Convergence InsufficiencyNCT03593031
Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
A study testing Office Based Vergence and Accommodative Therapy in people with Convergence Insufficiency, run by New Jersey Institute of Technology at 1 site in United States.
Trial summary
Convergence insufficiency (CI) is a prevalent binocular vision disorder with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work. CI is present in 4% of the population where approximately 27% of CI patients do not improve even with validated therapy. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Office Based Vergence and Accommodative Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 1 Jan 2020
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of symptomatic convergence insufficiency binocularly normal control
Who cannot join
- history of head trauma any systematic disease that can interfere with vergence or accommodation such as multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
Convergence insufficiency (CI) is a prevalent binocular vision disorder with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work. CI is present in 4% of the population where approximately 27% of CI patients do not improve even with validated therapy. The project will quantitatively study changes in convergence eye movements and neural substrates before and after validated therapy in CI patients. This knowledge can lead to improvements in currently validated therapy, reduction in therapy sessions, and reduced healthcare costs.
Read the detailed description
Convergence insufficiency (CI), a prevalent binocular vision disorder in adults and children, is characterized by greater exophoria at near than at distance, reduced fusional convergence amplitude, receded near point of convergence, and a reduced accommodative convergence over accommodation ratio (AC/A). CI is associated with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work, thus interfering with activities of daily living. The recent NEI/NIH multi-center randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated the effectiveness of Office-Based Vergence and Accommodative Therapy with home reinforcement (OBVAT) for CI, reporting 73% of patients have sustained improvements of vision function and symptoms. The team published the first fMRI neural substrate data evoked using convergence eye movements in CI patients before and then post-OBVAT. The team's results suggest that with the reduction of visual symptoms, the following were observed: 1) an increase in the percent signal change of functional activity in the frontal eye fields, posterior parietal cortex and the cerebellar vermis, 2) an increase in convergence peak velocity, 3) a decrease in the near point of convergence, 4) an increase in positive fusional amplitude and 5) a reduction in the amount of exophoria at near. The aims of the current proposal are to test the following two hypotheses as potential underlying mechanisms of CI that may be improved post OBVAT: 1) a reduced ability to adapt vergence in near and far space via the 'slow' component of vergence and 2) a reduced ability to quickly diminish disparity error via the 'fast' component of vergence. Not only will our quantitative methods integrated with established CITT standards address important questions about potential mechanisms causing CI, this proposal seeks to identify how a validated vergence therapy may remediate symptoms. This proposal will determine whether either of these two potential mechanisms are causing CI by quantifying the following: 1) rate and magnitude of phoria adaptation, 2) forced vergence fixation disparity curves, 3) peak velocity of convergence eye movements (studying visual cues such as disparity, accommodation and proximal stimuli in isolation and combination), and 4) the functional activity of the fast and slow vergence neural substrates prior to, and then after, OBVAT. The assembled study team is particularly knowledgeable in terms of OBVAT, convergence insufficiency, optometry, vision science, oculomotor research, functional imaging, modeling and statistics with the necessary resources to successfully complete both aims of this study. Results from the project's aims can lead to targeted treatments with improved success rates, potentially reducing the time to remediate symptoms, and ultimately reducing health care costs.
- Conditions
- Convergence Insufficiency
- Being tested
- Office Based Vergence and 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 and Accommodative TherapyBehavioural
Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.
| Study group | Role | What they receive |
|---|---|---|
| CI OBVAT | Active comparator | Patients with Convergence Insufficiency in Active Vision Therapy Receives: Behavioral: Office Based Vergence and Accommodative Therapy |
| CI Sham therapy | Sham comparator | CI Sham therapy Receives: Behavioral: Office Based Vergence and Accommodative Therapy |
| Controls OBVAT | Active comparator | Control receive active therapy Receives: Behavioral: Office Based Vergence and Accommodative Therapy |
| Controls Sham | Sham comparator | Subjects with Normal Binocular Vision will receive a therapy that appears to be therapeutic but does not have any binocular coordination benefits. Receives: Behavioral: Office Based Vergence and Accommodative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disparity Vergence Response Amplitude
how accurate a patient can fixate on a new target
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Apr 2014
- Primary completion1 Apr 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Jersey Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Dr. Tara Lynn Alvarez, New Jersey Institute of Technology
- Investigators
- Atam Dhawan, PhD, Study director, New Jersey Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593031
- Sponsor's protocol ID
- F182-13
- Other IDs
- R01EY023261
- Status last verified
- Feb 2020
- First submitted
- 6 Jul 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan in place because the eye movement data collected will be in a proprietary format
Publications
Fine SN, Rutkowski T, Santos EM, Gohel S, Hajebrahimi F, Scheiman M, Alvarez TL. Heath components of objective accommodative responses for convergence insufficiency participants compared with those with binocularly normal vision. Optom Vis Sci. 2025 Dec 1;102(12):731-742. doi: 10.1097/OPX.0000000000002307. Epub 2025 Nov 18.
PubMed 41252526Hajebrahimi F, Sangoi A, Scheiman M, Santos E, Gohel S, Alvarez TL. From convergence insufficiency to functional reorganization: A longitudinal randomized controlled trial of treatment-induced connectivity plasticity. CNS Neurosci Ther. 2024 Aug;30(8):e70007. doi: 10.1111/cns.70007.
PubMed 39185637Hajebrahimi F, Gohel S, Scheiman M, Sangoi A, Iring-Sanchez S, Morales C, Santos EM, Alvarez TL. Altered Large-Scale Resting-State Functional Network Connectivity in Convergence Insufficiency Young Adults Compared With Binocularly Normal Controls. Invest Ophthalmol Vis Sci. 2023 Nov 1;64(14):29. doi: 10.1167/iovs.64.14.29.
PubMed 37982763Alvarez TL, Scheiman M, Morales C, Gohel S, Sangoi A, Santos EM, Yaramothu C, d'Antonio-Bertagnolli JV, Li X, Biswal BB. Underlying neurological mechanisms associated with symptomatic convergence insufficiency. Sci Rep. 2021 Mar 22;11(1):6545. doi: 10.1038/s41598-021-86171-9.
PubMed 33753864Alvarez TL, Scheiman M, Santos EM, Morales C, Yaramothu C, D'Antonio-Bertagnolli JV, Biswal BB, Gohel S, Li X. The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data. Ophthalmic Epidemiol. 2020 Feb;27(1):52-72. doi: 10.1080/09286586.2019.1679192. Epub 2019 Oct 22.
PubMed 31640452
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT03593031
- Acronym / sponsor ID
- F182-13
- Conditions
- Convergence Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- New Jersey Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 19 Jul 2018 (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.
Convergence insufficiency (CI) is a prevalent binocular vision disorder with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work. CI is present in 4% of the population where approximately 27% of CI patients do not improve even with validated therapy. The project will quantitatively study changes in convergence eye movements and neural substrates before and after validated therapy in CI patients. This knowledge can lead to improvements in currently validated therapy, reduction in therapy sessions, and reduced healthcare costs.
Detailed description
Convergence insufficiency (CI), a prevalent binocular vision disorder in adults and children, is characterized by greater exophoria at near than at distance, reduced fusional convergence amplitude, receded near point of convergence, and a reduced accommodative convergence over accommodation ratio (AC/A). CI is associated with symptoms that include double/blurred vision, eyestrain, and headaches when engaged in reading or other near work, thus interfering with activities of daily living. The recent NEI/NIH multi-center randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated the effectiveness of Office-Based Vergence and Accommodative Therapy with home reinforcement (OBVAT) for CI, reporting 73% of patients have sustained improvements of vision function and symptoms. The team published the first fMRI neural substrate data evoked using convergence eye movements in CI patients before and then post-OBVAT. The team's results suggest that with the reduction of visual symptoms, the following were observed: 1) an increase in the percent signal change of functional activity in the frontal eye fields, posterior parietal cortex and the cerebellar vermis, 2) an increase in convergence peak velocity, 3) a decrease in the near point of convergence, 4) an increase in positive fusional amplitude and 5) a reduction in the amount of exophoria at near. The aims of the current proposal are to test the following two hypotheses as potential underlying mechanisms of CI that may be improved post OBVAT: 1) a reduced ability to adapt vergence in near and far space via the 'slow' component of vergence and 2) a reduced ability to quickly diminish disparity error via the 'fast' component of vergence. Not only will our quantitative methods integrated with established CITT standards address important questions about potential mechanisms causing CI, this proposal seeks to identify how a validated vergence therapy may remediate symptoms. This proposal will determine whether either of these two potential mechanisms are causing CI by quantifying the following: 1) rate and magnitude of phoria adaptation, 2) forced vergence fixation disparity curves, 3) peak velocity of convergence eye movements (studying visual cues such as disparity, accommodation and proximal stimuli in isolation and combination), and 4) the functional activity of the fast and slow vergence neural substrates prior to, and then after, OBVAT. The assembled study team is particularly knowledgeable in terms of OBVAT, convergence insufficiency, optometry, vision science, oculomotor research, functional imaging, modeling and statistics with the necessary resources to successfully complete both aims of this study. Results from the project's aims can lead to targeted treatments with improved success rates, potentially reducing the time to remediate symptoms, and ultimately reducing health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CI OBVAT | Active comparator | Behavioral: Office Based Vergence and Accommodative TherapyPatients with Convergence Insufficiency in Active Vision Therapy |
| CI Sham therapy | Sham comparator | Behavioral: Office Based Vergence and Accommodative TherapyCI Sham therapy |
| Controls OBVAT | Active comparator | Behavioral: Office Based Vergence and Accommodative TherapyControl receive active therapy |
| Controls Sham | Sham comparator | Behavioral: Office Based Vergence and Accommodative TherapySubjects with Normal Binocular Vision will receive a therapy that appears to be therapeutic but does not have any binocular coordination benefits. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosis of symptomatic convergence insufficiency binocularly normal control
Key exclusion criteria (1 listed)
- history of head trauma any systematic disease that can interfere with vergence or accommodation such as multiple sclerosis
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 and Accommodative TherapyExercises that will stimulate disparity vergence or accommodation independently and then combined will be used. | Behavioural | CI OBVAT, CI Sham therapy, Controls OBVAT, Controls Sham |
Primary outcome
Disparity Vergence Response Amplitude
Time frame: through study completion, an average of 1 year
how accurate a patient can fixate on a new target
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 41252526Fine SN, Rutkowski T, Santos EM, Gohel S, Hajebrahimi F, Scheiman M, Alvarez TL. Heath components of objective accommodative responses for convergence insufficiency participants compared with those with binocularly normal vision. Optom Vis Sci. 2025 Dec 1;102(12):731-742. doi: 10.1097/OPX.0000000000002307. Epub 2025 Nov 18.
- Derived from this study: PubMed 39185637Hajebrahimi F, Sangoi A, Scheiman M, Santos E, Gohel S, Alvarez TL. From convergence insufficiency to functional reorganization: A longitudinal randomized controlled trial of treatment-induced connectivity plasticity. CNS Neurosci Ther. 2024 Aug;30(8):e70007. doi: 10.1111/cns.70007.
- Derived from this study: PubMed 37982763Hajebrahimi F, Gohel S, Scheiman M, Sangoi A, Iring-Sanchez S, Morales C, Santos EM, Alvarez TL. Altered Large-Scale Resting-State Functional Network Connectivity in Convergence Insufficiency Young Adults Compared With Binocularly Normal Controls. Invest Ophthalmol Vis Sci. 2023 Nov 1;64(14):29. doi: 10.1167/iovs.64.14.29.
- Derived from this study: PubMed 33753864Alvarez TL, Scheiman M, Morales C, Gohel S, Sangoi A, Santos EM, Yaramothu C, d'Antonio-Bertagnolli JV, Li X, Biswal BB. Underlying neurological mechanisms associated with symptomatic convergence insufficiency. Sci Rep. 2021 Mar 22;11(1):6545. doi: 10.1038/s41598-021-86171-9.
- Derived from this study: PubMed 31640452Alvarez TL, Scheiman M, Santos EM, Morales C, Yaramothu C, D'Antonio-Bertagnolli JV, Biswal BB, Gohel S, Li X. The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data. Ophthalmic Epidemiol. 2020 Feb;27(1):52-72. doi: 10.1080/09286586.2019.1679192. Epub 2019 Oct 22.
- Individual participant dataSharing planned: No. At this time there is no plan in place because the eye movement data collected will be in a proprietary format
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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.
Atam Dhawan, PhD study director
New Jersey Institute of Technology
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 and Accommodative Therapy in people with Convergence Insufficiency, run by New Jersey Institute of Technology 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Feb 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. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disparity Vergence Response Amplitude (time frame: through study completion, an average of 1 year). 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 NCT03593031, which also lists 5 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 25 Feb 2020.