Monovision for the Treatment of Diplopia

Strabismic Deviation Clinical Trial

Official title:

Monovision for Treatment of Diplopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426672
• Other study ID #: 08-0289-EMargolin
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2011
• Last updated: August 30, 2011
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Strabismic Deviation less than 12 Prism Diopters

Exclusion Criteria:

• Inability to sign informed consent

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Strabismic Deviation

Intervention

Other:
• Monovision Correction (with the help of glasses or contact lenses)

Locations

Country	Name	City	State
Canada	Edward Margolin, MD	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No