Study Comparing the P200TE and the P200TxE in Glaucoma Patients

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Optos

Status

Completed

Conditions

Glaucoma

Treatments

Device: P200TxE
Device: P200TE

Study type

Interventional

Funder types

Industry

Identifiers

NCT03912584
OPT1038

Details and patient eligibility

About

The study evaluates the image quality between two OCT devices.

Full description

The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.

Enrollment

10 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
  • Subjects who can follow the instructions by the clinical staff at the clinical site,
  • Subjects who agree to participate in the study;
  • Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;

Exclusion criteria

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  • Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
  • Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%;
  • Subjects with history of dementia or multiple sclerosis

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Optical Coherence Tomographer
Other group
Treatment:
Device: P200TE
Device: P200TxE

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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