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Can talk therapy boost the benefits of low vision aids for people with inherited eye diseases?

NCT ID NCT06651736

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding emotional regulation therapy (ERT) to standard low vision rehabilitation (LVR) helps people with inherited retinal diseases who feel anxious or distressed about their vision. About 180 participants will receive LVR, which includes free vision-enhancing devices and training. Those with high distress will also get ERT. The goal is to see if the combination improves daily function and reduces anxiety more than LVR alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low Vision Rehabilitation (LVR) and Emotional Regulation Therapy (ERT)
What this could lead to
If it works, this could point toward a better way to help people with inherited retinal diseases manage daily tasks and reduce anxiety related to vision loss.
What could go wrong
This is an early-stage study with only 180 participants, so results may not apply to everyone. The main outcomes are based on questionnaires, not direct measures of vision improvement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

inherited retinal dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inherited retinal diseases

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

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