced-intraocular-pressure-changes-after-ex-press-implantation-versus-medical-therapy-in-primary-open-angle-and-normal-tension-glaucoma-a-retrospective-study

Posture-Induced Intraocular Pressure Changes After Ex ... Posture-induced intraocular pressure (IOP) changes have been associated with glaucoma progression, and certain filtering surgeries reportedly ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667376225000149

Review The impact of intraocular pressure fluctuations on ... Glaucoma patients exhibit substantially more pronounced IOP fluctuations compared to healthy individuals, even when the mean IOP remains within the normal range ...

4. journals.lww.com journals.lww.com/njcp/fulltext/2022/25040/posture_induced_intraocular_pressure_changes_among.4.aspx

Posture-Induced Intraocular Pressure Changes among ... To determine the effect of postural changes on intraocular pressure (IOP) among newly diagnosed patients with primary open-angle glaucoma (POAG).

5. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2128683

Comparison of Posture-Induced Intraocular Pressure ... - IOVS To compare the posture-induced IOP changes in medically treated eyes with those in surgically treated eyes having open-angle glaucoma (OAG) and low IOP.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020849/

The impact of intraocular pressure fluctuations on the ... Cataract surgery reduces intraocular pressure but not posture-induced intraocular pressure changes in patients with angle-closure glaucoma.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9801584/

Posture-induced changes in intraocular pressure after ab ... Several studies have reported that IOP fluctuation is an independent risk factor for glaucoma progression [6, 7], and some have shown that IOP fluctuations ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0226915

Acute effects of posture on intraocular pressure | PLOS One This study represents data from thousands of IOP measurements and provides insight for future studies that consider postural change in relation ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1350946224000685

The relationship between intraocular pressure and glaucoma Intraocular pressure (IOP) is the most important modifiable risk factor for glaucoma and fluctuates considerably within patients over short and long time ...