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Surgery and Convergence Insufficiency Intermittent Exotropia

Primary Purpose

Complications

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Post exercise Surgery
Orthoptics
Postop orthoptics
Post exercises surgery
Sponsored by
Sudhalkar Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

  • No stereopsis
  • Good visual acuity

Exclusion Criteria:

  • Amblyopia
  • Anisometropia > 2.5D
  • Vertical deviations

Sites / Locations

  • Aditya Sudhalkar
  • M & J Institute Of Ophthalmology
  • M & J Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Surgical arm

Exercises

Postoperative Exercises

Surgical

Arm Description

UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES

ORTHOPTICS/MINUS LENS THERAPY

POST SURGICAL ORTHOPTICS/MINUS LENS

Outcomes

Primary Outcome Measures

Postoperative gain of stereopsis

Secondary Outcome Measures

Full Information

First Posted
September 13, 2011
Last Updated
September 15, 2011
Sponsor
Sudhalkar Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01435876
Brief Title
Surgery and Convergence Insufficiency Intermittent Exotropia
Official Title
Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sudhalkar Eye Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.
Detailed Description
Surgery can give better results,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical arm
Arm Type
Active Comparator
Arm Description
UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES
Arm Title
Exercises
Arm Type
Active Comparator
Arm Description
ORTHOPTICS/MINUS LENS THERAPY
Arm Title
Postoperative Exercises
Arm Type
Active Comparator
Arm Description
POST SURGICAL ORTHOPTICS/MINUS LENS
Arm Title
Surgical
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Post exercise Surgery
Other Intervention Name(s)
Accomodative therapy
Intervention Description
ORTHOPTICS/MINUS LENS THERAPY
Intervention Type
Procedure
Intervention Name(s)
Orthoptics
Other Intervention Name(s)
MINUS LENS THERAPY/ORTHOPTICS
Intervention Description
MINUS LENS THERAPY/ ORTHOPTICS
Intervention Type
Procedure
Intervention Name(s)
Postop orthoptics
Other Intervention Name(s)
Minus Lens Therapy
Intervention Description
ORTHOPTICS/MINUS LENS THERAPY
Intervention Type
Procedure
Intervention Name(s)
Post exercises surgery
Other Intervention Name(s)
Minus Lens Therapy
Intervention Description
UNIOCULAR/BINOCULAR RECESSION/RESECTION
Primary Outcome Measure Information:
Title
Postoperative gain of stereopsis
Time Frame
1month-1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia No stereopsis Good visual acuity Exclusion Criteria: Amblyopia Anisometropia > 2.5D Vertical deviations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditya A Sudhalkar, M.S.
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aditya Sudhalkar
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
M & J Institute Of Ophthalmology
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
M & J Institute
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India

12. IPD Sharing Statement

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Surgery and Convergence Insufficiency Intermittent Exotropia

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