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

January 25, 2022 updated by: Cristina Rovira Gay, Universitat Politècnica de Catalunya

Evaluate Objectively the Change in the Vergence Responses of Binocular and Accommodative Normal Subjects After Performing a Classic Vision Therapy Protocol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08222
        • Recruiting
        • Cristina Rovira-Gay
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Normal binocular and accommodative subjects will participate in the study. All subjects have to fulfill the inclusion criteria. All evaluations will consist of the following objective and subjective optometric tests, which will be executed for all participants.

  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

Exclusion Criteria:

  • having eye surgery
  • having an eye pathology
  • having a binocular or an accommodative disorder
  • using orto-K lenses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Experimental: Classical Vision Therapy Treatment
Do classical vision therapy treatment for improve vergence
Other Names:
  • Vision therapy protocol
Placebo Comparator: 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.
Other: Experimental: Classical Vision Therapy Treatment
Do classical vision therapy treatment for improve vergence
Other Names:
  • Vision therapy protocol
Other: Control: Eye Movement Therapy Treatment
Do eye movement therapy treatment in order not to improve vergence
Other Names:
  • Vision therapy protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective vergence response: To evaluate objectively the change in positive and negative fusional vergence at near of binocularly and accommodative normal subjects after performing a vision therapy
Time Frame: Through study completion, an average of 6 months

It is measured objectively with an haparoscopic setup and eye movements were recorded with an Eyelink 1000 Plus (SR Research) at 500Hz. Firstly, stimulus disparity changed smoothly at 1PD/s up to 45PD for both divergence (BI) and convergence (BO), mimicking a Risley prism. Secondly, the disparity was changed in steps of 2PD mimicking a prism bar. Break and recovery points were determined offline using a custom Matlab code for the analysis of eye movements.

Measurements will be compared before and after the therapy treatment.
Through study completion, an average of 6 months
Subjective vergence response: To evaluate objectively the change in positive and negative fusional vergence at near of binocularly and accommodative normal subjects after performing a vision therapy
Time Frame: Through study completion, an average of 6 months

It is evaluated with the clinical methods measured subjectively using the Risley prism of the phoropter and the Prism Bar.

Measurements will be compared before and after the therapy treatment.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Politècnica de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2021

Primary Completion (Anticipated)

March 29, 2022

Study Completion (Anticipated)

March 29, 2022

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vergence VT Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is not yet decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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