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NCT01435876 Clinical Trial

Surgery and Convergence Insufficiency Intermittent Exotropia

Complications Clinical Trial

Official title:
Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01435876
Other study ID # 12132EH
Secondary ID
Status Completed
Phase N/A
First received September 13, 2011
Last updated September 15, 2011
Start date May 2006
Est. completion date May 2011

Study information
Verified date September 2011
Source Sudhalkar Eye Hospital
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Description:

Surgery can give better results,

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date May 2011
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

- No stereopsis

- Good visual acuity

Exclusion Criteria:

- Amblyopia

- Anisometropia > 2.5D

- Vertical deviations

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Post exercise Surgery
ORTHOPTICS/MINUS LENS THERAPY
• Orthoptics
MINUS LENS THERAPY/ ORTHOPTICS
• Postop orthoptics
ORTHOPTICS/MINUS LENS THERAPY
• Post exercises surgery
UNIOCULAR/BINOCULAR RECESSION/RESECTION

Locations
Country Name City State
India Aditya Sudhalkar Ahmedabad Gujarat
India M & J Institute Ahmedabad Gujarat
India M & J Institute Of Ophthalmology Ahmedabad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Sudhalkar Eye Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative gain of stereopsis 1month-1 year Yes
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