Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
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ClinicalTrials.gov Identifier: NCT03248336 |
Recruitment Status :
Recruiting
First Posted : August 14, 2017
Last Update Posted : October 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Convergence Insufficiency | Procedure: office-based vergence/accommodative therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Eligible participants received 12 weeks of office vergence/accommodative therapy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children |
Actual Study Start Date : | September 2, 2018 |
Estimated Primary Completion Date : | September 1, 2022 |
Estimated Study Completion Date : | December 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Vision therapy group
Twelve, 60-minute, weekly visits of office-based vergence/accommodation therapy will be administered by a trained therapist combined with procedures to practice at home (15 minutes, 5 times per week). This treatment sequence is a well-accepted approach for treatment of CI and has been successfully implemented in previous studies. Fifteen minutes of home-based therapy was prescribed to be performed 5 days per week, and compliance with home-based therapy was monitored at each visit by the therapist
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Procedure: office-based vergence/accommodative therapy
one -to-one treatment by a trained therapists. The subject is asked to perform 5-6 therapy procedures during a 60 minute therapy session. The subject is also asked to perform 15 minutes per day of home-based therapy.
Other Name: optometric vision therapy |
- Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: After 12 weeks of therapy ]The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and the primary outcome measures will be the change in average peak velocity for 4° symmetrical convergence steps
- Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: After 12 weeks of therapy ]The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in time to peak velocity for 4° symmetrical convergence steps
- Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: After 12 weeks of therapy ]The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in latency for 4° symmetrical convergence steps
- Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: After 12 weeks of therapy ]The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in accuracy for 4° symmetrical convergence steps
- Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy [ Time Frame: After 12 weeks of therapy ]The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and a secondary outcome measures will be the change in settling time for 4° symmetrical convergence steps
- Change in the near point of convergence [ Time Frame: After 12 weeks of therapy ]The near point of convergence will be measured using the Near Point Rule at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.
- Change in the positive fusional vergence [ Time Frame: After 12 weeks of therapy ]Positive fusional vergence will be measured using a handheld target placed 40 cm from the participant and using a horizontal prism bar. Positive fusional vergence will be measured at baseline and after 12 weeks of therapy. The change in this measurement will a secondary clinical outcome measure.

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Ages Eligible for Study: | 9 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- CI Symptom Survey score ≥ 16
- Exophoria at near at least 4 greater than at far
- Receded near point of convergence (NPC) of 6 cm break
- Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion or PFV ≤15 base-out break)
- Best-corrected distance visual acuity of 20/25 or better in each eye
- Random dot stereopsis appreciation of 500 seconds of arc or better
- Wearing appropriate refractive correction (spectacles of contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)
- No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
Exclusion Criteria:
- Constant strabismus at distance or near
- Esophoria of ≥ 2∆ at distance
- Vertical heterophoria ≥ 2∆ at distance or near
- ≥ 2 line interocular difference in best-corrected visual acuity
- Near point of accommodation >20 cm in either eye as measured by push-up method
- Manifest or latent nystagmus
- History of strabismus surgery or refractive surgery
- CI associated with head trauma or known disease of the brain
- Diseases known to affect accommodation, vergence, or ocular motility
- Inability to comprehend and/or perform any study-related test

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): NCT03248336
Contact: Mitchell Scheiman, OD, PhD | 215-692-0897 | scheiman@comcast.net |
United States, Pennsylvania | |
Salus University | Recruiting |
Philadelphia, Pennsylvania, United States, 19141 | |
Contact: Mitchell Scheiman, OD, PhD 215-692-0897 mscheiman@salus.edu |
Responsible Party: | Mitchell Scheiman, Dean of Research, Salus University |
ClinicalTrials.gov Identifier: | NCT03248336 |
Other Study ID Numbers: |
HMS1312 |
First Posted: | August 14, 2017 Key Record Dates |
Last Update Posted: | October 23, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ocular Motility Disorders Central Nervous System Diseases Nervous System Diseases Cranial Nerve Diseases Eye Diseases |