Visual LossNCT07715695
Evaluation of a Scalable Educational Intervention for Adjustment and Coping to Vision Loss
A study testing audiovisual educational intervention in people with Visual Loss, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The goal of this interventional study is to learn if an educational intervention improves awareness in people experiencing visual loss. The main question it aim to answer is: Will participants have an improved awareness of shared experiences regarding themes such as grief and isolation? Participants will be asked to… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Visual Loss
- What is being tested?
- audiovisual educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2026to 30 Jun 2027
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have capacity to provide informed consent
- have had a visit within a low-vision rehabilitation clinic
Who cannot join
- are unable to engage with the audiovisual educational intervention
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Brigham and Women's Hospital, Mass General Brigham
Boston, Massachusetts, 02115
New England College of Optometry
Boston, Massachusetts, 02115
About this study
The goal of this interventional study is to learn if an educational intervention improves awareness in people experiencing visual loss. The main question it aim to answer is:
- Will participants have an improved awareness of shared experiences regarding themes such as grief and isolation?
Participants will be asked to answer questions, engage with an audiovisual educational intervention, and then answer additional questions.
- Conditions
- Visual Loss
- Being tested
- audiovisual educational intervention
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audiovisual educational interventionOther
A brief audiovisual educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Arm | Experimental | Not described Receives: Other: audiovisual educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Educational Awareness of Shared Themes as Measured by Likert-scale Questions
Higher values (or increases relative to baseline) correspond to better outcomes, with each question having a minimum value of 1 and a maximum value of 5.
Measured: From baseline to completion of post-intervention questions (e.g., within 1 week).
Secondary outcomes (2)
Change from Baseline in Screening Measures of Depression and Anxiety as Measured by the Patient Health Questionnaire 4 (PHQ-4)
Lower values (or decreases relative to baseline) correspond to better outcomes, with each question having a minimum value of 0 and a maximum value of 3.
Measured: From baseline to completion of post-intervention questions (e.g., within 1 week).
Change from Baseline of Vision-Related Wellbeing as Measured by the Visual Function Questionnaire 25 (VFQ-25) Socioemotional Wellbeing Subscale
Measured: From baseline to completion of post-intervention questions (e.g., within 1 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start21 Jul 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual LossStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- New England College of Optometry, Hadley Foundation, Inc.
- Responsible party
- Principal investigator, Ali S Raza, MD, PhD, Brigham and Women's Hospital
- Investigators
- Ali S Raza, MD, PhD, Principal investigator, Brigham and Women's Hospital, Mass General Brigham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715695
- Sponsor's protocol ID
- 2026P001151
- Other IDs
- HADLEY-RFA-2026-01
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Scalable Educational Intervention for Adjustment and Coping to Vision Loss
- ClinicalTrials.gov ID
- NCT07715695
- Acronym / sponsor ID
- 2026P001151
- Conditions
- Visual Loss
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- New England College of Optometry, Hadley Foundation, Inc.
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jul 2026 (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 goal of this interventional study is to learn if an educational intervention improves awareness in people experiencing visual loss. The main question it aim to answer is:
- Will participants have an improved awareness of shared experiences regarding themes such as grief and isolation?
Participants will be asked to answer questions, engage with an audiovisual educational intervention, and then answer additional questions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Arm | Experimental | Other: audiovisual educational intervention |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have capacity to provide informed consent
- have had a visit within a low-vision rehabilitation clinic
Key exclusion criteria (1 listed)
- are unable to engage with the audiovisual educational intervention
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 |
|---|---|---|
| audiovisual educational interventionA brief audiovisual educational intervention. | Other | Educational Intervention Arm |
Primary outcome
Change from Baseline in Educational Awareness of Shared Themes as Measured by Likert-scale Questions
Time frame: From baseline to completion of post-intervention questions (e.g., within 1 week).
Higher values (or increases relative to baseline) correspond to better outcomes, with each question having a minimum value of 1 and a maximum value of 5.
2 secondary outcomes
Change from Baseline in Screening Measures of Depression and Anxiety as Measured by the Patient Health Questionnaire 4 (PHQ-4)
Time frame: From baseline to completion of post-intervention questions (e.g., within 1 week).
Change from Baseline of Vision-Related Wellbeing as Measured by the Visual Function Questionnaire 25 (VFQ-25) Socioemotional Wellbeing Subscale
Time frame: From baseline to completion of post-intervention questions (e.g., within 1 week).
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 8 Oct 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.
Ali S Raza, MD, PhD principal investigator
Brigham and Women's Hospital, Mass General Brigham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing audiovisual educational intervention in people with Visual Loss, run by Brigham and Women's Hospital at 2 sites 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Educational Awareness of Shared Themes as Measured by Likert-scale Questions (time frame: From baseline to completion of post-intervention questions (e.g., within 1 week).). 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 8 Oct 2026.