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Clinical Trials/NCT03431454
NCT03431454UnknownPhase 2

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Shahid Beheshti University of Medical Sciences1 site in 1 country48 target enrollmentStarted: February 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Enrollment
48
Locations
1
Primary Endpoint
symptomatic convergence insufficiency

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
15 Years to 35 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

home-based vision orthoptic therapy (HBVOT) group

Active Comparator

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

Intervention: trained to do the pencil push-ups procedure (Procedure)

office-based vision orthoptic therapy (OBVOT) group

Active Comparator

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

Intervention: using a major amblyoscope twice weekly with additional home orthoptic therapy (Procedure)

augmented office-based vision orthoptic therapy (AOBVOT) group

Active Comparator

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: using three diopter over-minus lenses and a base out prism (Procedure)

Outcomes

Primary Outcomes

symptomatic convergence insufficiency

Time Frame: one month

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zahra Rabbani Khah

Shahid Beheshti University of Medical Sciences

Shahid Beheshti University of Medical Sciences

Study Sites (1)

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