Convergence InsufficiencyNCT03248336
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
A study testing office-based vergence/accommodative therapy in people with Convergence Insufficiency, run by Salus University at 1 site in United States.
Trial summary
This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- office-based vergence/accommodative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2018to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Salus University
Philadelphia, Pennsylvania, 19141
Mitchell Scheiman, OD, PhD, 215-692-0897, mscheiman@salus.edu
About this study
Official title: Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children
This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old.
Read the detailed description
30 participants with normal binocular vision and 30 with CI will be recruited for this prospective study. All participants with CI will be treated with 12 weeks of office-based vergence/accommodative therapy. The primary outcome measure will be the average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence will be time to peak velocity, latency, and accuracy. Changes in clinical measures [near point of convergence (NPC), positive fusional vergence at near (PFV)] and symptoms will be evaluated.
- Conditions
- Convergence Insufficiency
- Being tested
- office-based vergence/accommodative therapy
- Medical subject headings
- Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office-based vergence/accommodative therapyProcedure or surgery
Also called optometric vision 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.
| Study group | Role | What they receive |
|---|---|---|
| Vision therapy group | Experimental | 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 Receives: Procedure: office-based vergence/accommodative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average peak velocity for 4° symmetrical convergence steps 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
Measured: After 12 weeks of therapy
Secondary outcomes (6)
Change in time to peak velocity for 4° symmetrical convergence steps 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
Measured: After 12 weeks of therapy
Change in latency for 4° symmetrical convergence steps 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
Measured: After 12 weeks of therapy
Change in accuracy for 4° symmetrical convergence steps 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
Measured: After 12 weeks of therapy
Change in settling time for 4° symmetrical convergence steps 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
Measured: After 12 weeks of therapy
Change in the near point of convergence
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.
Measured: After 12 weeks of therapy
Change in the positive fusional vergence
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.
Measured: After 12 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start2 Sep 2018
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convergence InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible participants received 12 weeks of office vergence/accommodative therapy
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Scheiman, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248336
- Sponsor's protocol ID
- HMS1312
- Status last verified
- Oct 2020
- First submitted
- 7 Aug 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children
- ClinicalTrials.gov ID
- NCT03248336
- Acronym / sponsor ID
- HMS1312
- Conditions
- Convergence Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old.
Detailed description
30 participants with normal binocular vision and 30 with CI will be recruited for this prospective study. All participants with CI will be treated with 12 weeks of office-based vergence/accommodative therapy. The primary outcome measure will be the average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence will be time to peak velocity, latency, and accuracy. Changes in clinical measures [near point of convergence (NPC), positive fusional vergence at near (PFV)] and symptoms will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible participants received 12 weeks of office vergence/accommodative therapy
| Arm | Type | Receives |
|---|---|---|
| Vision therapy group | Experimental | Procedure: office-based vergence/accommodative therapyTwelve, 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 |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| office-based vergence/accommodative therapyAlso: optometric vision therapyone -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. | Procedure or surgery | Vision therapy group |
Primary outcome
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
6 secondary outcomes
Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
Time frame: After 12 weeks of therapy
Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy
Time frame: After 12 weeks of therapy
Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy
Time frame: After 12 weeks of therapy
Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy
Time frame: After 12 weeks of therapy
Change in the near point of convergence
Time frame: After 12 weeks of therapy
Change in the positive fusional vergence
Time frame: After 12 weeks of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing office-based vergence/accommodative therapy in people with Convergence Insufficiency, run by Salus University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitchell Scheiman, OD, PhD (215-692-0897, scheiman@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy (time frame: After 12 weeks of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.