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Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Primary Purpose

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
trained to do the pencil push-ups procedure
using a major amblyoscope twice weekly with additional home orthoptic therapy
using three diopter over-minus lenses and a base out prism
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients between 15 and 35 years of age who have symptomatic CI using the Convergence Insufficiency Symptom Survey (CISS) scoring system.
  • best-corrected visual acuity ≥ 20/25
  • exophoria at near at least 4 prism diopters (△) greater than at distance
  • near point of convergence more than 6.0 cm break
  • insufficient positive fusional vergence (PFV) (failing Sheard's criterion or PFV ≤ 15 △ base-out) at near distance.

Exclusion Criteria:

  • amblyopia (VA worse than 20/30 in each eye), presence of manifest strabismus, history of ocular surgery, any systemic disorder, anisometropia of more than 1.5 diopter of myopia or hyperopia or significant refractive error, and nystagmus and usage of medications that may impair accommodation or convergence. ,ocular surface abnormalities or history of ocular allergy or those who had previously been treated for CI

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

home-based vision orthoptic therapy (HBVOT) group

office-based vision orthoptic therapy (OBVOT) group

augmented office-based vision orthoptic therapy (AOBVOT) group

Arm Description

In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week

In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed

For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

Outcomes

Primary Outcome Measures

symptomatic convergence insufficiency
A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)

Secondary Outcome Measures

Full Information

First Posted
December 12, 2017
Last Updated
February 10, 2018
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03431454
Brief Title
Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Official Title
Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2018 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
We compared the effectiveness of three active vision therapy approaches for convergence insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a prospective study and randomly allocated into three groups. In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
home-based vision orthoptic therapy (HBVOT) group
Arm Type
Active Comparator
Arm Description
In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week
Arm Title
office-based vision orthoptic therapy (OBVOT) group
Arm Type
Active Comparator
Arm Description
In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed
Arm Title
augmented office-based vision orthoptic therapy (AOBVOT) group
Arm Type
Active Comparator
Arm Description
For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.
Intervention Type
Procedure
Intervention Name(s)
trained to do the pencil push-ups procedure
Intervention Description
15 minutes per day, five days a week
Intervention Type
Procedure
Intervention Name(s)
using a major amblyoscope twice weekly with additional home orthoptic therapy
Intervention Description
60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed.
Intervention Type
Procedure
Intervention Name(s)
using three diopter over-minus lenses and a base out prism
Intervention Description
For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.
Primary Outcome Measure Information:
Title
symptomatic convergence insufficiency
Description
A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients between 15 and 35 years of age who have symptomatic CI using the Convergence Insufficiency Symptom Survey (CISS) scoring system. best-corrected visual acuity ≥ 20/25 exophoria at near at least 4 prism diopters (△) greater than at distance near point of convergence more than 6.0 cm break insufficient positive fusional vergence (PFV) (failing Sheard's criterion or PFV ≤ 15 △ base-out) at near distance. Exclusion Criteria: amblyopia (VA worse than 20/30 in each eye), presence of manifest strabismus, history of ocular surgery, any systemic disorder, anisometropia of more than 1.5 diopter of myopia or hyperopia or significant refractive error, and nystagmus and usage of medications that may impair accommodation or convergence. ,ocular surface abnormalities or history of ocular allergy or those who had previously been treated for CI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Aletaha, MD
Phone
9822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Aletaha, MD
Phone
9822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33263359
Citation
Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
Results Reference
derived

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Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

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