Status:
COMPLETED
Low Vision Intervention Trial II (LOVIT II)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Central Vision Loss From Macular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 read...
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...
Eligibility Criteria
Inclusion
- Primary eye diagnosis (better seeing Eye) macular disease
- Best-corrected visual acuity (better seeing eye) 20/50-20/200
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT00958360
Start Date
August 1 2010
End Date
September 1 2015
Last Update
August 25 2016
Active Locations (7)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
2
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
3
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220
4
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, United States, 45428