Combining vision rehabilitation with emotional therapy for patients with inherited retinal diseases
Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
This study is testing if combining vision rehabilitation with emotional therapy can help people with inherited retinal diseases feel better emotionally and improve their vision skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06651736 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with inherited retinal diseases who experience emotional distress related to their vision impairment.
Not a fit: Patients with other ocular comorbidities or those whose functional needs have already been adequately addressed may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and emotional well-being of patients with inherited retinal diseases.
How similar studies have performed: While this specific combination of therapies is novel, similar approaches in addressing emotional distress in patients with chronic conditions have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.