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Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Month and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests a new handheld OCT device, which takes pictures of the retina, the light-sensing layer at the back of the eye. The device lines itself up for imaging. The study is for healthy adult volunteers and adult and child patients at Duke Eye Center.

The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Healthy volunteers must be older than 18 and able and willing to agree to join.
  • Healthy volunteers must have no known eye problems except focusing problems, such as needing glasses.
  • Adult patients must be older than 18, attend Duke Eye Center eye clinics, and be able and willing to agree to join.
  • For adult patients, a health care provider who knows the study plan must agree that study staff may contact them.
  • Child patients must be younger than 18 and attend Duke Eye Center eye clinics or have a medically needed eye exam under anesthesia there. Anesthesia is medicine that puts them to sleep for the exam.
  • For child patients, a health care provider who knows the study plan must agree that staff may contact the parent or legal guardian.
  • A child's parent or legal guardian must be able and willing to give permission for the child to join.

Who can't join

  • Healthy volunteers cannot be students or employees directly supervised by the study researchers.
  • Healthy volunteers cannot have had problems with pupil dilation, which means widening the dark center of the eye.
  • Healthy volunteers who are pregnant cannot join if they will receive drops to widen their pupils.
  • Adult and child patients cannot have a health or eye problem that prevents an eye exam or retina imaging, such as clouding of the eye's clear front surface or lens.
  • Children cannot join if their parent or legal guardian cannot or will not give permission.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Group 1: Healthy adult volunteers * Subject is able and willing to consent to study participation * Subject is more than 18 years of age * Healthy adult volunteers without known ocular issues other than refractive error * Group 2: Adult patients in ophthalmology clinics * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject * Subject is able and willing to consent to study participation * Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics * Group 3: Pediatric participants in ophthalmology clinics * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian * Parent/legal guardian is able and willing to consent to study participation * Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center Exclusion Criteria: * Group 1: Healthy adult volunteers * Students or employees under direct supervision of the investigators * Subjects with prior problems with pupil dilation * Pregnant woman if receiving dilating drops * Group 2: Adult patients in ophthalmology clinics * Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract) * Group 3: Pediatric participants in ophthalmology clinics * Parent/legal guardian unwilling or unable to provide consent * Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Study sites (1)

NC