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New treatment option for Inherited Retinal Diseases
Official title Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
ClinicalTrials.gov ID: NCT06651736
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Inability to complete study task requirements
See the full eligibility 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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.