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IOP Elevation for Glaucoma

Q: What is the total patient population that this experiment includes?

Indeed. According to clinicaltrials.gov, the trial first advertised on March 7th 2018 is currently seeking 150 volunteers from 2 locations for participation. The study was last edited on March 10th 2022.

Q: Is this research only open to those 18 years of age and older?

This study necessitates enrollees to be between 18 and 90 years old. For those under the age of majority, there is a single clinical trial available, while elderly patients have access to nine such studies.

Q: Does this clinical trial offer enrollment to participants at the present moment?

That is correct. Data posted on clinicaltrials.gov confirms that the research project, which was initially published on March 7th 2018, is currently recruiting individuals for participation. 150 people need to be enlisted from two sites for this experiment.

Q: Is there an opportunity to become involved in this research project?

This clinical trial is recruiting 150 subjects, aged between 18 and 90, with intraocular pressure (IOP). Furthermore, to be eligible for the study they must fulfill <a href="https://www.withpower.com/clinical-trials/all">all</a> of the following criteria: an absence of family history (first degree relative) of <a href="https://www.withpower.com/clinical-trials/glaucoma">glaucoma</a>; either an IOP between 25 to 30 mmHg with central corneal thickness &#x3C; 550µm or a difference ≥ 0.2 in cup to disc ratio between eyes; normal appearing optic discs and RNFL on dilated fundus examination; no record of IOP >22 mmHg; normal Swedish interactive thresholding algorithm (SITA)

N/A

Recruiting

Led By Gadi Wollstein, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Glaucoma with glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma, and two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits

Glaucoma suspects with normal visual field as defined above and either IOP between 25 to 30 mmHg with central corneal thickness < 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Awards & highlights

Study Summary

This trial will help researchers learn more about how pressure in the eye leads to vision loss in glaucoma, and whether the optic nerve or liquid chamber is more damaged in the process.

Who is the study for?

This trial is for healthy volunteers with normal vision and no family history of glaucoma. Participants should have a normal visual field, no past high eye pressure over 22 mmHg, and standard perimetry tests within the normal range. They can't join if they've had certain eye surgeries or conditions like diabetes with retinopathy that affect the eyes.Check my eligibility

What is being tested?

The study aims to understand how increased intraocular pressure (IOP) contributes to glaucoma by examining its effect on the optic nerve head (ONH) and lamina cribrosa (LC). It's a prospective study where IOP will be intentionally modulated in participants to observe mechanical responses.See study design

What are the potential side effects?

Since this trial involves increasing intraocular pressure as an intervention rather than testing a drug, side effects may include discomfort in the eyes, potential temporary vision changes, or risk of inducing damage similar to glaucomatous injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have glaucoma with specific eye nerve damage and failed vision field tests.

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I am at risk for glaucoma with normal vision but have high eye pressure or significant differences in the optic nerve appearance between my eyes.

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I am healthy and have no close relatives with glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of the deformation of the lamina cribrosa in glaucoma suspect, in response to increasing intraocular pressure.

Assessment of the deformation of the lamina cribrosa in glaucomatous eyes in response to increasing intraocular pressure.

Assessment of the deformation of the lamina cribrosa in healthy eye in response to increasing intraocular pressure.

Trial Design

3Treatment groups

Active Control

Group I: Glaucoma suspectsActive Control1 Intervention

oEither IOP between 25 to 30 mmHg with central corneal thickness < 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes.

Group II: Healthy VolunteersActive Control1 Intervention

No family history (first degree relative) of glaucoma.

Group III: GlaucomaActive Control1 Intervention

Rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,576 Total Patients Enrolled

8 Trials studying Glaucoma

1,699 Patients Enrolled for Glaucoma

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,402,007 Total Patients Enrolled

42 Trials studying Glaucoma

13,401 Patients Enrolled for Glaucoma

Gadi Wollstein, MDPrincipal InvestigatorNYU Langone Health

2 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Glaucoma

100 Patients Enrolled for Glaucoma

Media Library

Glaucoma suspects Clinical Trial Eligibility Overview. Trial Name: NCT03400137 — N/A

Glaucoma Research Study Groups: Glaucoma suspects, Healthy Volunteers, Glaucoma

Glaucoma Clinical Trial 2023: Glaucoma suspects Highlights & Side Effects. Trial Name: NCT03400137 — N/A

Glaucoma suspects 2023 Treatment Timeline for Medical Study. Trial Name: NCT03400137 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total patient population that this experiment includes?

"Indeed. According to clinicaltrials.gov, the trial first advertised on March 7th 2018 is currently seeking 150 volunteers from 2 locations for participation. The study was last edited on March 10th 2022."

Answered by AI

Is this research only open to those 18 years of age and older?

"This study necessitates enrollees to be between 18 and 90 years old. For those under the age of majority, there is a single clinical trial available, while elderly patients have access to nine such studies."

Answered by AI

Does this clinical trial offer enrollment to participants at the present moment?

"That is correct. Data posted on clinicaltrials.gov confirms that the research project, which was initially published on March 7th 2018, is currently recruiting individuals for participation. 150 people need to be enlisted from two sites for this experiment."

Answered by AI

Is there an opportunity to become involved in this research project?

"This clinical trial is recruiting 150 subjects, aged between 18 and 90, with intraocular pressure (IOP). Furthermore, to be eligible for the study they must fulfill all of the following criteria: an absence of family history (first degree relative) of glaucoma; either an IOP between 25 to 30 mmHg with central corneal thickness < 550µm or a difference ≥ 0.2 in cup to disc ratio between eyes; normal appearing optic discs and RNFL on dilated fundus examination; no record of IOP >22 mmHg; normal Swedish interactive thresholding algorithm (SITA)"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IOP Elevation Study

2018. "IOP Elevation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03400137.

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