RECRUITING

CLAD Deconvolved PERG Responses in Glaucoma Patients

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

Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.

Official Title

CLAD Deconvolved PERG Responses in Glaucoma Patients

Quick Facts

Study Start:2023-06-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06388096

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:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 to 85 years, inclusive
  2. 2. Refractive errors within -5 to +3 diopters
  3. 3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
  4. 4. Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability \< 15% on all indices, normality \> 5% on all global indices in two consecutive sessions 6 months apart)
  5. 5. Minimum untreated Intraocular pressure IOP of 15 mm Hg
  6. 6. Glaucoma Suspect Status defined as one or more of the following:
  7. * Glaucomatous optic disc appearance (vertical cup-to-disc ratio \[C/D\] ≥0.5
  8. * Cup disc ratio asymmetry ≥0.2
  9. * Localized thinning of the disc
  10. * Presence or history of splinter disc hemorrhage
  11. * Moderately increased IOP (\>21 to \<28 mm Hg).
  12. * Family history of vision loss for glaucoma
  1. 1. Age-related macular degeneration
  2. 2. Diabetes
  3. 3. Parkinson's disease
  4. 4. Multiple sclerosis
  5. 5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  6. 6. Pregnant or nursing women.
  7. 7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
  8. 8. An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
  9. 9. An OCT abnormal enough in a pattern consistent with glaucoma.

Contacts and Locations

Study Contact

Jonathon A Toft-Nielsen, PhD
CONTACT
305-668-6102
jtoftnielsen@jorvec.com
Edward Miskiel, PhD
CONTACT
305-688-6102
emiskiel@jorvec.com

Study Locations (Sites)

University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Jorvec Corp.

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 Date2023-06-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Glaucoma

Additional Relevant MeSH Terms

  • Glaucoma, Suspect