Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency Clinical Trial

Official title:

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431454
• Other study ID #: 92149
• Status: Recruiting
• Phase: Phase 2
• First received: December 12, 2017
• Last updated: February 10, 2018
• Start date: February 2018
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Maryam Aletaha, MD
• Phone: 9822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
• Ocular Motility Disorders

Intervention

Procedure:
• trained to do the pencil push-ups procedure
15 minutes per day, five days a week
• using a major amblyoscope twice weekly with additional home orthoptic therapy
60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed.
• using three diopter over-minus lenses and a base out prism
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic convergence insufficiency	A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)	one month