Central Vision Loss From Macular DiseasesPhase 2LOVIT IINCT00958360
Low Vision Intervention Trial II (LOVIT II)
A Phase 2 study testing Interdisciplinary Low Vision Service and Basic Low Vision Service in people with Central Vision Loss From Macular Diseases, run by VA Office of Research and Development at 7 sites in United States.
Trial summary
This study will determine if the interdisciplinary team low vision rehabilitation program is more effective than basic low vision care provided by an optometrist working alone in improving visual reading ability in veterans with macular diseases and best corrected visual acuity of 20/50 to 20/200. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Vision Loss From Macular Diseases
- What is being tested?
- Interdisciplinary Low Vision Service and Basic Low Vision Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2010to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Primary eye diagnosis (better seeing Eye) macular disease
- Best-corrected visual acuity (better seeing eye) 20/50-20/200
Who cannot join
- Does not have a telephone
- Does not speak English
- Has received interdisciplinary low vision services
- English literacy less that 5th grade reading level
- Failed TICS
- Unable or unwilling to attend required clinic visits
Show all 14Show fewer
- Severe hearing impairment preventing administration of telephone questionnaires
- Planned cataract extraction in next 4 months
- Visual fields contracted to diameter of 20 degrees in better-seeing eye
- Vitreous hemorrhage or serous hemorrhagic detachment of macula
- CNVM treated with fewer than 3 anti-VEGF injections
- Diabetic macular edema (DME) treated with focal/grid laser within the last two months
- DME treated with intravitreal injections of anti-VEGF or intravitreal triamcinolone acetonide (IVTA) within the last two months
- Cystoid macular edema (CME) treated with topical (non-steroidal anti-inflammatory drugs) NSAIDS, topical steroids or IVTA within the last three months
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: VA Low Vision Intervention Trial (LOVIT) II
This study will determine if the interdisciplinary team low vision rehabilitation program is more effective than basic low vision care provided by an optometrist working alone in improving visual reading ability in veterans with macular diseases and best corrected visual acuity of 20/50 to 20/200.
Read the detailed description
Key Questions: The purpose of our proposed single-masked multicenter randomized controlled trial is to determine if the Interdisciplinary Team approach to low vision service delivery is more effective than the Basic Low Vision Service in improving visual reading ability for 330 veterans with macular diseases and best corrected visual acuity of 20/50-20/200. Effectiveness will be measured with the Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48), a valid and reliable questionnaire that is administered by telephone to capture changes in patients' self-report of their difficulty reading and performing other daily living activities affected by visual impairment before and after rehabilitation. The primary outcome measure is the comparison of changes in patients' visual reading ability on the VA LV VFQ-48 after they receive low vision care from the Interdisciplinary Team or Basic Low Vision Care program. The secondary outcome measures are comparisons of changes in other VA LV VFQ-48 visual ability scores (overall, mobility, visual information processing, visual motor skills). Hypothesis: The improvement in visual reading ability measured with the VA LV VFQ-48 will be larger for patients who received low vision services from the Interdisciplinary Team than for patients who received the Basic Low Vision Service. Specific Aims:(1) Compare the mean changes in patients' visual reading ability (estimated from patients' difficulty ratings of reading items on the VA LV VFQ-48 before and after low vision service delivery) in the Interdisciplinary Team and Basic Low Vision Care Programs.(2) Compare the mean changes in visual ability [patients' difficulty ratings of other items on the VA LV VFQ-48 (mobility, visual information processing, visual motor skills) before and after low vision service delivery] in the Interdisciplinary Team and Basic Low Vision Care programs.(3). Identify the characteristics of patients who benefit from the Interdisciplinary Team and Basic Low Vision Service. (4). Conduct an economic evaluation to compare the costs and cost effectiveness of the Interdisciplinary Team and Basic Low Vision Service.
- Being tested
- Interdisciplinary Low Vision Service, Basic Low Vision Service
- Keywords
- vision, low
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary Low Vision ServiceOther
Also called Interdisciplinary Low Vision Rehabilitation
Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.
Basic Low Vision ServiceOther
Also called Basic Low Vision Rehabilitation
Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. Receives: Other: Interdisciplinary Low Vision Service |
| Arm 2 | Active comparator | Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. Receives: Other: Basic Low Vision Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Measured: changes from baseline to 4 months later
Secondary outcomes (4)
Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
The range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Measured: changes from baseline to 4 months later
Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
The range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Measured: changes from baseline to 4 months later
Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
The range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Measured: changes from baseline to 4 months later
Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
The range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
Measured: changes from baseline to 4 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2010
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Central Vision Loss From Macular DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joan Stelmack, OD MPH, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958360
- Sponsor's protocol ID
- C6958-R
- Acronym
- LOVIT II
- Status last verified
- Jul 2016
- First submitted
- 11 Aug 2009
- Last updated
- 25 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stelmack JA, Tang XC, Reda DJ, Stroupe KT, Rinne S, Massof RW; LOVIT II Study Group. VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. Ophthalmic Physiol Opt. 2012 Nov;32(6):461-71. doi: 10.1111/j.1475-1313.2012.00933.x. Epub 2012 Sep 7.
PubMed 22958237Stelmack JA, Tang C, Wei Y, Rose K, Ballinger R, Whitman O, Chronister C, Sayers S, Massof RW; LOVIT II Study Group. Veterans Affairs Low-vision Intervention Trial II: One-year Follow-up. Optom Vis Sci. 2019 Oct;96(10):718-725. doi: 10.1097/OPX.0000000000001428.
PubMed 31592954Stroupe KT, Stelmack JA, Tang XC, Wei Y, Sayers S, Reda DJ, Kwon E, Massof RW; LOVIT II Study Group. Economic Evaluation of Low-Vision Rehabilitation for Veterans With Macular Diseases in the US Department of Veterans Affairs. JAMA Ophthalmol. 2018 May 1;136(5):524-531. doi: 10.1001/jamaophthalmol.2018.0797.
PubMed 29800250Stelmack JA, Tang XC, Wei Y, Wilcox DT, Morand T, Brahm K, Sayers S, Massof RW; LOVIT II Study Group. Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Feb 1;135(2):96-104. doi: 10.1001/jamaophthalmol.2016.4742.
PubMed 27978569
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VA Low Vision Intervention Trial (LOVIT) II
- ClinicalTrials.gov ID
- NCT00958360
- Acronym / sponsor ID
- LOVIT II / C6958-R
- Keywords
- vision, low
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Aug 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 25 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if the interdisciplinary team low vision rehabilitation program is more effective than basic low vision care provided by an optometrist working alone in improving visual reading ability in veterans with macular diseases and best corrected visual acuity of 20/50 to 20/200.
Detailed description
Key Questions: The purpose of our proposed single-masked multicenter randomized controlled trial is to determine if the Interdisciplinary Team approach to low vision service delivery is more effective than the Basic Low Vision Service in improving visual reading ability for 330 veterans with macular diseases and best corrected visual acuity of 20/50-20/200. Effectiveness will be measured with the Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48), a valid and reliable questionnaire that is administered by telephone to capture changes in patients' self-report of their difficulty reading and performing other daily living activities affected by visual impairment before and after rehabilitation. The primary outcome measure is the comparison of changes in patients' visual reading ability on the VA LV VFQ-48 after they receive low vision care from the Interdisciplinary Team or Basic Low Vision Care program. The secondary outcome measures are comparisons of changes in other VA LV VFQ-48 visual ability scores (overall, mobility, visual information processing, visual motor skills). Hypothesis: The improvement in visual reading ability measured with the VA LV VFQ-48 will be larger for patients who received low vision services from the Interdisciplinary Team than for patients who received the Basic Low Vision Service. Specific Aims:(1) Compare the mean changes in patients' visual reading ability (estimated from patients' difficulty ratings of reading items on the VA LV VFQ-48 before and after low vision service delivery) in the Interdisciplinary Team and Basic Low Vision Care Programs.(2) Compare the mean changes in visual ability [patients' difficulty ratings of other items on the VA LV VFQ-48 (mobility, visual information processing, visual motor skills) before and after low vision service delivery] in the Interdisciplinary Team and Basic Low Vision Care programs.(3). Identify the characteristics of patients who benefit from the Interdisciplinary Team and Basic Low Vision Service. (4). Conduct an economic evaluation to compare the costs and cost effectiveness of the Interdisciplinary Team and Basic Low Vision Service.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Interdisciplinary Low Vision ServiceInterdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. |
| Arm 2 | Active comparator | Other: Basic Low Vision ServiceBasic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary eye diagnosis (better seeing Eye) macular disease
- Best-corrected visual acuity (better seeing eye) 20/50-20/200
Key exclusion criteria (14 listed)
- Does not have a telephone
- Does not speak English
- Has received interdisciplinary low vision services
- English literacy less that 5th grade reading level
- Failed TICS
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 |
|---|---|---|
| Interdisciplinary Low Vision ServiceAlso: Interdisciplinary Low Vision RehabilitationServices are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed. | Other | Arm 1 |
| Basic Low Vision ServiceAlso: Basic Low Vision RehabilitationService is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time. | Other | Arm 2 |
Primary outcome
Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
Time frame: changes from baseline to 4 months later
The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.
4 secondary outcomes
Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
Time frame: changes from baseline to 4 months later
Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
Time frame: changes from baseline to 4 months later
Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
Time frame: changes from baseline to 4 months later
Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
Time frame: changes from baseline to 4 months later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22958237Stelmack JA, Tang XC, Reda DJ, Stroupe KT, Rinne S, Massof RW; LOVIT II Study Group. VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. Ophthalmic Physiol Opt. 2012 Nov;32(6):461-71. doi: 10.1111/j.1475-1313.2012.00933.x. Epub 2012 Sep 7.
- Derived from this study: PubMed 31592954Stelmack JA, Tang C, Wei Y, Rose K, Ballinger R, Whitman O, Chronister C, Sayers S, Massof RW; LOVIT II Study Group. Veterans Affairs Low-vision Intervention Trial II: One-year Follow-up. Optom Vis Sci. 2019 Oct;96(10):718-725. doi: 10.1097/OPX.0000000000001428.
- Derived from this study: PubMed 29800250Stroupe KT, Stelmack JA, Tang XC, Wei Y, Sayers S, Reda DJ, Kwon E, Massof RW; LOVIT II Study Group. Economic Evaluation of Low-Vision Rehabilitation for Veterans With Macular Diseases in the US Department of Veterans Affairs. JAMA Ophthalmol. 2018 May 1;136(5):524-531. doi: 10.1001/jamaophthalmol.2018.0797.
- Derived from this study: PubMed 27978569Stelmack JA, Tang XC, Wei Y, Wilcox DT, Morand T, Brahm K, Sayers S, Massof RW; LOVIT II Study Group. Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Feb 1;135(2):96-104. doi: 10.1001/jamaophthalmol.2016.4742.
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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.
Joan Stelmack, OD MPH principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interdisciplinary Low Vision Service and Basic Low Vision Service in people with Central Vision Loss From Macular Diseases, run by VA Office of Research and Development at 7 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 14 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire (time frame: changes from baseline to 4 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00958360, which also lists 4 linked publications.
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 25 Aug 2016.