Back to resultsMonovision for the Treatment of Diplopia
Primary Purpose
Strabismic Deviation
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Monovision Correction (with the help of glasses or contact lenses)
Sponsored by
About this trial
This is an interventional treatment trial for Strabismic Deviation focused on measuring Strabismic deviation less than 12 prism diopeters
Eligibility Criteria
Inclusion Criteria:
- Strabismic Deviation less than 12 Prism Diopters
Exclusion Criteria:
- Inability to sign informed consent
Sites / Locations
- Edward Margolin, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monovision Correctoin
Arm Description
Monovision correction
Outcomes
Primary Outcome Measures
Patients satisfaction with monovision was measured by standardized diplopia questionnaire and results reported in statistical terms on multiple measures tested on the questionnaire.
To determine whether monovision correction was useful for the correction of small angle deviations in strabismic patients
Secondary Outcome Measures
Full Information
NCT ID
NCT01426672
First Posted
August 11, 2011
Last Updated
August 30, 2011
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01426672
Brief Title
Monovision for the Treatment of Diplopia
Official Title
Monovision for Treatment of Diplopia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PURPOSE:
The purpose of this study is to quantitatively assess the efficacy of monovision correction in the treatment of acquired small angle binocular diplopia in adult patients.
METHOD:
Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial. All had stable deviations of 10 prism diopters or less for over three months. Each received monovision spectacles and/ or contact lenses with distance correction in the dominant eye. Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were used to quantify the efficacy of monovision correction for diplopia by measuring the functional impact on vision-specific quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismic Deviation
Keywords
Strabismic deviation less than 12 prism diopeters
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monovision Correctoin
Arm Type
Experimental
Arm Description
Monovision correction
Intervention Type
Other
Intervention Name(s)
Monovision Correction (with the help of glasses or contact lenses)
Primary Outcome Measure Information:
Title
Patients satisfaction with monovision was measured by standardized diplopia questionnaire and results reported in statistical terms on multiple measures tested on the questionnaire.
Description
To determine whether monovision correction was useful for the correction of small angle deviations in strabismic patients
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Strabismic Deviation less than 12 Prism Diopters
Exclusion Criteria:
Inability to sign informed consent
Facility Information:
Facility Name
Edward Margolin, MD
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Monovision for the Treatment of Diplopia
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