Characteristics of the Vergence Responses of Binocularly Normal Subjects After a Vision Therapy Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-02

Study Completion Date

2022-03-29

Brief Summary

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A vision therapy protocol for vergence ability is mentioned. The purpose of this study is to evaluate objectively the change in the vergence responses of binocular and accommodative normal subjects after performing a classic vision therapy protocol. This study is an interventional, cross-over, and randomized study.

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Detailed Description

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After the first evaluation, subjects will be classified in the Experimental Group (EG) or Control Group (CG) randomly. There will be 18 subjects in each group. A classic vision therapy protocol for fusional vergence will be performed in the EG and the CG will be doing a placebo therapy, based on studies done before.

The EG will do weekly office-based therapy of 45 minutes during 12 weeks and the CG will do weekly office-based placebo therapy of 15 minutes during 12 weeks. This placebo therapy will consist of smooth-pursuit and discrimination exercises that do not influence vergence response. The office-based done by the EG consists of a vergence therapy and its protocol will follow Scheiman's indications protocol. This vision therapy will train both positive and negative fusional vergence amplitudes in the same proportion.

A pre-evaluation, a during evaluation, and a post-evaluation will be done at weeks 1, 6, and 12 respectively to all subjects. After the post-evaluation week, the CG will do 12 weeks more of office-based therapy but, this group will do the same conventional vergence protocol as EG. The CG will be evaluated at week 18, and finally, at week 24.

During the evaluations, the vergence eye movements will be measured during the positive and negative fusional vergence tests. The break and the recovery points will be evaluated to all the subjects with three different methods performed in a randomized order: (1) objective computer-based test in the haploscopic system, (2) prism bar, and (3) phoropter rotary prisms. All these tests will be performed at 40 cm with a classic central visual target.

This study aims to evaluate objectively the change in the vergence responses of binocular and accommodative normal subjects after performing a classic vision therapy protocol.

Conditions

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Vision Disorders Eye; Movement Disorder (Binocular) Vision Therapy Binocular Vision Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Classical Vision Therapy Treatment: vision therapy exercises for fusional vergence abilities

The Experimental Group (EG) it consist in a Classical Vision Therapy Treatment. This group will do weekly office-based therapy of 45 minutes of visual exercises during 12 weeks. The office-based done by the EG consists of a vergence therapy and its protocol will follow Scheiman's Protocol and Indications.

The exercises do not tough the eye or use drugs. They are just visual training exercises that improve fusional convergence and divergence response.

Group Type EXPERIMENTAL

Experimental: Classical Vision Therapy Treatment

Intervention Type OTHER

Do classical vision therapy treatment for improve vergence

Eye Movement Therapy Treatment: vision therapy placebo exercises not improve fusional vergence

The Control Group or Placebo Group consist in a Control: Eye Movement Therapy Treatment. This group will do weekly office-based placebo therapy of 15 minutes during 12 weeks of visual exercises. This placebo therapy will consist of smooth-pursuit and discrimination exercises that do not influence vergence response.

The exercises do not tough the eye nor use drugs. They are just visual training exercises that do not improve fusional vergence response as they improve smooth-pursuit eye movements.

Group Type PLACEBO_COMPARATOR

Experimental: Classical Vision Therapy Treatment

Intervention Type OTHER

Do classical vision therapy treatment for improve vergence

Control: Eye Movement Therapy Treatment

Intervention Type OTHER

Do eye movement therapy treatment in order not to improve vergence

Interventions

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Experimental: Classical Vision Therapy Treatment

Do classical vision therapy treatment for improve vergence

Intervention Type OTHER

Control: Eye Movement Therapy Treatment

Do eye movement therapy treatment in order not to improve vergence

Intervention Type OTHER

Other Intervention Names

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Vision therapy protocol Vision therapy protocol

Eligibility Criteria

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Inclusion Criteria

1. Monocular and binocular VA at near and distance with their habitual correction
2. Refractive error measured with the Grand Seiko WAM-5500 Autorefractor
3. Cover Test at near (40 cm)
4. Near Point of Accommodation
5. Near Point of Convergence
6. Vergence Facility Test at near (40 cm)
7. Monocular and binocular Accommodation Facility Test at near (40 cm)
8. Negative and Positive Relative Accommodation Test (ARN and ARP)
9. Random Dot 2 Stereo acuity Test
10. CISS questionnaire
11. Fusional Vergence Amplitude using both subjective and objective methods