Treatment for Glaucoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Illinois College of Optometry, Chicago, IL
Glaucoma+2 More
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is a prospective comparative, randomized, single center study to assess agreement and precision of the P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Eligible Conditions

  • Normal
  • Glaucoma
  • Retina Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Limit of Agreement (LOA) between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Precision between the P200TE and predicate device measurements of full retinal thickness.
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
Precision between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

125 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Illinois College of Optometry · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2015First Recorded Clinical Trial
2 TrialsResearching Glaucoma
6 CompletedClinical Trials

Who is running the clinical trial?

Optos, PLCLead Sponsor
12 Previous Clinical Trials
2,399 Total Patients Enrolled
4 Trials studying Glaucoma
292 Patients Enrolled for Glaucoma

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 22 years of age or older.
You are able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens.
You have a BCVA of 20/40 or better (each eye) on the date of the study visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.