Phase 2
N=323
Low Vision Intervention Trial II (LOVIT II)
Central Vision Loss From Macular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00958360 ↗Enrolled (actual)
323
Serious AEs
17.3%
Results posted
Aug 2016
Primary outcome: Primary: Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire — 1.29; 0.95 logits — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interdisciplinary Low Vision Service (Other); Basic Low Vision Service (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire |
1.29; 0.95 | 0.05 |
| SECONDARY Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire |
0.31; 0.12 | 0.13 |
| SECONDARY Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire |
0.67; 0.40 | 0.05 |
| SECONDARY Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire |
0.77; 0.40 | 0.013 sig |
| SECONDARY Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire |
0.70; 0.43 | 0.013 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Primary eye diagnosis (better seeing Eye) macular disease
- Best-corrected visual acuity (better seeing eye) 20/50-20/200
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00958360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.