NCT01435876

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

4 years

First QC Date

September 13, 2011

Last Update Submit

September 15, 2011

Conditions

Complications

Outcome Measures

Primary Outcomes (1)

  • Postoperative gain of stereopsis

    1month-1 year

Study Arms (4)

Surgical arm

ACTIVE COMPARATOR

UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES

Procedure: Post exercise Surgery

Exercises

ACTIVE COMPARATOR

ORTHOPTICS/MINUS LENS THERAPY

Procedure: Orthoptics

Postoperative Exercises

ACTIVE COMPARATOR

POST SURGICAL ORTHOPTICS/MINUS LENS

Procedure: Postop orthoptics

Surgical

ACTIVE COMPARATOR
Procedure: Post exercises surgery

Interventions

Post exercise SurgeryPROCEDURE

ORTHOPTICS/MINUS LENS THERAPY

Also known as: Accomodative therapy
Surgical arm
OrthopticsPROCEDURE

MINUS LENS THERAPY/ ORTHOPTICS

Also known as: MINUS LENS THERAPY/ORTHOPTICS
Exercises
Postop orthopticsPROCEDURE

ORTHOPTICS/MINUS LENS THERAPY

Also known as: Minus Lens Therapy
Postoperative Exercises
Post exercises surgeryPROCEDURE

UNIOCULAR/BINOCULAR RECESSION/RESECTION

Also known as: Minus Lens Therapy
Surgical

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • No stereopsis
  • Good visual acuity

You may not qualify if:

  • Amblyopia
  • Anisometropia \> 2.5D
  • Vertical deviations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aditya Sudhalkar

Ahmedabad, Gujarat, 380016, India

Location

M & J Institute Of Ophthalmology

Ahmedabad, Gujarat, 380016, India

Location

M & J Institute

Ahmedabad, Gujarat, 380016, India

Location

MeSH Terms

Interventions

Orthoptics

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Aditya A Sudhalkar, M.S.

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Aditya Sudhalkar

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 19, 2011

Study Start

May 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2011

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

IN(3)