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Surgery and Convergence Insufficiency Intermittent Exotropia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier:
NCT01435876
First received: September 13, 2011
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention
Complications
 Procedure: Post exercise Surgery
Procedure: Orthoptics
Procedure: Postop orthoptics
Procedure: Post exercises surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sudhalkar Eye Hospital:

Primary Outcome Measures:
  • Postoperative gain of stereopsis [ Time Frame: 1month-1 year ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Surgery can give better results,

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435876

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

No publications provided

Responsible Party: Aditya Sudhalkar, Dr. Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier: NCT01435876     History of Changes
Other Study ID Numbers: 12132EH
Study First Received: September 13, 2011
Last Updated: September 15, 2011
Health Authority: India: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013