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Surgery and Convergence Insufficiency Intermittent Exotropia

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.
ClinicalTrials.gov Identifier: NCT01435876
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : September 19, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.

Condition or disease Intervention/treatment
Complications Procedure: Post exercise Surgery Procedure: Orthoptics Procedure: Postop orthoptics Procedure: Post exercises surgery

Detailed Description:
Surgery can give better results,

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial
Study Start Date : May 2006
Primary Completion Date : May 2010
Study Completion Date : May 2011


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Postoperative gain of stereopsis [ Time Frame: 1month-1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

  • No stereopsis
  • Good visual acuity

Exclusion Criteria:

  • Amblyopia
  • Anisometropia > 2.5D
  • Vertical deviations
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): NCT01435876


Locations
India
Aditya Sudhalkar
Ahmedabad, Gujarat, India, 380016
M & J Institute Of Ophthalmology
Ahmedabad, Gujarat, India, 380016
M & J Institute
Ahmedabad, Gujarat, India, 380016
Sponsors and Collaborators
Sudhalkar Eye Hospital
Investigators
Principal Investigator: Aditya A Sudhalkar, M.S. Consultant
More Information

Responsible Party: Aditya Sudhalkar, Dr. Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier: NCT01435876     History of Changes
Other Study ID Numbers: 12132EH
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Exotropia
Ocular Motility Disorders
Strabismus
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Central Nervous System Diseases