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

NCT06651736 | Recruiting DMC

• 2 other identifiers: HUM002464791R01EY035016-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inherited Retinal Diseases

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)

  The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).

  Baseline to 6 month

• Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ)

  The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).

  Baseline to 6 month

• Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQ

  Comparison between low-distress arm and high-distress arm prior to ERT treatment at month-6. The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).

  Baseline, 6 months

• Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ

  Comparison between low-distress arm and high-distress arm prior to ERT treatment at month-6. The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).

  Baseline, 6 months

• Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by MVAQ

  The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).

  Baseline, 6 months

• Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by the MRDQ

  The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).

  Baseline, 6 months

Secondary Outcomes (8)

• Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36)

  Baseline to 6 month

• Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Psychosocial Impact of Assistive Devices Scale (PIADS)

  6 months

• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9)

  6 months

• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS)

  6 months

• Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ)

  6 months

Study Arms (3)

Arm 1 - Low Vision Rehabilitation LVR

ACTIVE COMPARATOR

Participants (N \~ 60) without vision-related anxiety will be designated to Arm 1 and receive LVR. This group is intended to be a comparison for the higher vision-related anxiety groups. For this reason, these patients may be placed on a waitlist (meaning participants low-vision rehabilitation may be delayed), until the study team can match with someone in one of the other groups.

Behavioral: Low Vision Rehabilitation (LVR)

Arm 2 - ERT (after randomization) and then concurrent with LVR

EXPERIMENTAL

Participants with vision-related anxiety (must meet this per protocol by self-reports) randomized to this arm will receive immediate ERT. The LVR therapy will start approximately during 4-6 sessions of ERT.

Behavioral: Low Vision Rehabilitation (LVR); Behavioral: Emotion Regulation Therapy (ERT)

Arm 3- LVR with delayed ERT

EXPERIMENTAL

Participants with vision-related anxiety (must meet this per protocol by self-reports) randomized to this arm will receive LVR with delayed ERT.

Behavioral: Low Vision Rehabilitation (LVR); Behavioral: Emotion Regulation Therapy (ERT)

Interventions

Low Vision Rehabilitation (LVR) BEHAVIORAL

The initial session will be with an LVR specialist that will recommend vision-enhancing devices and techniques to improve participant's vision and mobility functionality depending on needs. The devices will be given at no cost and include, but are not limited to: magnifiers that participants can hold or wear, glasses attachments that help filter out light to see better, or items that help with glare or seeing color. This session will be followed by at least one session with an occupational therapist, that will train participants to use the devices (take home and use) and recommend/teach ways to achieve functional goals. Most participants will be asked to attend 2-4 visits, but additional visits may be needed depending on needs and progress toward functional goals. Additional visits if orientation and mobility training is also recommended. Participants will be asked to share experiences approximately 1-week after all visits.

Arm 1 - Low Vision Rehabilitation LVR; Arm 2 - ERT (after randomization) and then concurrent with LVR; Arm 3- LVR with delayed ERT

Emotion Regulation Therapy (ERT) BEHAVIORAL

There will be ten 1-hour weekly sessions of specialized psychotherapy with an ERT-trained therapist. These are typically done virtually but may be able to provide in-person sessions to those where this is needed. At the beginning of each session, the therapist will give participant's several questionnaires to learn about participant's experience with ERT. Questionnaires will also be completed after all sessions are completed.

Arm 2 - ERT (after randomization) and then concurrent with LVR; Arm 3- LVR with delayed ERT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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)

You may not qualify 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 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

Sponsors & Collaborators

• University of Michigan: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

RECRUITING

Study Officials

• K. Thiran Jayasundera, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Stout

CONTACT

734-763-5590; jrstout@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The 6 and 12-month post-LVR assessments will be administered by a study team member that is masked to Arm assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology and Visual Sciences and Associate Chair

Model Details: Participants with IRD will be recruited and will be allocated into one of three study arms, depending on self-reported anxiety. Participants (N \~ 60) without vision-related anxiety will be designated to Arm 1 and receive LVR. Participants (N \~ 120) with vision-related anxiety will be randomly assigned to either Arm 2 or 3, in which participants will receive LVR with adjunctive ERT.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): November 24, 2028
• Study Completion (Estimated): November 24, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)