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

NCT05208658 | Unknown

• 1 other identifier: Vergence VT Protocol
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Vergence; Vision Therapy; Binocular Vision

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Study Arms (2)

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

EXPERIMENTAL

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

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

PLACEBO COMPARATOR

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; Other: Control: Eye Movement Therapy Treatment

Interventions

Experimental: Classical Vision Therapy Treatment OTHER

Do classical vision therapy treatment for improve vergence

Also known as: Vision therapy protocol

Classical Vision Therapy Treatment: vision therapy exercises for fusional vergence abilities; Eye Movement Therapy Treatment: vision therapy placebo exercises not improve fusional vergence

Control: Eye Movement Therapy Treatment OTHER

Do eye movement therapy treatment in order not to improve vergence

Also known as: Vision therapy protocol

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

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Politècnica de Catalunya: lead

Study Sites (1)

Cristina Rovira-Gay

Barcelona, 08222, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 15642806 RESULT

• 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.

  PMID: 30570596 RESULT

• 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.

  PMID: 31640452 RESULT

• 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.

  PMID: 16044063 RESULT

• 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.

  PMID: 29577409 RESULT

• 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.

  PMID: 18852411 RESULT

MeSH Terms

Conditions

Vision Disorders; Esotropia

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Predoctoral student

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: January 26, 2022
• Study Start: September 2, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

ES (1)