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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014