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

Last updated: February 6, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Retina

Treatment

Low Vision Rehabilitation (LVR)

Emotion Regulation Therapy (ERT)

Clinical Study ID

NCT06651736
HUM00246479
1R01EY035016-01A1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with vision impairment with IRD etiology

  • Must have had a clinical exam with an IRD specialist within the three months ofassignment to Arm

  • Have had a Goldmann visual field that was tested with III-4e isopter within the lastyear

  • Have a disability greater than zero theta in any of the domains of Michigan RetinalDystrophy Questionnaire (MRDQ)

  • Have an indication from the IRD specialist that the ocular condition will notdeteriorate over the next 1- year

  • Able to participate in 10 weeks of ERT sessions while being physically located inMichigan (these will take place in the first 10 months of the study)

Exclusion

Exclusion Criteria:

  • Having other ocular comorbidities including those associated with an IRD such ascontrol of cystoid macular edema (CME)

  • Functional needs regarding low vision (i.e. activities of daily living) have beenadequately addressed per a study low vision specialist

  • Current mental health therapy

  • The participant must not have an elevated suicidal intention (SI) or suicide riskbased on Patient Health Questionnaire (PHQ-9) further information collected atscreening (If suicidal intentions are identified, the study staff will complete thesuicide protocol (per protocol)

  • 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

  • Inability to complete study task requirements

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Low Vision Rehabilitation (LVR)
Phase:
Study Start date:
January 13, 2025
Estimated Completion Date:
November 24, 2028

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

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