RECRUITING

Adaptive Optics Retinal Imaging

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Conditions

Glaucoma, Primary Open Angle

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology.

Official Title

Adaptive Optics Retinal Imaging

Quick Facts

Study Start:2018-01-22
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05370287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Are 21 years of age or older.
  2. 2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam).
  3. 3. Have the ability to understand and sign an informed consent.
  4. 4. Have been diagnosed with POAG (cohort 2).
  1. 1. Are under 21 years of age.
  2. 2. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).
  3. 3. Have visual correction outside of the range +4 diopters (D) to -8 D.
  4. 4. Have a history of adverse reaction to mydriatic drops.
  5. 5. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG).
  6. 6. Have any health conditions that would contraindicate oxygen supplementation, including chronic obstructive pulmonary disease (COPD), emphysema, asthma, or any other obstructive or restrictive lung disease (oxygen challenge participants only).
  7. 7. Have a dependency on oxygen support or a baseline oxygen saturation \<95% (oxygen challenge participants only).
  8. 8. Have tested positive for COVID-19 at initial enrollment or have acute or chronic photophobia as a result of contraction.
  9. 9. Are working under the direct supervision of Dr. Hammer.

Contacts and Locations

Study Contact

Daniel X Hammer, Ph.D.
CONTACT
301-796-9320
daniel.hammer@fda.hhs.gov
Zhuolin Liu, Ph.D.
CONTACT
301-796-7914
zhuolin.liu@fda.hhs.gov

Principal Investigator

Daniel X Hammer, Ph.D.
PRINCIPAL_INVESTIGATOR
Food and Drug Administration (FDA)

Study Locations (Sites)

Food and Drug Administration
Silver Spring, Maryland, 20993
United States

Collaborators and Investigators

Sponsor: Food and Drug Administration (FDA)

  • Daniel X Hammer, Ph.D., PRINCIPAL_INVESTIGATOR, Food and Drug Administration (FDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-22
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2018-01-22
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Glaucoma, Primary Open Angle