Low Vision, One Eye, Unspecified EyeNCT03166072
Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
A study testing Meditation and Health Enhancement Program in people with Low Vision, One Eye, Unspecified Eye and Low Vision Blindness, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation and a Health Enhancement Program, for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Low Vision, One Eye, Unspecified Eye, Low Vision Blindness
- What is being tested?
- Meditation and Health Enhancement Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2026to 20 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with irreversible age-related vision loss (IARVL) and have ongoing significant disability and/or their caregivers who agree to consent.
- IARVL patients between age 60 to 85 years or caregivers between 18 to 85 years.
- Deemed competent to provide individual consent to participate.
- Speak and understand English without requirement for interpretation or assistance.
- Have no significant self-reported or physician diagnosed mental health disorder other than depressive and/or anxiety symptoms.
- Have either a minimum of CES-D 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety Scale (HADS-A) 7-item sub-scale.
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- Have sufficient hearing to be able to follow verbal instructions
- Ability to sit independently without physical discomfort for 30 minutes.
- Willing and able to attend, via Microsoft TEAMS software, the four initial training sessions of MEDITATION or HEP and at least 6 follow-up sessions.
- Willing to dedicate 33 minutes per day to their assigned home practice.
Who cannot join
- Inability to provide informed consent.
- Dementia as defined by MoCA < 21.
- Have significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
- Have severe depression CES-D ≥ 24.
- Participating in other similar studies.
- Have a lifetime diagnosis of self-reported other mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
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- Self-reported substance abuse or dependence within the past 3 months.
- Have an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
- Have a terminal medical diagnosis with prognosis of less than 12 months.
- Having any planned changes to mood-altering medications at the time of enrollment for the next 12 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation and a Health Enhancement Program, for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers.
Read the detailed description
Using a mixed-method design, a pilot randomized controlled trial (RCT) study, investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation to Remove Stress and Create Proper System in Mind (MEDITATION) and a Health Enhancement Program (HEP) for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers. MEDITATION is a standardized, manualized therapy where participants will be guided by an instructor on meditation techniques, followed by weekly reinforcement sessions. HEP is a similarly structured intervention that controls for several factors experienced in the MEDITATION group, such as group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation.
- Being tested
- Meditation, Health Enhancement Program
- Keywords
- Irreversible age-related vision loss, Randomized controlled trial, Meditation, Pilot study, Quality of life
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
This therapy will be delivered using the hospital approved Microsoft TEAMS platform by trained, certified non-clinician teachers. 25 irreversible age-related vision loss patients and their 25 caregivers in the MEDITATION arm will be trained for 2 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will learn how to respond to experiences that arise in meditation, will discuss what enhances or detracts from effective meditation, and review methods for meditating at home. Weekly reinforcement sessions will include 33 minutes of guided meditation practice, and then focus on participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Each of these follow-up sessions will include a 33-minute guided meditation session. Participants will also be encouraged to practice daily at home for 33 minutes per session.
Health Enhancement ProgramOther
HEP was designed and used as a manualized active control in meditation-based intervention trials. We have tailored HEP to be structurally equivalent to MEDITATION intervention, with similar-sized groups, meeting for 2 days for 2 hours, and then one 60-75-minute follow up session weekly for the subsequent 11 follow ups. Participants allocated to HEP will be completing the same amount of home practice as MEDITATION, and will be asked to complete weekly practice logs. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation. In HEP, which is provided according to specific guidelines for administration, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Active comparator | Participants randomized to this arm will undergo the MEDITATION intervention, with weekly training and reinforcement sessions. Receives: Other: Meditation |
| Treatment as Usual | No intervention | Participants randomized to this arm will continue to undergo the usual standard of care. The usual standard of care for IARVL patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision. |
| Health Enhancement Program (HEP) | Other | Participants randomized to this arm will undergo the Health Enhancement Program (HEP) intervention, with weekly sessions identical in structure to those of the MEDITATION arm. Receives: Other: Health Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants screened
Number of participants screened
Measured: Through study completion, an average of 1 year
Participants enrolled
Proportion of patients and caregivers who enrol in the study after screening
Measured: Through study completion, an average of 1 year
Retention rate
Rate of participation retention in the study
Measured: Up to 12 weeks.
Adherence rate
Rate of adherence to study protocol
Measured: Up to 12 weeks
Assessment rating and duration
Proportion of planned ratings that are completed and duration of assessment visits
Measured: Up to 12 weeks
Intervention cost
Intervention cost per case
Measured: Up to 12 weeks
Data quality
Completeness and quality of final data for analysis
Measured: Up to 12 weeks
Secondary outcomes (8)
Change in health-related quality of life (HRQOL)
Improvement in HRQOL score as measured by the Short Form 12 Health Survey (SF-12) up to 12 weeks.
Measured: Up to 12 weeks
Number of participants approached
Number of potential participants (IARVL patients and their caregivers) approached per month
Measured: Through study completion, an average of 1 year
Change in vision-related quality of life (VRQOL)
Improvement in VRQOL score as measured by the Visual Function 14-item questionnaire (VF-14) up to 12 weeks.
Measured: Up to 12 weeks
Change in depression score
Reduction in depressive symptoms as measured by the Center for Epidemiological Studies Depression questionnaire (CES-D) scores up to 12 weeks.
Measured: Up to 12 weeks
Change in anxiety score
Reduction in anxiety symptoms as measured by the Hospital Anxiety Scale questionnaire (HADS-A) scores up to 12 weeks.
Measured: Up to 12 weeks
Change in sleep quality
Enhanced sleep quality as measured by reduction in Pittsburg Sleep Quality Index questionnaire (PSQI) scores (≤ 5) up to 12 weeks.
Measured: Up to 12 weeks
Change in community integration
Enhanced community integration as measured by an increase in Community Integration Questionnaire (CIQ) scores up to 12 weeks.
Measured: Up to 12 weeks
Change in caregiver burden
Reduced caregiver burden as measured by reduction in Zarit Burden Interview (ZBI) scores up to 12 weeks.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start20 Apr 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Vision, One Eye, Unspecified EyeStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monali Malvankar, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Monali Malvankar, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166072
- Sponsor's protocol ID
- 111334
- Status last verified
- Jan 2026
- First submitted
- 23 May 2017
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers since the current research team has the necessary expertise to conduct data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT03166072
- Acronym / sponsor ID
- 111334
- Keywords
- Irreversible age-related vision loss, Randomized controlled trial, Meditation, Pilot study, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 24 May 2017 (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.
Investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation and a Health Enhancement Program, for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers.
Detailed description
Using a mixed-method design, a pilot randomized controlled trial (RCT) study, investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation to Remove Stress and Create Proper System in Mind (MEDITATION) and a Health Enhancement Program (HEP) for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers. MEDITATION is a standardized, manualized therapy where participants will be guided by an instructor on meditation techniques, followed by weekly reinforcement sessions. HEP is a similarly structured intervention that controls for several factors experienced in the MEDITATION group, such as group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meditation | Active comparator | Other: MeditationParticipants randomized to this arm will undergo the MEDITATION intervention, with weekly training and reinforcement sessions. |
| Treatment as Usual | No intervention | –Participants randomized to this arm will continue to undergo the usual standard of care. The usual standard of care for IARVL patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision. |
| Health Enhancement Program (HEP) | Other | Other: Health Enhancement ProgramParticipants randomized to this arm will undergo the Health Enhancement Program (HEP) intervention, with weekly sessions identical in structure to those of the MEDITATION arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with irreversible age-related vision loss (IARVL) and have ongoing significant disability and/or their caregivers who agree to consent.
- IARVL patients between age 60 to 85 years or caregivers between 18 to 85 years.
- Deemed competent to provide individual consent to participate.
- Speak and understand English without requirement for interpretation or assistance.
- Have no significant self-reported or physician diagnosed mental health disorder other than depressive and/or anxiety symptoms.
Key exclusion criteria (10 listed)
- Inability to provide informed consent.
- Dementia as defined by MoCA < 21.
- Have significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
- Have severe depression CES-D ≥ 24.
- Participating in other similar studies.
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 |
|---|---|---|
| MeditationThis therapy will be delivered using the hospital approved Microsoft TEAMS platform by trained, certified non-clinician teachers. 25 irreversible age-related vision loss patients and their 25 caregivers in the MEDITATION arm will be trained for 2 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will learn how to respond to experiences that arise in meditation, will discuss what enhances or detracts from effective meditation, and review methods for meditating at home. Weekly reinforcement sessions will include 33 minutes of guided meditation practice, and then focus on participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Each of these follow-up sessions will include a 33-minute guided meditation session. Participants will also be encouraged to practice daily at home for 33 minutes per session. | Other | Meditation |
| Health Enhancement ProgramHEP was designed and used as a manualized active control in meditation-based intervention trials. We have tailored HEP to be structurally equivalent to MEDITATION intervention, with similar-sized groups, meeting for 2 days for 2 hours, and then one 60-75-minute follow up session weekly for the subsequent 11 follow ups. Participants allocated to HEP will be completing the same amount of home practice as MEDITATION, and will be asked to complete weekly practice logs. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation. In HEP, which is provided according to specific guidelines for administration, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes. | Other | Health Enhancement Program (HEP) |
Primary outcome
Participants screened
Time frame: Through study completion, an average of 1 year
Number of participants screened
Participants enrolled
Time frame: Through study completion, an average of 1 year
Proportion of patients and caregivers who enrol in the study after screening
Retention rate
Time frame: Up to 12 weeks.
Rate of participation retention in the study
Adherence rate
Time frame: Up to 12 weeks
Rate of adherence to study protocol
Assessment rating and duration
Time frame: Up to 12 weeks
Proportion of planned ratings that are completed and duration of assessment visits
Intervention cost
Time frame: Up to 12 weeks
Intervention cost per case
Data quality
Time frame: Up to 12 weeks
Completeness and quality of final data for analysis
8 secondary outcomes
Change in health-related quality of life (HRQOL)
Time frame: Up to 12 weeks
Number of participants approached
Time frame: Through study completion, an average of 1 year
Change in vision-related quality of life (VRQOL)
Time frame: Up to 12 weeks
Change in depression score
Time frame: Up to 12 weeks
Change in anxiety score
Time frame: Up to 12 weeks
Change in sleep quality
Time frame: Up to 12 weeks
Change in community integration
Time frame: Up to 12 weeks
Change in caregiver burden
Time frame: Up to 12 weeks
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 3 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers since the current research team has the necessary expertise to conduct data analysis.
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.
Monali Malvankar principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation and Health Enhancement Program in people with Low Vision, One Eye, Unspecified Eye and Low Vision Blindness, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Feb 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 Canada. 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 Monali Malvankar, PhD (5196858500 ext. 61288, monali.malvankar@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants screened (time frame: Through study completion, an average of 1 year). The study lists 7 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 3 Feb 2026.