Auto-aligned OCT for Eye Disorders

Durham, NC

N/A

Waitlist Available

Led By Xi Chen, MD, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Group 1: Healthy adult volunteers must be able and willing to consent to study participation and be more than 18 years of age without known ocular issues other than refractive error

Must not have

Group 2: Adult patients in ophthalmology clinics must not have a health or eye condition that precludes eye examination or retinal imaging (such as corneal opacity or cataract)

Group 3: Pediatric participants in ophthalmology clinics must have a parent/legal guardian unwilling or unable to provide consent and must not have a health or eye condition that precludes eye examination or retinal imaging (such as corneal opacity or cataract)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 single imaging sessions at clinical visits over 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new handheld device that can automatically align to take images of the retina in adult volunteers and patients of all ages in a clinic setting."

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Who is the study for?

This trial is for both adults and children with various eye conditions such as Purtscher Retinopathy, optic nerve issues, neuro-ophthalmological disorders, glaucoma, and other retinal diseases. It aims to include volunteers who can undergo imaging with a new handheld device in a clinical setting.Check my eligibility

What is being tested?

The study is testing an advanced version of a handheld OCT (Optical Coherence Tomography) device that automatically aligns itself to capture images of the retina. This pilot study will assess its effectiveness in real-world clinic settings on adult and pediatric patients.See study design

What are the potential side effects?

Since this trial involves non-invasive imaging using an auto-aligned OCT device, there are minimal expected side effects. The primary concern may be discomfort from bright lights or sitting still during the imaging process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18, healthy, willing to participate, and have no eye problems except for needing glasses or contacts.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any health issues that prevent eye exams or imaging.

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My child can undergo an eye exam and does not have conditions like corneal opacity or cataract.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 single imaging sessions at clinical visits over 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 single imaging sessions at clinical visits over 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 single imaging sessions at clinical visits over 2 years for reporting.