Study Comparing the P200TxE and P200DTx

NCT ID: NCT03964831

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2020-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study evaluates image quality between two devices.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultra widefield image capture

Group Type OTHER

P200TxE

Intervention Type DEVICE

The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

P200DTx

Intervention Type DEVICE

The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

P200TxE

The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

Intervention Type DEVICE

P200DTx

The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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;
2. Subjects who can follow the instructions by the clinical staff at the clinical site,
3. Subjects who agree to participate in the study;
4. Subjects diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable images;
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Optos, PLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OPT1035

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Coloured-light in Retinitis Pigmentosa.
NCT06224114 NOT_YET_RECRUITING NA
Nidek RS3000 Comparative Study
NCT01384487 COMPLETED
Adaptive Optics Retinal Imaging
NCT02317328 RECRUITING
Comparing 3 Imaging Systems
NCT05022615 COMPLETED
Pain Perception at Laser Treatment
NCT01033968 COMPLETED PHASE4
Dual Wavelength OCT
NCT03843840 COMPLETED