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

September 13, 2011
September 15, 2011
May 2006
May 2010   (final data collection date for primary outcome measure)
Postoperative gain of stereopsis [ Time Frame: 1month-1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01435876 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surgery and Convergence Insufficiency Intermittent Exotropia
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.

Surgery can give better results,

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Complications
  • Procedure: Post exercise Surgery
    ORTHOPTICS/MINUS LENS THERAPY
    Other Name: Accomodative therapy
  • Procedure: Orthoptics
    MINUS LENS THERAPY/ ORTHOPTICS
    Other Name: MINUS LENS THERAPY/ORTHOPTICS
  • Procedure: Postop orthoptics
    ORTHOPTICS/MINUS LENS THERAPY
    Other Name: Minus Lens Therapy
  • Procedure: Post exercises surgery
    UNIOCULAR/BINOCULAR RECESSION/RESECTION
    Other Name: Minus Lens Therapy
  • Active Comparator: Surgical arm
    UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES
    Intervention: Procedure: Post exercise Surgery
  • Active Comparator: Exercises
    ORTHOPTICS/MINUS LENS THERAPY
    Intervention: Procedure: Orthoptics
  • Active Comparator: Postoperative Exercises
    POST SURGICAL ORTHOPTICS/MINUS LENS
    Intervention: Procedure: Postop orthoptics
  • Active Comparator: Surgical
    Intervention: Procedure: Post exercises surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
May 2011
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

  • No stereopsis
  • Good visual acuity

Exclusion Criteria:

  • Amblyopia
  • Anisometropia > 2.5D
  • Vertical deviations
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01435876
12132EH
Yes
Aditya Sudhalkar, Sudhalkar Eye Hospital
Sudhalkar Eye Hospital
Not Provided
Principal Investigator: Aditya A Sudhalkar, M.S. Consultant
Sudhalkar Eye Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP