Inherited Retinal DiseasesNCT06651736
Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
A study testing Low Vision Rehabilitation (LVR) and Emotion Regulation Therapy (ERT) in people with Inherited Retinal Diseases, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inherited Retinal Diseases
- What is being tested?
- Low Vision Rehabilitation (LVR) and Emotion Regulation Therapy (ERT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 24 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Jessica Stout, 734-763-5590, jrstout@umich.edu
K. Thiran Jayasundera, MD, MS
About this study
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
- Being tested
- Low Vision Rehabilitation (LVR), Emotion Regulation Therapy (ERT)
- Keywords
- Low Vision Rehabilitation, Emotional Regulation Therapy, Vision-related anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Vision Rehabilitation (LVR)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Low Vision Rehabilitation (LVR); Behavioral: Emotion Regulation Therapy (ERT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 6 months
Secondary outcomes (8)
Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36)
The survey has 36-items in which participants select responses. It measures and produces scores (0-100) for 8 domains (Physical functioning, Role limitations due to physical health, Bodily pain, General health perceptions, Vitality (energy/fatigue), Social functioning, Role limitations due to emotional problems, Mental health (emotional well-being) Scores presented on a 0-100 scale, with scores above 50 generally indicating better-than-average health-related quality of life, and scores below 50 suggesting below-average health.
Measured: 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)
The Psychosocial Impact of Assistive Devices (PIADS) is a 26-item self-reported questionnaire designed to assess the effects of an assistive device on functional independence, well-being and quality of life.
The PIADS Uses a 7-point scale for each item, ranging from -3 to +3. A score of -3 indicates the maximum negative impact, a score of 0 indicates no impact or neutral effect, and a score of +3 indicates the maximum positive impact of devices.
Measured: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire is a 9-item questionnaire designed to assess depression symptoms. Participants answer questions from Not at all (0) -Nearly every day (3). The score ranges from 0 to 27, the higher scores mean more serious depression.
Measured: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS)
The Perceived Stress Scale is a 10-item questionnaire aimed to assess participants perceived stress. Items are scored from never (0) - very often (4). Scores rage from 0-40 with higher scores indicating higher stress.
Measured: 6 months
Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ)
The Daughty Device Compliance Questionnaire (DDCQ) is a 5-item self-reported questionnaire designed to evaluate the adherence to and effectiveness of medical devices in daily use. It assesses factors such as user satisfaction, ease of use, and the impact on health outcomes. Completed for each device participants receive.
Measured: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Generalized Anxiety Disorder (GAD)-7
The 7-item GAD-7 will measure symptoms of anxiety. Items are scored not at all (0) -Nearly every day (3), scores range from 0-21. Higher scores indicate more symptoms of anxiety.
Measured: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Rumination-Reflection Questionnaire (RRQ)
The Rumination-Reflection Questionnaire is a 24-item measure of self-reflection tendencies. Items are scored from strongly disagree (1) - Strongly agree (5). Scores range from 24 to 120; a higher score means a worse outcome.
Measured: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Penn State Worry Questionnaire (PSWQ)
The Penn State Worry Questionnaire is a 16-item self-report scale designed to measure the trait of worry in adults. Items are scored from not at all typical of me (1) - Very typical of me (5). The range of scores are from 16-80 with higher scores indicating higher level of worry.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start13 Jan 2025
- Primary completion24 Nov 2028 (estimated)
- Study completion24 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Retinal DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, K. Thiran Jayasundera, University of Michigan
- Investigators
- K. Thiran Jayasundera, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651736
- Sponsor's protocol ID
- HUM00246479
- Other IDs
- 1R01EY035016-01A1
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
- ClinicalTrials.gov ID
- NCT06651736
- Acronym / sponsor ID
- HUM00246479
- Conditions
- Inherited Retinal Diseases
- Keywords
- Low Vision Rehabilitation, Emotional Regulation Therapy, Vision-related anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 24 Nov 2028 (estimated)
- Study completion
- 24 Nov 2028 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Low Vision Rehabilitation LVR | Active comparator | Behavioral: 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. |
| Arm 2 - ERT (after randomization) and then concurrent with LVR | Experimental | Behavioral: Low Vision Rehabilitation (LVR), Behavioral: Emotion Regulation Therapy (ERT)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. |
| Arm 3- LVR with delayed ERT | Experimental | Behavioral: Low Vision Rehabilitation (LVR), Behavioral: Emotion Regulation Therapy (ERT)Participants with vision-related anxiety (must meet this per protocol by self-reports) randomized to this arm will receive LVR with delayed ERT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 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)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. | Behavioural | Arm 2 - ERT (after randomization) and then concurrent with LVR, Arm 3- LVR with delayed ERT |
Primary outcome
Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)
Time frame: Baseline to 6 month
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).
Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ)
Time frame: Baseline to 6 month
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).
Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQ
Time frame: Baseline, 6 months
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).
Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ
Time frame: Baseline, 6 months
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).
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
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).
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
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).
8 secondary outcomes
Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36)
Time frame: 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)
Time frame: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS)
Time frame: 6 months
Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ)
Time frame: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Generalized Anxiety Disorder (GAD)-7
Time frame: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Rumination-Reflection Questionnaire (RRQ)
Time frame: 6 months
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Penn State Worry Questionnaire (PSWQ)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
K. Thiran Jayasundera, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Vision Rehabilitation (LVR) and Emotion Regulation Therapy (ERT) in people with Inherited Retinal Diseases, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Stout (734-763-5590, jrstout@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.