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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435876

Locations
India
Aditya Sudhalkar
Ahmedabad, Gujarat, India, 380016
M & J Institute
Ahmedabad, Gujarat, India, 380016
M & J Institute Of Ophthalmology
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:
Ocular Motility Disorders
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 23, 2014