Convergence InsufficiencyPhase 3CITT-ARTNCT02207517
Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency
A Phase 3 study testing Office-based vergence/accommodative therapy in people with Convergence Insufficiency, run by Salus University at 8 sites in United States.
Trial summary
CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. Read more about this study
- Who is it for?
- Ages 9 to 13 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?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2014to Nov 2020
- Phase
- Phase 3
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 9 to less than 14 years
- Grades 3 through 8
- CI Symptom Survey (CISS) score greater or equal to 16
- Exophoria at near at least 4 prism diopters greater than at far
- Receded near point of convergence (NPC) of 6 cm or greater break
- Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's or PFV less than or equal to 15 BO break)
Show all 23Show fewer
- 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 or 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)
- Myopia greater than -0.75D spherical equivalent (SE) in either eye
- Hyperopia greater than +2.00D SE in either eye
- SE anisometropia greater than 0.75D
- Astigmatism greater than 1.00D in either eye
- Correction for patients meeting above refractive error criteria must meet the following guidelines:
- SE anisometropia must be within 0. 75D of the full anisometropic correction
- Astigmatism must be within 0.75D of full correction; axis must be within 6◦ if astigmatism greater than or equal to 1.00D
- For hyperopia, the sphere can be reduced by up to 1.50 D provided reduction is symmetrical
- For myopia, the SE must be within 0.75D of the full myopic correction
- No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
- English is primary language spoken at home or child proficient in English as determined by the school
- Parent does not expect child to start any new ADHD medicine or change the dose of any currently taken ADHD medicine while child is being treated in the study
- Parental permission to contact the child's teacher(s) for study purposes
- Parent and child understand protocol and are willing to accept randomization
Who cannot join
- Constant strabismus at distance or near
- Esophoria of greater than or equal to 2∆ at distance
- Vertical heterophoria greater than or equal to 2∆ at distance or near
- greater than or equal to 2 line interocular difference in best-corrected distance visual acuity
- Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye
- Manifest or latent nystagmus
Show all 17Show fewer
- Word Reading subtest score less than 80 on the Wide Range Achievement Test (WRAT-4)
- Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score less than 70
- History of prior strabismus, intraocular, or refractive surgery
- CI previously treated with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
- 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 or therapy procedure
- Speech-language disorder (e.g., stuttering) that would interfere with interpretation of digital recordings of reading tests
- Significant hearing loss
- Household member enrolled in present CITT-ART, treated currently, or treated within the past 6 months with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
- Parent or other household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident, or optometry student
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Akron Children's Hospital
Akron, Ohio, 44302
University of Alabama, Birmingham College of Optometry
Birmingham, Alabama, 35294
Ohio State University College of Optometry
Columbus, Ohio, 43210
NOVA Southeastern University College of Optometry
Fort Lauderdale, Florida, 33314
Southern California College of Optometry Marshall B. Ketchum University
Fullerton, California, 90037
Bascom Palmer Eye Institute
Miami, Florida, 33136
State University of Optometry College of Optometry
New York, New York, 10036
Pennsylvania College of Optometry at Salus University
Philadelphia, Pennsylvania, 19141
About this study
Official title: Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)
CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention
Read the detailed description
Following the success of the NEI-funded Convergence Insufficiency Treatment Trials (CITT), the next logical and important research issue is to determine if the successful treatment of symptomatic convergence insufficiency (CI) (i.e., improvement of symptoms and ophthalmic signs) impacts function (reading and attention).
It is well documented that children with symptomatic CI report significantly more symptoms when reading and doing close work (e.g., blurred vision, headaches, double vision, loss of concentration, frequent loss of place, trouble remembering what was read), manifest more academic-impairing behaviors (e.g., difficulty finishing assignments), and score worse on parent ratings of attention compared to children with normal binocular vision. Because reduction of symptoms and adverse academic behaviors are established outcomes of successful treatment of CI, we propose to test the hypothesis that resolution of these symptoms and behaviors leads to improved reading performance and attention. Previous studies have found improvements in reading comprehension reading speed and accuracy after successful treatment of CI. In a recent pilot study, investigators also found significant improvement in reading comprehension and attention after 16 weeks of successful treatment of symptomatic CI with office-based vergence/accommodative therapy; however, there was no control group. To definitively determine whether the successful treatment of symptomatic CI positively impacts reading and attention requires a placebo-controlled randomized clinical trial.
Objective: We propose a multicenter, placebo-controlled, randomized clinical trial (RCT) of 324 children ages 9 to <14 years (Grades 3-8) with symptomatic CI. [we will restrict recruitment to children who do not have significant single word reading deficits.] Participants will be randomized to 16 weeks of treatment with either [a] office-based vergence/accommodative therapy with home reinforcement (OBVAT) or [b] office-based placebo therapy with home reinforcement (OBPT). Outcomes (reading and attention) will be assessed after 16 weeks of treatment. In addition, we will test the long-term effects on outcomes at 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups.
Specific Aim 1 - Reading Performance: To compare reading comprehension outcomes for children with symptomatic CI who receive 16 weeks of OBVAT and OBPT treatment. The primary outcome measure of reading performance is the Wechsler Individual Achievement test (WIAT-III) reading comprehension subtest score. In secondary analyses, we will examine the effects of the treatment on word reading, pseudoword decoding, oral reading fluency, and listening comprehension. We also will examine the correlation of changes in CI symptoms and ophthalmic signs with reading outcomes. Analysis of the 1-year follow-up data will be used to determine if any gains in reading performance observed after 16 weeks of treatment are sustained.
Specific Aim 2 - Attention: To investigate the effect of treatment on teacher- and parent-rated measures of attention for children with symptomatic CI who receive 16 weeks of OBVAT and OBPT intervention. The primary outcome measure of attention is the score on the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN). In secondary analyses, we will examine the effects of treatment on a second parent-rated attention scale called the SNAP. We also will examine the correlation of changes in CI-symptoms and ophthalmic signs with attention outcomes. Analysis of the 1-year follow-up data will be used to determine if any gains in attention observed after 16 weeks of treatment are maintained.
Scientific and Clinical Impact: The relationship between the treatment of symptomatic CI and its effect on reading and attention in children is unknown. The results of the proposed study will contribute to a better understanding of these relationships and help to resolve controversy surrounding this issue. The results will have important implications for educators, psychologists, eye professionals, and other health care providers who care for children with reading and attention problems and guide hypothesis development for future scientific investigations on evidence-based relationships between visual disorders and other developmental disorders in children.
- Conditions
- Convergence Insufficiency
- Being tested
- Office-based vergence/accommodative therapy
- Keywords
- convergence insufficiency, vision therapy, reading, attention
- 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 Vision Therapy, Orthoptics
The OBVAT program has been divided into 4 phases. Within each phase there are a number of categories such as gross convergence, vergence, and accommodation. The therapy procedures in each category have been arranged sequentially from easiest to most difficult
| Study group | Role | What they receive |
|---|---|---|
| Office-based verg/accomm therapy (OBVAT) | Experimental | OBVAT requires a participant to undergo a specific vision therapy regimen with 16 weekly, 60-minute in-office treatment sessions. Vision Therapists (O.D., M.D., Orthoptists, or specially-trained technicians) administer the therapy in the office. OBVAT procedures are then supplemented with various home therapy procedures Receives: Procedure: Office-based vergence/accommodative therapy |
| Office-based placebo therapy (OBPT) | Placebo comparator | Office-based Placebo Therapy (OBPT) requires a participant to undergo a specific therapy regimen of 16 weekly, 60 minute, in-office treatment sessions. Vision therapists (optometrists, ophthalmologists, orthoptists, or specially-trained technicians) administer the therapy in the office. OBPT procedures are then supplemented with placebo home therapy procedures.
The procedures for OBPT are designed with the intent of not providing a beneficial training effect on vergence, accommodation, saccadic accuracy, or visual attention beyond normal activities. However, the procedures are designed to simulate real vision therapy in such a way that it will be difficult for participants and parents to know that they have been assigned to the control group and thus are not receiving bonafide OBVAT Receives: Procedure: Office-based vergence/accommodative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT).
This test requires the examinee to respond to multiple-choice questions after having read passages independently.
Measured: After 16 weeks of treatment
Secondary outcomes (5)
The change in the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN)
The SWAN is a behavior rating scale that has been used for many years as an assessment tool for ADHD.
Measured: After 16 weeks of treatment
Gates-McGintie 4
The child must respond to multiple-choice questions after having read passages independently
Measured: After 16 weeks of treatment
d2 Test of Attention
The d2 is a timed test of selective and sustained attention.The test measures processing speed, rule compliance, and quality of performance in response to the discrimination of similar stimuli, thereby allowing for an estimation of individual attention and concentration performance
Measured: After 16 weeks of treatment
Academic Behavior Survey (ABS)
The ABS is a 6-item survey designed to measure the frequency of adverse academic behaviors and parental worry about academic performance.
Measured: After 16 weeks of treatment
Curriculum Based Measurement (CBM)
Curriculum Based Measurement is commonly used by educators to assess short-term progress in reading, skills as the child proceeds through the academic year The primary advantage of the CBM measure is the ability to track rate of improvement by initial reading level and by time of year. The addition of the CBM measure will assess reading at each outcome visit and allow us to track changes in a similar manner to attention and CI where we have measures at each outcome visit. In addition, CBM will provide an additional outcome measure for reading using a method that is commonly employed by school districts to monitor reading progress and will help to communicate the clinical significance of our results.
Measured: After 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2017
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Marshall B. Ketchum University, Ohio State University, University of Alabama at Birmingham, State University of New York College of Optometry, Akron Children's Hospital, Nova Southeastern University, Bascom Palmer Eye Institute
- Responsible party
- Principal investigator, Mitchell Scheiman, Salus University
- Investigators
- Mitchell Scheiman, OD, Study chair, Salus UniversityLynn MItchell, MAS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207517
- Sponsor's protocol ID
- Salus - HMS1310
- Other IDs
- U10EY022599-01A1
- Acronym
- CITT-ART
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
CITT-ART Investigator Group. Effect of Vergence/Accommodative Therapy on Attention in Children with Convergence Insufficiency: A Randomized Clinical Trial. Optom Vis Sci. 2021 Mar 1;98(3):222-233. doi: 10.1097/OPX.0000000000001659.
PubMed 33771952Scheiman 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(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
PubMed 33263359CITT-ART Investigator Group. Effect of Vergence/Accommodative Therapy on Reading in Children with Convergence Insufficiency: A Randomized Clinical Trial. Optom Vis Sci. 2019 Nov;96(11):836-849. doi: 10.1097/OPX.0000000000001442.
PubMed 31651592
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)
- ClinicalTrials.gov ID
- NCT02207517
- Acronym / sponsor ID
- CITT-ART / Salus - HMS1310
- Conditions
- Convergence Insufficiency
- Keywords
- convergence insufficiency, vision therapy, reading, attention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Marshall B. Ketchum University, Ohio State University, University of Alabama at Birmingham, State University of New York College of Optometry, Akron Children's Hospital, Nova Southeastern University, Bascom Palmer Eye Institute
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Nov 2020 (estimated)
- First posted
- 4 Aug 2014 (estimated)
- 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.
CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention
Detailed description
Following the success of the NEI-funded Convergence Insufficiency Treatment Trials (CITT), the next logical and important research issue is to determine if the successful treatment of symptomatic convergence insufficiency (CI) (i.e., improvement of symptoms and ophthalmic signs) impacts function (reading and attention).
It is well documented that children with symptomatic CI report significantly more symptoms when reading and doing close work (e.g., blurred vision, headaches, double vision, loss of concentration, frequent loss of place, trouble remembering what was read), manifest more academic-impairing behaviors (e.g., difficulty finishing assignments), and score worse on parent ratings of attention compared to children with normal binocular vision. Because reduction of symptoms and adverse academic behaviors are established outcomes of successful treatment of CI, we propose to test the hypothesis that resolution of these symptoms and behaviors leads to improved reading performance and attention. Previous studies have found improvements in reading comprehension reading speed and accuracy after successful treatment of CI. In a recent pilot study, investigators also found significant improvement in reading comprehension and attention after 16 weeks of successful treatment of symptomatic CI with office-based vergence/accommodative therapy; however, there was no control group. To definitively determine whether the successful treatment of symptomatic CI positively impacts reading and attention requires a placebo-controlled randomized clinical trial.
Objective: We propose a multicenter, placebo-controlled, randomized clinical trial (RCT) of 324 children ages 9 to <14 years (Grades 3-8) with symptomatic CI. [we will restrict recruitment to children who do not have significant single word reading deficits.] Participants will be randomized to 16 weeks of treatment with either [a] office-based vergence/accommodative therapy with home reinforcement (OBVAT) or [b] office-based placebo therapy with home reinforcement (OBPT). Outcomes (reading and attention) will be assessed after 16 weeks of treatment. In addition, we will test the long-term effects on outcomes at 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups.
Specific Aim 1 - Reading Performance: To compare reading comprehension outcomes for children with symptomatic CI who receive 16 weeks of OBVAT and OBPT treatment. The primary outcome measure of reading performance is the Wechsler Individual Achievement test (WIAT-III) reading comprehension subtest score. In secondary analyses, we will examine the effects of the treatment on word reading, pseudoword decoding, oral reading fluency, and listening comprehension. We also will examine the correlation of changes in CI symptoms and ophthalmic signs with reading outcomes. Analysis of the 1-year follow-up data will be used to determine if any gains in reading performance observed after 16 weeks of treatment are sustained.
Specific Aim 2 - Attention: To investigate the effect of treatment on teacher- and parent-rated measures of attention for children with symptomatic CI who receive 16 weeks of OBVAT and OBPT intervention. The primary outcome measure of attention is the score on the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN). In secondary analyses, we will examine the effects of treatment on a second parent-rated attention scale called the SNAP. We also will examine the correlation of changes in CI-symptoms and ophthalmic signs with attention outcomes. Analysis of the 1-year follow-up data will be used to determine if any gains in attention observed after 16 weeks of treatment are maintained.
Scientific and Clinical Impact: The relationship between the treatment of symptomatic CI and its effect on reading and attention in children is unknown. The results of the proposed study will contribute to a better understanding of these relationships and help to resolve controversy surrounding this issue. The results will have important implications for educators, psychologists, eye professionals, and other health care providers who care for children with reading and attention problems and guide hypothesis development for future scientific investigations on evidence-based relationships between visual disorders and other developmental disorders in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office-based verg/accomm therapy (OBVAT) | Experimental | Procedure: Office-based vergence/accommodative therapyOBVAT requires a participant to undergo a specific vision therapy regimen with 16 weekly, 60-minute in-office treatment sessions. Vision Therapists (O.D., M.D., Orthoptists, or specially-trained technicians) administer the therapy in the office. OBVAT procedures are then supplemented with various home therapy procedures |
| Office-based placebo therapy (OBPT) | Placebo comparator | Procedure: Office-based vergence/accommodative therapyOffice-based Placebo Therapy (OBPT) requires a participant to undergo a specific therapy regimen of 16 weekly, 60 minute, in-office treatment sessions. Vision therapists (optometrists, ophthalmologists, orthoptists, or specially-trained technicians) administer the therapy in the office. OBPT procedures are then supplemented with placebo home therapy procedures. The procedures for OBPT are designed with the intent of not providing a beneficial training effect on vergence, accommodation, saccadic accuracy, or visual attention beyond normal activities. However, the procedures are designed to simulate real vision therapy in such a way that it will be difficult for participants and parents to know that they have been assigned to the control group and thus are not receiving bonafide OBVAT |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- Age 9 to less than 14 years
- Grades 3 through 8
- CI Symptom Survey (CISS) score greater or equal to 16
- Exophoria at near at least 4 prism diopters greater than at far
- Receded near point of convergence (NPC) of 6 cm or greater break
Key exclusion criteria (17 listed)
- Constant strabismus at distance or near
- Esophoria of greater than or equal to 2∆ at distance
- Vertical heterophoria greater than or equal to 2∆ at distance or near
- greater than or equal to 2 line interocular difference in best-corrected distance visual acuity
- Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye
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: Vision Therapy, OrthopticsThe OBVAT program has been divided into 4 phases. Within each phase there are a number of categories such as gross convergence, vergence, and accommodation. The therapy procedures in each category have been arranged sequentially from easiest to most difficult | Procedure or surgery | Office-based placebo therapy (OBPT), Office-based verg/accomm therapy (OBVAT) |
Primary outcome
The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT).
Time frame: After 16 weeks of treatment
This test requires the examinee to respond to multiple-choice questions after having read passages independently.
5 secondary outcomes
The change in the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN)
Time frame: After 16 weeks of treatment
Gates-McGintie 4
Time frame: After 16 weeks of treatment
d2 Test of Attention
Time frame: After 16 weeks of treatment
Academic Behavior Survey (ABS)
Time frame: After 16 weeks of treatment
Curriculum Based Measurement (CBM)
Time frame: After 16 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 33771952CITT-ART Investigator Group. Effect of Vergence/Accommodative Therapy on Attention in Children with Convergence Insufficiency: A Randomized Clinical Trial. Optom Vis Sci. 2021 Mar 1;98(3):222-233. doi: 10.1097/OPX.0000000000001659.
- Derived from this study: PubMed 33263359Scheiman 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(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
- Derived from this study: PubMed 31651592CITT-ART Investigator Group. Effect of Vergence/Accommodative Therapy on Reading in Children with Convergence Insufficiency: A Randomized Clinical Trial. Optom Vis Sci. 2019 Nov;96(11):836-849. doi: 10.1097/OPX.0000000000001442.
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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.
Mitchell Scheiman, OD study chair
Salus University
Lynn MItchell, MAS principal investigator
Ohio State University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Office-based vergence/accommodative therapy in people with Convergence Insufficiency, run by Salus University at 8 sites 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 23 inclusion and 17 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT). (time frame: After 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207517, which also lists 3 linked publications.
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 17 Mar 2020.