ConcussionPhase 3ICONICCNCT03908112
Interventions for Convergence Insufficiency in Concussed Children
A Phase 3 study testing Standard Community Concussion Care (SC), SC plus Simple Convergence Exercises (SC+) and SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT) in people with Concussion and Convergence Insufficiency, run by Mitchell Scheiman at 8 sites in United States.
Trial summary
The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Convergence Insufficiency
- What is being tested?
- Standard Community Concussion Care (SC), SC plus Simple Convergence Exercises (SC+) and SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Apr 2021to 31 Mar 2025
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ICONICC will enroll children of all races and will adhere to a policy of equitability. To be eligible to participate in ICONICC, the child must meet all of the following criteria:
- Medical diagnosis of concussion of at least 4 weeks and no longer than 12 weeks since known date of injury
- Age 11 to 17 years
- Gender - any
- CI Symptom Survey (CISS) score ≥ 16
- Exophoria at near at least 4∆ greater than at far
Show all 18Show fewer
- Receded near point of convergence (NPC) of greater than 6 cm break
- Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion1 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 using the Randot Stereotest
- Willing to wear refractive correction for any of the following uncorrected refractive errors based on a cycloplegic refraction performed at the eligibility examination. (Correction must be worn for at least 2 weeks):
- Myopia > -0.75 D spherical equivalent in either eye
- Hyperopia > 2.00 D spherical equivalent in either eye
- Anisometropia > 0.75D spherical equivalent or ≥ 1.50 D in any meridian
- Astigmatism > 1.00 D in either eye
- Willing to discontinue BI prism or a plus add at near for duration of study (must discontinue at least 2 weeks before eligibility examination)
- Parent and child understand protocol and are willing to accept randomization
- Normal pupillary responses
Who cannot join
- Any strabismus at distance
- Constant strabismus at near
- Limitation on versions/ductions due to restrictive or paretic strabismus
- Esophoria of ≥ 2∆ at distance
- Vertical heterophoria ≥ 2∆ at distance or near
- ≥ 2 line interocular difference in best-corrected visual acuity
Show all 13Show fewer
- Manifest or latent nystagmus
- History of surgery or botulinum toxin for strabismus or any type of refractive surgery
- Previous diagnosis of CI by an eye care professional before concussion
- Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson's disease
- Inability to comprehend and/or perform any study-related, clinical vision function test
- Household member enrolled in present ICONICC study 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)
- Household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident or fellow, or optometry student
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Katherine Weise, OD, 205-934-8964, kweise@uab.edu
Katherine Weise, OD, MS
Boston's Children's Hospital
Boston, Massachusetts, 02453
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The Ohio State University College of Optometry
Columbus, Ohio, 43210
Lisa Jones-Jordan, PhD
Lisa Jones-Jordan, PhD
Marshall B. Ketchum University, Southern CA College of Optomwtry
Fullerton, California, 92831
Susan Cotter, OD, MS, 714-463-7575, scotter@ketchum.edu
Angela Chen, OD, MS
New Jersey Institute of Technology
Newark, New Jersey, 07102
Tara Alvarez, PhD
Tara Alvarez, PhD
Stanford University Medical Center
Palo Alto, California, 94304
Gerald Grant, MD
Tawna Roberts, OD, PhD
Salus University/Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19141
About this study
Official title: Interventions for Convergence Insufficiency in Concussed Children (ICONICC)
The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative therapy in children aged 11 to 17 years with symptomatic post-concussion syndrome. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be randomized to a 12-week treatment program of either standard concussion care (SC), SC plus simple convergence procedures (SC+), or SC plus office-based vergence/accommodative therapy SC+OBVAT (1:1:1 ratio).
The study will also compare the effect of treatment on clinical measures of both accommodation and vergence, symptom level/burden, health-related quality of life, clinical measures of saccadic eye movement, and objective eye movement measurements of disparity vergence, saccadic function, and accommodative function. The attainment of objective eye movement measures provides an opportunity to understand the underlying neurophysiology of the vergence and accommodative systems. Objective eye movement recordings are powerful because of the rich foundation from primate single-cell recordings that show a direct correlation with vergence and accommodative parameters in the supraoculomotor area of midbrain2, 3 and the oculomotor vermis of the cerebellum.4, 5 Thus, a combined approach of acquiring both clinical vision function measures and objective eye movement recordings in children with PCS-CI may lead to better characterization of the oculomotor phenotype with subsequent improved and personalized therapeutic interventions.
Read the detailed description
Objectives:
A group of 264 diverse children, ages 11 to 17 years, with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be enrolled from 6 sites from across the United States, will be randomized to 12 weeks of: 1) standard care (SC), 2) SC plus simple convergence exercises (SC+), and 3) SC plus office-based vergence/ accommodative therapy (SC+OBVAT).
Primary Objective: To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of clinical findings (near point of convergence and positive fusional vergence at near) in children 11-17 years of age with concussion-related CI after 12 weeks of treatment.
- Secondary outcome measures
- Objective measures of disparity vergence, accommodation, saccades, and smooth pursuit
- Quality of life measures
- Convergence Insufficiency Symptom Survey Concussion Version (CISS-CON)
- PedsQL Version 4 For participants in any treatment group who not "successful" based on the composite score described above, additional/different treatment will be offered as an option after the primary outcome examination
- Conditions
- Concussion, Convergence Insufficiency
- Being tested
- Standard Community Concussion Care (SC), SC plus Simple Convergence Exercises (SC+), SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)
- Keywords
- convergence insufficiency, concussion, vision therapy, vision rehabilitation
- Medical subject headings
- Brain Concussion, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Community Concussion Care (SC)Behavioural
Also called Concussion treatment
temporary rest, gradual increase in activity, and return to school and sports. In some cases vestibular an balance therapy are necessary, aerobic exercises, medication, counseling.
SC plus Simple Convergence Exercises (SC+)Behavioural
Also called Concussion care plus convergence exercises
In addition to standard community care in this intervention the participants must perform convergence therapy every day at home
SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)Behavioural
Also called vision therapy
In addition to standard community care in this intervention the participants must come to the office once a week for a 1-hour therapy session with a therapist. Office-based vergence/accommodative therapy is performed for 12 weeks with home reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Standard Community Concussion Care (SC) | Active comparator | Standard concussion care consists of physical and cognitive rest immediately following the injury for a brief period of time to allow symptoms to abate, followed by a gradual reintroduction of academic and physical activities, restricting activities at high risk for repeat brain injury (such as contact or collision sports) until a graded return to play protocol has been completed in a symptom-free manner. Receives: Behavioral: Standard Community Concussion Care (SC) |
| SC plus Simple Convergence Procedures (SC+) | Experimental | In addition to the treatment described for SC, participants in this group will be asked to work with the Brock String, which is a popular and simple therapy technique designed to improve convergence. A 3-phase, graded Brock String procedure has been developed for ICONICC. Receives: Behavioral: SC plus Simple Convergence Exercises (SC+) |
| SC plus Office-based Vergence/Accommodative Therapy (SC+VAT) | Experimental | Office-based vergence accommodative therapy (OBVAT) is administered by a study certified therapist at weekly intervals (60-minute office visits with 55 minutes of therapy time), combined with procedures to practice at home for 15 minutes, 5 times per week. Receives: Behavioral: SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Measure of the Near Point of Convergence (NPC) and Positive Fusional Vergence at Near (PFV)
To evaluate successful treatment of CI, we will use a composite outcome classification of the 2 clinical outcome measures of NPC and PFV from baseline to the primary outcome examination. A participant will be defined as successfully treated if both criteria are met: 1) normal NPC (i.e., less than 6 cm) and 2) normal PFV (i.e., greater than 15 prism diopters base-out and passing Sheard's criterion
Measured: 12 weeks
Secondary outcomes (7)
Peak velocity for 4° symmetrical convergence steps
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Peak velocity will be measured with this instrument and a secondary outcome measures will be the change in peak velocity for 4° symmetrical convergence steps
Measured: 12 weeks
Time to peak velocity for 4° symmetrical convergence steps
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be 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: 12 Weeks
Latency for 4° symmetrical convergence steps
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: 12 weeks
Response Amplitude for 4° symmetrical convergence steps
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be 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 response amplitude for 4° symmetrical convergence steps
Measured: 12 weeks
Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON)
The change in the score on this survey will be a secondary outcome assessing symptoms
Measured: 12 weeks
Post-concussion Symptom Inventory (PCSI)
PCSI is a 26-item validated symptom inventory for children with concussion that identifies physical, cognitive, emotional and sleep factors following injury and is useful in capturing and tracking post-injury symptoms through recovery. The change in this score will be used as a secondary outcome measure.
Measured: 12 weeks
PedsQL (Pediatric Quality of Life Inventory)
PedsQL (Pediatric Quality of Life Inventory) measures health-related quality of life (HRQOL) in children and adolescents. The change in this score will be used as a secondary outcome measure.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Apr 2021 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies 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
- Model description
- To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of clinical findings (near point of convergence and positive fusional vergence at near) in children 11-17 years of age with concussion-related CI after 12 weeks of treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitchell Scheiman
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of Alabama at Birmingham, Marshall B. Ketchum University, Stanford University, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Boston Children's Hospital, New Jersey Institute of Technology
- Responsible party
- Sponsor-investigator, Mitchell Scheiman, Salus University
- Investigators
- Mitchell Scheiman, OD, PhD, Study chair, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908112
- Sponsor's protocol ID
- Salus 1003-2019
- Acronym
- ICONICC
- Status last verified
- Oct 2020
- First submitted
- 4 Apr 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A number assigned centrally by the CC will identify all enrolled participants. Participant data will be secured, all clinical sites, the CC, and the Resource Center in a manner to protect participant confidentiality. Only the PI, Clinic Coordinator, and Therapist will have access to the data at the clinical site. Data will be transmitted to the CC via a secure website, with the participant identified by his/her study ID number only. The informed consent document will inform all participants that their data will be sent to the Coordinating Center. Although results of the study will be presented at scientific meetings and reported in medical journals, at no time will any of the study participants be identified. The study will be monitored by the DSMC (see below) to ensure the safety of participants.
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
- Interventions for Convergence Insufficiency in Concussed Children (ICONICC)
- ClinicalTrials.gov ID
- NCT03908112
- Acronym / sponsor ID
- ICONICC / Salus 1003-2019
- Conditions
- Concussion, Convergence Insufficiency
- Keywords
- convergence insufficiency, concussion, vision therapy, vision rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Mitchell ScheimanUniversity, hospital or other
- Collaborators
- Ohio State University, University of Alabama at Birmingham, Marshall B. Ketchum University, Stanford University, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Boston Children's Hospital, New Jersey Institute of Technology
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 Apr 2019 (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.
The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative therapy in children aged 11 to 17 years with symptomatic post-concussion syndrome. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be randomized to a 12-week treatment program of either standard concussion care (SC), SC plus simple convergence procedures (SC+), or SC plus office-based vergence/accommodative therapy SC+OBVAT (1:1:1 ratio).
The study will also compare the effect of treatment on clinical measures of both accommodation and vergence, symptom level/burden, health-related quality of life, clinical measures of saccadic eye movement, and objective eye movement measurements of disparity vergence, saccadic function, and accommodative function. The attainment of objective eye movement measures provides an opportunity to understand the underlying neurophysiology of the vergence and accommodative systems. Objective eye movement recordings are powerful because of the rich foundation from primate single-cell recordings that show a direct correlation with vergence and accommodative parameters in the supraoculomotor area of midbrain2, 3 and the oculomotor vermis of the cerebellum.4, 5 Thus, a combined approach of acquiring both clinical vision function measures and objective eye movement recordings in children with PCS-CI may lead to better characterization of the oculomotor phenotype with subsequent improved and personalized therapeutic interventions.
Detailed description
Objectives:
A group of 264 diverse children, ages 11 to 17 years, with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be enrolled from 6 sites from across the United States, will be randomized to 12 weeks of: 1) standard care (SC), 2) SC plus simple convergence exercises (SC+), and 3) SC plus office-based vergence/ accommodative therapy (SC+OBVAT).
Primary Objective: To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of clinical findings (near point of convergence and positive fusional vergence at near) in children 11-17 years of age with concussion-related CI after 12 weeks of treatment.
- Secondary outcome measures
- Objective measures of disparity vergence, accommodation, saccades, and smooth pursuit
- Quality of life measures
- Convergence Insufficiency Symptom Survey Concussion Version (CISS-CON)
- PedsQL Version 4 For participants in any treatment group who not "successful" based on the composite score described above, additional/different treatment will be offered as an option after the primary outcome examination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of clinical findings (near point of convergence and positive fusional vergence at near) in children 11-17 years of age with concussion-related CI after 12 weeks of treatment.
| Arm | Type | Receives |
|---|---|---|
| Standard Community Concussion Care (SC) | Active comparator | Behavioral: Standard Community Concussion Care (SC)Standard concussion care consists of physical and cognitive rest immediately following the injury for a brief period of time to allow symptoms to abate, followed by a gradual reintroduction of academic and physical activities, restricting activities at high risk for repeat brain injury (such as contact or collision sports) until a graded return to play protocol has been completed in a symptom-free manner. |
| SC plus Simple Convergence Procedures (SC+) | Experimental | Behavioral: SC plus Simple Convergence Exercises (SC+)In addition to the treatment described for SC, participants in this group will be asked to work with the Brock String, which is a popular and simple therapy technique designed to improve convergence. A 3-phase, graded Brock String procedure has been developed for ICONICC. |
| SC plus Office-based Vergence/Accommodative Therapy (SC+VAT) | Experimental | Behavioral: SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)Office-based vergence accommodative therapy (OBVAT) is administered by a study certified therapist at weekly intervals (60-minute office visits with 55 minutes of therapy time), combined with procedures to practice at home for 15 minutes, 5 times per week. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- ICONICC will enroll children of all races and will adhere to a policy of equitability. To be eligible to participate in ICONICC, the child must meet all of the following criteria:
- Medical diagnosis of concussion of at least 4 weeks and no longer than 12 weeks since known date of injury
- Age 11 to 17 years
- Gender - any
- CI Symptom Survey (CISS) score ≥ 16
Key exclusion criteria (13 listed)
- Any strabismus at distance
- Constant strabismus at near
- Limitation on versions/ductions due to restrictive or paretic strabismus
- Esophoria of ≥ 2∆ at distance
- Vertical heterophoria ≥ 2∆ at distance or near
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 |
|---|---|---|
| Standard Community Concussion Care (SC)Also: Concussion treatmenttemporary rest, gradual increase in activity, and return to school and sports. In some cases vestibular an balance therapy are necessary, aerobic exercises, medication, counseling. | Behavioural | Standard Community Concussion Care (SC) |
| SC plus Simple Convergence Exercises (SC+)Also: Concussion care plus convergence exercisesIn addition to standard community care in this intervention the participants must perform convergence therapy every day at home | Behavioural | SC plus Simple Convergence Procedures (SC+) |
| SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)Also: vision therapyIn addition to standard community care in this intervention the participants must come to the office once a week for a 1-hour therapy session with a therapist. Office-based vergence/accommodative therapy is performed for 12 weeks with home reinforcement. | Behavioural | SC plus Office-based Vergence/Accommodative Therapy (SC+VAT) |
Primary outcome
Composite of Measure of the Near Point of Convergence (NPC) and Positive Fusional Vergence at Near (PFV)
Time frame: 12 weeks
To evaluate successful treatment of CI, we will use a composite outcome classification of the 2 clinical outcome measures of NPC and PFV from baseline to the primary outcome examination. A participant will be defined as successfully treated if both criteria are met: 1) normal NPC (i.e., less than 6 cm) and 2) normal PFV (i.e., greater than 15 prism diopters base-out and passing Sheard's criterion
7 secondary outcomes
Peak velocity for 4° symmetrical convergence steps
Time frame: 12 weeks
Time to peak velocity for 4° symmetrical convergence steps
Time frame: 12 Weeks
Latency for 4° symmetrical convergence steps
Time frame: 12 weeks
Response Amplitude for 4° symmetrical convergence steps
Time frame: 12 weeks
Convergence Insufficiency Symptom Survey - Concussion Version (CISS-CON)
Time frame: 12 weeks
Post-concussion Symptom Inventory (PCSI)
Time frame: 12 weeks
PedsQL (Pediatric Quality of Life Inventory)
Time frame: 12 Weeks
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. A number assigned centrally by the CC will identify all enrolled participants. Participant data will be secured, all clinical sites, the CC, and the Resource Center in a manner to protect participant confidentiality. Only the PI, Clinic Coordinator, and Therapist will have access to the data at the clinical site. Data will be transmitted to the CC via a secure website, with the participant identified by his/her study ID number only. The informed consent document will inform all participants that their data will be sent to the Coordinating Center. Although results of the study will be presented at scientific meetings and reported in medical journals, at no time will any of the study participants be identified. The study will be monitored by the DSMC (see below) to ensure the safety of participants.
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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, PhD study chair
Salus 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 Standard Community Concussion Care (SC), SC plus Simple Convergence Exercises (SC+) and SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT) in people with Concussion and Convergence Insufficiency, run by Mitchell Scheiman 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 18 inclusion and 13 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 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. 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?
Contact Mitchell Scheiman, OD, PhD (215-780-1427, mscheiman@salus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Measure of the Near Point of Convergence (NPC) and Positive Fusional Vergence at Near (PFV) (time frame: 12 weeks). 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.