Age Related Macular Degeneration (ARMD)EFFECTNCT01499628
EFFECT:Eccentric Fixation From Enhanced Clinical Training
A study testing Supervised Reading, EVT at the PRL and EVT at the TRL in people with Age Related Macular Degeneration (ARMD), run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration (ARMD)
- What is being tested?
- Supervised Reading, EVT at the PRL and EVT at the TRL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2011to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of age-related macular degeneration
- Visual acuity 6/12 to 3/60 inclusive in the better eye
- Dense central scotoma confirmed by microperimetry
Who cannot join
- Patients who are not fluent in English or are cognitively impaired
- Patients with serious hearing impairment
- Patients who are hospital inpatients, who are living in nursing homes or are otherwise non-independent
- Ocular co-morbidity (other than mild cataract) in the better eye
- Recent low vision assessment or eccentric viewing training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.
- Conditions
- Age Related Macular Degeneration (ARMD)
- Being tested
- Supervised Reading, EVT at the PRL, EVT at the TRL
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised ReadingBehavioural
Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses
EVT at the PRLBehavioural
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
EVT at the TRLBehavioural
Participant attends once a week for three weeks for a 45 minute appointment of TRL training using the MAIA microperimeter and then further reading using magnifiers and/or spectacles.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Control | No intervention | No extra training will be given. |
| Group 2-Control plus supervised reading | Active comparator | The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks. Receives: Behavioral: Supervised Reading |
| Group 3-EVT at the PRL | Experimental | Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks. Receives: Behavioral: EVT at the PRL |
| Group 4-EVT at the TRL | Experimental | Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks. Receives: Behavioral: EVT at the TRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Massof Activity Inventory - 6 month follow up
Measured: Change from Baseline in Massof Activity Inventory at 6 month follow up
Secondary outcomes (19)
Reading Speed (ReST) - Final Assessment
Measured: Change from Baseline in Reading Speed (ReST) at Final Assessment
Quality of Life (MacDQoL) - Final Assessment
Measured: Change from Baseline in Quality of Life (MacDQoL) at Final Assessment
Quality of Life (MacDQoL) - 6 month follow up
Measured: Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up
Quality of Life (MacDQoL) - 12 month follow up
Measured: Change from Baseline in Quality of Life (MacDQol) at 12 month follow up
Self-reported health status (EQ-5D) - Final Assessment
Measured: Change from Baseline in EQ-5D score at Final Assessment
Self-reported health status (EQ-5D) - 6 month follow up
Measured: Change from Baseline in EQ-5D score at 6 month follow up
Self-reported health status (EQ-5D) - 12 month follow up
Measured: Change from Baseline in EQ-5D score at 12 month follow up
Time Trade Off (TTO) - 6 month follow up
Measured: Change from Baseline in Time Trade Off (TTO) score at 6 month follow up
WHO (Five) Well-Being Index (WBI-5) - Final Assessment
Measured: Change from Baseline in WBI-5 score at Final Assessment
WHO (Five) Well-Being Index (WBI-5) - 6 month follow up
Measured: Change from Baseline in WBI-5 score at 6 month follow up
WHO (Five) Well-Being Index (WBI-5) - 12 month follow up
Measured: Change from Baseline in WBI-5 score at 12 month follow up
Interpersonal Support Evaluation List (ISEL) - Final Assessment
Measured: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment
Interpersonal Support Evaluation List (ISEL) - 6 month follow up
Measured: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 6 month follow up
Interpersonal Support Evaluation List (ISEL) - 12 month follow up
Measured: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 12 month follow up
Acceptance and Self Worth Adjustment Scale (AS-WAS) - Final Assessment
Measured: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at Final Assessment
Acceptance and Self Worth Adjustment Scale (AS-WAS) - 6 month follow up
Measured: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 6 month follow up
Acceptance and Self Worth Adjustment Scale (AS-WAS) - 12 month follow up
Measured: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 12 month follow up
Massof Activity Inventory - Final Assessment
Measured: Change from Baseline in Massof Activity Inventory at Final Assessment
Massof Activity Inventory - 12 month follow up
Measured: Change from Baseline in Massof Activity Inventory at 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study start27 Apr 2011
- Primary completion26 Nov 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular Degeneration (ARMD)Studies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Eye Research Foundation, operating as Fight for Sight
- Responsible party
- Sponsor
- Investigators
- Gary S Rubin, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499628
- Sponsor's protocol ID
- RUBG1008
- Other IDs
- Fight for Sight Ref: 1777/78
- Acronym
- EFFECT
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2011
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
- ClinicalTrials.gov ID
- NCT01499628
- Acronym / sponsor ID
- EFFECT / RUBG1008
- Conditions
- Age Related Macular Degeneration (ARMD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British Eye Research Foundation, operating as Fight for Sight
- Study start
- 27 Apr 2011 (actual)
- Primary completion
- 26 Nov 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 26 Dec 2011 (estimated)
- 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.
Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1-Control | No intervention | –No extra training will be given. |
| Group 2-Control plus supervised reading | Active comparator | Behavioral: Supervised ReadingThe same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks. |
| Group 3-EVT at the PRL | Experimental | Behavioral: EVT at the PRLEccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks. |
| Group 4-EVT at the TRL | Experimental | Behavioral: EVT at the TRLEccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of age-related macular degeneration
- Visual acuity 6/12 to 3/60 inclusive in the better eye
- Dense central scotoma confirmed by microperimetry
Key exclusion criteria (5 listed)
- Patients who are not fluent in English or are cognitively impaired
- Patients with serious hearing impairment
- Patients who are hospital inpatients, who are living in nursing homes or are otherwise non-independent
- Ocular co-morbidity (other than mild cataract) in the better eye
- Recent low vision assessment or eccentric viewing training
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 |
|---|---|---|
| Supervised ReadingParticipant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses | Behavioural | Group 2-Control plus supervised reading |
| EVT at the PRLEccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks. | Behavioural | Group 3-EVT at the PRL |
| EVT at the TRLParticipant attends once a week for three weeks for a 45 minute appointment of TRL training using the MAIA microperimeter and then further reading using magnifiers and/or spectacles. | Behavioural | Group 4-EVT at the TRL |
Primary outcome
Score on the Massof Activity Inventory - 6 month follow up
Time frame: Change from Baseline in Massof Activity Inventory at 6 month follow up
19 secondary outcomes
Reading Speed (ReST) - Final Assessment
Time frame: Change from Baseline in Reading Speed (ReST) at Final Assessment
Quality of Life (MacDQoL) - Final Assessment
Time frame: Change from Baseline in Quality of Life (MacDQoL) at Final Assessment
Quality of Life (MacDQoL) - 6 month follow up
Time frame: Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up
Quality of Life (MacDQoL) - 12 month follow up
Time frame: Change from Baseline in Quality of Life (MacDQol) at 12 month follow up
Self-reported health status (EQ-5D) - Final Assessment
Time frame: Change from Baseline in EQ-5D score at Final Assessment
Self-reported health status (EQ-5D) - 6 month follow up
Time frame: Change from Baseline in EQ-5D score at 6 month follow up
Self-reported health status (EQ-5D) - 12 month follow up
Time frame: Change from Baseline in EQ-5D score at 12 month follow up
Time Trade Off (TTO) - 6 month follow up
Time frame: Change from Baseline in Time Trade Off (TTO) score at 6 month follow up
WHO (Five) Well-Being Index (WBI-5) - Final Assessment
Time frame: Change from Baseline in WBI-5 score at Final Assessment
WHO (Five) Well-Being Index (WBI-5) - 6 month follow up
Time frame: Change from Baseline in WBI-5 score at 6 month follow up
WHO (Five) Well-Being Index (WBI-5) - 12 month follow up
Time frame: Change from Baseline in WBI-5 score at 12 month follow up
Interpersonal Support Evaluation List (ISEL) - Final Assessment
Time frame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at Final Assessment
Interpersonal Support Evaluation List (ISEL) - 6 month follow up
Time frame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 6 month follow up
Interpersonal Support Evaluation List (ISEL) - 12 month follow up
Time frame: Change from Baseline in Interpersonal Support Evaluation List (ISEL) at 12 month follow up
Acceptance and Self Worth Adjustment Scale (AS-WAS) - Final Assessment
Time frame: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at Final Assessment
Acceptance and Self Worth Adjustment Scale (AS-WAS) - 6 month follow up
Time frame: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 6 month follow up
Acceptance and Self Worth Adjustment Scale (AS-WAS) - 12 month follow up
Time frame: Change from Baseline in Acceptance and Self Worth Adjustment Scale (AS-WAS) at 12 month follow up
Massof Activity Inventory - Final Assessment
Time frame: Change from Baseline in Massof Activity Inventory at Final Assessment
Massof Activity Inventory - 12 month follow up
Time frame: Change from Baseline in Massof Activity Inventory at 12 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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. This study is not recruiting at the moment.
Gary S Rubin, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Reading, EVT at the PRL and EVT at the TRL in people with Age Related Macular Degeneration (ARMD), run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 8 Dec 2023. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score on the Massof Activity Inventory - 6 month follow up (time frame: Change from Baseline in Massof Activity Inventory at 6 month follow up). 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 Dec 2023.