Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12:CD006768. doi: 10.1002/14651858.CD006768.pub3.

• 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
• Last Update Posted: February 13, 2018
• Last Verified: December 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ocular Motility Disorders; Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases