NCT01426672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
Last Updated

August 31, 2011

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

August 11, 2011

Last Update Submit

August 30, 2011

Conditions

Strabismic Deviation

Keywords

Strabismic deviation less than 12 prism diopeters

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Monovision Correctoin

EXPERIMENTAL

Monovision correction

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

Interventions

Monovision Correction (with the help of glasses or contact lenses)OTHER
Monovision Correctoin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Strabismic Deviation less than 12 Prism Diopters

You may not qualify if:

  • Inability to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Margolin, MD

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Interventions

Contact Lenses

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 31, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

August 31, 2011

Record last verified: 2011-01

Locations

CA(1)