Surgery and Convergence Insufficiency Intermittent Exotropia

September 15, 2011 updated by: Aditya Sudhalkar, Sudhalkar Eye Hospital

Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial

This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgery can give better results,

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • Aditya Sudhalkar
      • Ahmedabad, Gujarat, India, 380016
        • M & J Institute Of Ophthalmology
      • Ahmedabad, Gujarat, India, 380016
        • M & J Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

  • No stereopsis
  • Good visual acuity

Exclusion Criteria:

  • Amblyopia
  • Anisometropia > 2.5D
  • Vertical deviations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgical
Procedure: Post exercises surgery
UNIOCULAR/BINOCULAR RECESSION/RESECTION
Other Names:
  • Minus Lens Therapy
Active Comparator: Surgical arm
UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES
Procedure: Post exercise Surgery
ORTHOPTICS/MINUS LENS THERAPY
Other Names:
  • Accomodative therapy
Active Comparator: Exercises
ORTHOPTICS/MINUS LENS THERAPY
Procedure: Orthoptics
MINUS LENS THERAPY/ ORTHOPTICS
Other Names:
  • MINUS LENS THERAPY/ORTHOPTICS
Active Comparator: Postoperative Exercises
POST SURGICAL ORTHOPTICS/MINUS LENS
Procedure: Postop orthoptics
ORTHOPTICS/MINUS LENS THERAPY
Other Names:
  • Minus Lens Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative gain of stereopsis
Time Frame: 1month-1 year
1month-1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sudhalkar Eye Hospital

Investigators

  • Principal Investigator: Aditya A Sudhalkar, M.S., Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 19, 2011

Study Record Updates

Last Update Posted (Estimate)

September 19, 2011

Last Update Submitted That Met QC Criteria

September 15, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12132EH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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