What is the mechanism of action of this treatment?

Optical Coherence Tomography (OCT) is a non-invasive imaging technique that captures high-resolution cross-sectional images of the retina. For patients with normal eyes, OCT is crucial as it allows for the early detection and monitoring of potential retinal and macular conditions that might not yet present symptoms. By identifying issues such as macular degeneration, diabetic retinopathy, or glaucoma at an early stage, OCT enables timely intervention, which can prevent progression and preserve vision. This proactive approach is essential for maintaining ocular health and preventing vision loss.

What side effects are associated with this type of intervention?

Optical Coherence Tomography (OCT) is a safe, non-invasive imaging test used to capture high-resolution images of the retina. The primary side effects are related to the pupil dilation required for the procedure, which can cause temporary blurred vision, light sensitivity, and difficulty focusing on close objects. Rarely, allergic reactions to the dilating drops may occur. Other treatments or diagnostic procedures used alongside OCT may have their own side effects, such as discomfort or irritation from contact lenses or eye drops.

What prior FDA approvals exist?

FDA-approved treatments for retinal conditions that can be monitored using Optical Coherence Tomography (OCT) include ranibizumab (Lucentis) and bevacizumab (Avastin). These drugs are used to treat neovascular age-related macular degeneration (AMD) by inhibiting vascular endothelial growth factor (VEGF), thereby reducing abnormal blood vessel growth and fluid leakage in the retina. Both drugs have shown efficacy in improving visual acuity and reducing retinal thickness, as observed through OCT imaging.

What other types of research exist?

Promising novel alternatives to Optical Coherence Tomography (OCT) for capturing high-resolution retinal images in normal eyes include combining OCT with fundus photography and scanning laser ophthalmoscopy, as well as the development of ultra-high speed, ultra-high resolution OCT. These advancements enhance the visualization of retinal tissue morphology and may provide more detailed and comprehensive imaging options for patients.

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P200TE US Reference Database Study

N/A

Waitlist Available

Research Sponsored by Optos, PLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to gather eye images from healthy people using a light-based imaging test called OCT. The goal is to create a database of normal eye measurements for a device called P200TE.

Who is the study for?

This trial is for people who are at least 22 years old, can follow the study's procedures, and have signed the consent form. They must have normal eyes with a visual acuity of 20/40 or better but can have certain conditions like cataracts or past eye surgeries that don't affect the back part of the eye.

What is being tested?

The study aims to gather data using Optical Coherence Tomography (OCT) on participants with normal eyesight to create a reference database for a device called P200TE.

What are the potential side effects?

Since this trial involves non-invasive imaging with OCT and does not test any drugs or invasive treatments, there are no expected side effects related to medications. However, discomfort from bright lights during imaging may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GCC Thickness

Optic Nerve Head

RNFL Thickness

+1 more

Secondary study objectives

Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: OCTExperimental Treatment1 Intervention

Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

P200TE

2019

N/A

~370

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Optical Coherence Tomography (OCT) is a non-invasive imaging technique that captures high-resolution cross-sectional images of the retina. For patients with normal eyes, OCT is crucial as it allows for the early detection and monitoring of potential retinal and macular conditions that might not yet present symptoms. By identifying issues such as macular degeneration, diabetic retinopathy, or glaucoma at an early stage, OCT enables timely intervention, which can prevent progression and preserve vision. This proactive approach is essential for maintaining ocular health and preventing vision loss.

Optical coherence tomography findings in patients prior to cataract surgery regarded as unremarkable with ophthalmoscopy.Subthreshold laser treatment for retinal arterial macroaneurysm.