GlaucomaNCT03912584

Study Comparing the P200TE and the P200TxE in Glaucoma Patients

A study testing P200TE and P200TxE in people with Glaucoma, run by Optos, PLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study evaluates the image quality between two OCT devices. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Glaucoma
What is being tested?: P200TE and P200TxE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 29 Apr 2019to 30 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Medical Center Ophthalmology Associates
San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients

The study evaluates the image quality between two OCT devices.

Read the detailed 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.

Conditions: Glaucoma
Being tested: P200TE, P200TxE
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P200TEDevice
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
P200TxEDevice
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Study groups in NCT03912584
Study group	Role	What they receive
Optical Coherence Tomographer	Other	Not described Receives: Device: P200TE; Device: P200TxE

What is being measured

The primary outcome is the main question the study is designed to answer.

Qualitative B-Scan Assessment
Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good.
The four point scale is defined as follows:
0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan.
1. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility.
2. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility.
3. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.
Measured: 1 day (start: April 29, 2019 - completed: April 30, 2019)

Secondary outcomes (1)

Number of Participants With Adverse Events
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 201930 Apr 2019

First posted11 Apr 2019
Study start29 Apr 2019
Primary completion30 Apr 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03912584
Sponsor's protocol ID: OPT1038
Status last verified: Sep 2022
First submitted: 9 Apr 2019
Last updated: 23 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients
ClinicalTrials.gov ID: NCT03912584
Acronym / sponsor ID: OPT1038
Conditions: Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Optos, PLCIndustry (pharma, biotech, devices)
Study start: 29 Apr 2019 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 11 Apr 2019 (actual)
Results: Posted 23 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study evaluates the image quality between two OCT devices.

Detailed 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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Optical Coherence Tomographer	Other	Device: P200TE, Device: P200TxE

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
P200TEThe P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.	Device	Optical Coherence Tomographer
P200TxEThe P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.	Device	Optical Coherence Tomographer

Primary outcome

Qualitative B-Scan Assessment
Time frame: 1 day (start: April 29, 2019 - completed: April 30, 2019)
Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good. The four point scale is defined as follows: 0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan. 1. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility. 2. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility. 3. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.

1 secondary outcome

Number of Participants With Adverse Events
Time frame: 1 day

Results and safety

Results posted to the registry on 23 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Optical Coherence Tomographer	10	10

Primary outcome: Qualitative B-Scan Assessment

Time frame: 1 day (start: April 29, 2019 - completed: April 30, 2019). Mean (Standard Deviation). Unit: Mean score on a scale (0-3)

Measure	Optical Coherence Tomographer - P200TE n = 10	Optical Coherence Tomographer - P200TxE n = 10
Average score (0-3) for clinical utility and clinical quality Indy (P200TxE) Posterior scans	–	2.78 (.45)
Average score (0-3) for clinical utility and clinical quality Indy (P200TxE) Peripheral scans	–	2.77 (.46)
Average score (0-3) for clinical utility and clinical quality Monaco (P200TE) scans	2.08 (.64)	–

Population analysed: The average score (0-3) for clinical utility and clinical quality for the P200TxE does not apply to P200TE scans, and the average score (0-3) for clinical utility and clinical quality for the P200TE does not apply to P200TxE scans. 10 subjects were imaged in total, however clinical utility and quality were measured separately for the three outcomes described below (1. Indy posterior scans, 2. Indy peripheral scans, 3. Monaco scans).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Optical Coherence Tomographer: P200TE	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Optical Coherence Tomographer: P200TxE	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing P200TE and P200TxE in people with Glaucoma, run by Optos, PLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative B-Scan Assessment (time frame: 1 day (start: April 29, 2019 - completed: April 30, 2019)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.