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Monovision for the Treatment of Diplopia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426672
First Posted: August 31, 2011
Last Update Posted: August 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mount Sinai Hospital, Canada
  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: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Strabismic Deviation less than 12 Prism Diopters

Exclusion Criteria:

  • Inability to sign informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426672


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

Responsible Party: Edward Margolin, MD, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01426672     History of Changes
Other Study ID Numbers: 08-0289-EMargolin
First Submitted: August 11, 2011
First Posted: August 31, 2011
Last Update Posted: August 31, 2011
Last Verified: January 2011

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