Monovision for the Treatment of Diplopia | NCT01426672

Studies
Monovision for the Treatment of Diplopia

NCT01426672

Sponsor

Mount Sinai Hospital, Canada

Status

Completed

Last Update Posted

Aug 31, 2011Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Strabismic Deviation

Interventions

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

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Aug 11, 2011

First Submission Date that Met QC Criteria

Aug 30, 2011

First Posted Date

Aug 31, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2011

Last Update Posted Date

Aug 31, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monovision Correctoin	Experimental	Monovision correction	Other: Monovision Correction (with the help of glasses or contact lenses)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monovision Correction (with the help of glasses or contact lenses)	Other		Monovision Correctoin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Strabismic Deviation less than 12 Prism Diopters

Exclusion Criteria:

Inability to sign informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edward Margolin, MD		Toronto	Ontario	M5G 1X5	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D003261	Contact Lenses

Ancestor Terms

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided