Combining vision rehabilitation with emotional therapy for patients with inherited retinal diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) for individuals suffering from inherited retinal diseases (IRDs) who experience emotional distress due to vision loss. The researchers hypothesize that LVR will lead to measurable functional improvements, which may be further enhanced by ERT, particularly for patients with high levels of vision-related anxiety. Participants will undergo a series of ERT sessions over a 10-week period while being monitored for their visual and emotional progress.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with vision impairment with IRD etiology
* Must have had a clinical exam with an IRD specialist within the three months of assignment to Arm
* Have had a Goldmann visual field that was tested with III-4e isopter within the last year
* Have a disability greater than zero theta in any of the domains of Michigan Retinal Dystrophy Questionnaire (MRDQ)
* Have an indication from the IRD specialist that the ocular condition will not deteriorate over the next 1- year
* 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)

Exclusion Criteria:

* Having other ocular comorbidities including those associated with an IRD such as control of cystoid macular edema (CME)
* Functional needs regarding low vision (i.e. activities of daily living) have been adequately addressed per a study low vision specialist
* Current mental health therapy
* 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)
* 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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: K. Thiran Jayasundera, MD, MS — University of Michigan
• Study coordinator: Jessica Stout
• Email: jrstout@umich.edu
• Phone: 734-763-5590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.