Recruiting

Low Vision Rehabilitation

Sponsor:

University of Michigan

Code:

NCT06651736

Conditions

Inherited Retinal Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low Vision Rehabilitation (LVR)

Emotion Regulation Therapy (ERT)

Study Details

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

Study ID

NCT06651736

Start date

Jan 13, 2025

Status verified date

Mar, 2026

Completion date

Nov 24, 2028

Anticipated

Primary completion date

Nov 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 - Low Vision Rehabilitation LVR

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.

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

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.

experimental: Arm 3- LVR with delayed ERT

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

Interventions

Low Vision Rehabilitation (LVR)

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.

Emotion Regulation Therapy (ERT)

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.

Primary outcome measure

  • Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ) [ Time Frame: Baseline to 6 month ]
  • Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ) [ Time Frame: Baseline to 6 month ]
  • Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQ [ Time Frame: Baseline, 6 months ]
  • Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Jessica Stout

734-763-5590jrstout@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Jessica Stout

734-763-5590jrstout@umich.edu

Principal Investigator:

K. Thiran Jayasundera, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-23.