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IOP Response Monitoring for Glaucoma

N/A
Recruiting
Led By Chaim Wollstein
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
Central thinning of the cornea
Must not have
Diabetes with evidence of retinopathy.
Any intraocular non-glaucomatous ocular disorders.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the changes caused by intraocular pressure in subjects with keratoconus in order to improve our understanding of the role of the lamina in glaucoma pathogenesis.

Who is the study for?
This trial is for people with keratoconus, a condition that thins and reshapes the cornea, who also show signs of potential glaucoma damage. Participants must have had two abnormal eye tests indicating possible glaucoma and be able to give informed consent. Those with cloudy eye media, other eye disorders, diabetes-related eye damage, or certain movement disorders are excluded.
What is being tested?
The study investigates how increased pressure inside the eye affects the optic nerve in patients with keratoconus using various advanced imaging techniques like OCT and Pentacam. It aims to understand if these patients respond differently due to their unique corneal structure.
What are the potential side effects?
Since this trial involves non-invasive imaging tests rather than medication or surgery, side effects are minimal but may include temporary discomfort from bright lights or close contact with the imaging devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have signs of glaucoma in my optic nerve.
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My cornea is thinner in the center.
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I have been diagnosed with keratoconus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes with eye damage.
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I have an eye condition that is not related to glaucoma.
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I do not have eye conditions like strabismus or nystagmus that affect my vision.
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I have cloudiness in parts of my eye like the lens or cornea.
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My vision loss is not due to glaucoma but another neurological reason.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anterior laminar displacement measured in microns
LC measurements measured in microns

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Subjects With KeratoconusActive Control5 Interventions
Group II: Subjects with GlaucomaActive Control5 Interventions

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,455 Total Patients Enrolled
9 Trials studying Glaucoma
5,397 Patients Enrolled for Glaucoma
Chaim WollsteinPrincipal InvestigatorNYU Langone Health

Media Library

IOP Modulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03560609 — N/A
Glaucoma Research Study Groups: Subjects With Keratoconus, Subjects with Glaucoma
Glaucoma Clinical Trial 2023: IOP Modulation Highlights & Side Effects. Trial Name: NCT03560609 — N/A
IOP Modulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03560609 — N/A
~19 spots leftby Nov 2025
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