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Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

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ClinicalTrials.gov Identifier: NCT03431454
Recruitment Status : Unknown
Verified December 2017 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Comparison of Three Vision Therapy Approaches for Convergence Insufficiency Procedure: trained to do the pencil push-ups procedure Procedure: using a major amblyoscope twice weekly with additional home orthoptic therapy Procedure: using three diopter over-minus lenses and a base out prism Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: home-based vision orthoptic therapy (HBVOT) group
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
Procedure: trained to do the pencil push-ups procedure
15 minutes per day, five days a week

Active Comparator: office-based vision orthoptic therapy (OBVOT) group
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
Procedure: using a major amblyoscope twice weekly with additional home orthoptic therapy
60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed.

Active Comparator: augmented office-based vision orthoptic therapy (AOBVOT) group
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.
Procedure: using three diopter over-minus lenses and a base out prism
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.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431454


Contacts
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Contact: Maryam Aletaha, MD 9822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Maryam Aletaha, MD    9822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03431454    
Other Study ID Numbers: 92149
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ocular Motility Disorders
Central Nervous System Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases