Monovision for the Treatment of Diplopia

This study has been completed.
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01426672
First received: August 11, 2011
Last updated: August 30, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Strabismic Deviation
Other: Monovision Correction (with the help of glasses or contact lenses)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monovision for Treatment of Diplopia

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine whether monovision correction was useful for the correction of small angle deviations in strabismic patients


Enrollment: 20
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monovision Correctoin
Monovision correction
Other: Monovision Correction (with the help of glasses or contact lenses)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Strabismic Deviation less than 12 Prism Diopters

Exclusion Criteria:

  • Inability to sign informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426672

Locations
Canada, Ontario
Edward Margolin, MD
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
  More Information

No publications provided

Responsible Party: Edward Margolin, MD, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01426672     History of Changes
Other Study ID Numbers: 08-0289-EMargolin
Study First Received: August 11, 2011
Last Updated: August 30, 2011
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Strabismic deviation less than 12 prism diopeters

Additional relevant MeSH terms:
Diplopia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014