RECRUITING

Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases

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 purpose of this study is to understand if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) that experience emotional distress related to participants' vision loss. The study team hypothesize that treatment with LVR will produce measurable functional gains and that these effects will be enhanced by ERT-linked improvement among the subgroup of IRD patients with elevated vision-related anxiety.

Official Title

Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases

Quick Facts

Study Start:2025-01-13
Study Completion:2028-11-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06651736

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with vision impairment with IRD etiology
  2. * Must have had a clinical exam with an IRD specialist within the three months of assignment to Arm
  3. * Have had a Goldmann visual field that was tested with III-4e isopter within the last year
  4. * Have a disability greater than zero theta in any of the domains of Michigan Retinal Dystrophy Questionnaire (MRDQ)
  5. * Have an indication from the IRD specialist that the ocular condition will not deteriorate over the next 1- year
  6. * Able to participate in 10 weeks of ERT sessions while being physically located in Michigan (these will take place in the first 10 months of the study)
  1. * Having other ocular comorbidities including those associated with an IRD such as control of cystoid macular edema (CME)
  2. * Functional needs regarding low vision (i.e. activities of daily living) have been adequately addressed per a study low vision specialist
  3. * Current mental health therapy
  4. * The participant must not have an elevated suicidal intention (SI) or suicide risk based on Patient Health Questionnaire (PHQ-9) further information collected at screening (If suicidal intentions are identified, the study staff will complete the suicide protocol (per protocol)
  5. * If the participant is using medication for mental health or psychiatry concerns, participants must be on a stable dose of the medication (1-month of taking), otherwise will be excluded
  6. * Inability to complete study task requirements

Contacts and Locations

Study Contact

Jessica Stout
CONTACT
734-763-5590
jrstout@umich.edu

Principal Investigator

K. Thiran Jayasundera, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48105
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • K. Thiran Jayasundera, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2025-01-13
Study Completion Date2028-11-24

Study Record Updates

Study Start Date2025-01-13
Study Completion Date2028-11-24

Terms related to this study

Keywords Provided by Researchers

  • Low Vision Rehabilitation
  • Emotional Regulation Therapy
  • Vision-related anxiety

Additional Relevant MeSH Terms

  • Inherited Retinal Diseases