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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental: Classical Vision Therapy Treatment
Control: Eye Movement Therapy Treatment
Sponsored by
Universitat Politècnica de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vision Disorders focused on measuring Vergence, Vision Therapy, Binocular Vision

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cristina Rovira-GayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2021
Last Updated
January 25, 2022
Sponsor
Universitat Politècnica de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05208658
Brief Title
Characteristics of the Vergence Responses of Binocularly Normal Subjects After a Vision Therapy Protocol
Official Title
Evaluate Objectively the Change in the Vergence Responses of Binocular and Accommodative Normal Subjects After Performing a Classic Vision Therapy Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Anticipated)
Study Completion Date
March 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Politècnica de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders, Eye; Movement Disorder (Binocular), Vision Therapy, Binocular Vision Disorder
Keywords
Vergence, Vision Therapy, Binocular Vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classical Vision Therapy Treatment: vision therapy exercises for fusional vergence abilities
Arm Type
Experimental
Arm Description
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.
Arm Title
Eye Movement Therapy Treatment: vision therapy placebo exercises not improve fusional vergence
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: Classical Vision Therapy Treatment
Other Intervention Name(s)
Vision therapy protocol
Intervention Description
Do classical vision therapy treatment for improve vergence
Intervention Type
Other
Intervention Name(s)
Control: Eye Movement Therapy Treatment
Other Intervention Name(s)
Vision therapy protocol
Intervention Description
Do eye movement therapy treatment in order not to improve vergence
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
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
Description
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.
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Monocular and binocular VA at near and distance with their habitual correction Refractive error measured with the Grand Seiko WAM-5500 Autorefractor Cover Test at near (40 cm) Near Point of Accommodation Near Point of Convergence Vergence Facility Test at near (40 cm) Monocular and binocular Accommodation Facility Test at near (40 cm) Negative and Positive Relative Accommodation Test (ARN and ARP) Random Dot 2 Stereo acuity Test CISS questionnaire 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
Facility Information:
Facility Name
Cristina Rovira-Gay
City
Barcelona
ZIP/Postal Code
08222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Rovira-Gay
Phone
610072514
Email
cristina.rovira@upc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet decided.
Citations:
PubMed Identifier
15642806
Citation
Scheiman M, Mitchell GL, Cotter S, Cooper J, Kulp M, Rouse M, Borsting E, London R, Wensveen J; Convergence Insufficiency Treatment Trial Study Group. A randomized clinical trial of treatments for convergence insufficiency in children. Arch Ophthalmol. 2005 Jan;123(1):14-24. doi: 10.1001/archopht.123.1.14.
Results Reference
result
PubMed Identifier
30570596
Citation
Scheiman M, Talasan H, Alvarez TL. Objective Assessment of Disparity Vergence after Treatment of Symptomatic Convergence Insufficiency in Children. Optom Vis Sci. 2019 Jan;96(1):3-16. doi: 10.1097/OPX.0000000000001320.
Results Reference
result
PubMed Identifier
31640452
Citation
Alvarez TL, Scheiman M, Santos EM, Morales C, Yaramothu C, D'Antonio-Bertagnolli JV, Biswal BB, Gohel S, Li X. The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data. Ophthalmic Epidemiol. 2020 Feb;27(1):52-72. doi: 10.1080/09286586.2019.1679192. Epub 2019 Oct 22.
Results Reference
result
PubMed Identifier
16044063
Citation
Scheiman M, Mitchell GL, Cotter S, Kulp MT, Cooper J, Rouse M, Borsting E, London R, Wensveen J. A randomized clinical trial of vision therapy/orthoptics versus pencil pushups for the treatment of convergence insufficiency in young adults. Optom Vis Sci. 2005 Jul;82(7):583-95. doi: 10.1097/01.opx.0000171331.36871.2f.
Results Reference
result
PubMed Identifier
29577409
Citation
Scheiman M, Chase C, Borsting E, Mitchell GL, Kulp MT, Cotter SA; CITT-RS Study Group. Effect of treatment of symptomatic convergence insufficiency on reading in children: a pilot study. Clin Exp Optom. 2018 Jul;101(4):585-593. doi: 10.1111/cxo.12682. Epub 2018 Mar 25.
Results Reference
result
PubMed Identifier
18852411
Citation
Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336.
Results Reference
result

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

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