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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anterior laminar displacement measured in microns
LC measurements measured in microns

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
1,363 Previous Clinical Trials
816,286 Total Patients Enrolled
7 Trials studying Glaucoma
1,569 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

Frequently Asked Questions

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

Is this medical investigation still open to new participants?

"Per clinicaltrials.gov, this research trial is currently recruiting participants. It was first advertised on November 15th 2018, and the most recent update to its listing occurred on November 21st 2022."

Answered by AI

Are there any eligibility criteria which must be met in order to participate in this clinical experiment?

"This litigation seeks 130 individuals aged 18-90 years old with glaucoma to participate in the study. Inclusion criteria include ability to give informed consent; clinical diagnosis of keratoconus, central thinning of cornea, abnormal posterior ectasia; Glaucomatous ONH abnormality such as rim thinning, notching and undermining (excavation); two consecutive abnormal SITA standard perimetry tests outside normal limits."

Answered by AI

Is this experiment recruiting subjects aged 45 and over?

"As per the requirements for enrolment, eligible participants must be 18 years old at a minimum and no older than 90."

Answered by AI

To what extent is this research involving participants?

"Right, the details available on clinicaltrials.gov attest to this trial's persistent search for participants. Initially posted in November of 2018 and updated just last month, it seeks 130 volunteers from a single location."

Answered by AI
~8 spots leftby Jul 2024