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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

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

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

NCT ID

NCT03431454

First Posted

December 12, 2017

Last Updated

February 10, 2018

Sponsor

Shahid Beheshti University of Medical Sciences

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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

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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