Convergence InsufficiencyNCT01515943
Convergence Insufficiency Treatment Study (CITS)
A study testing Active home-based computer vergence/accommodative therapy and Near target push-ups in people with Convergence Insufficiency, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of home-based computer therapy for symptomatic convergence insufficiency (CI) compared to traditional home-based near target push-ups and placebo treatment. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Active home-based computer vergence/accommodative therapy and Near target push-ups
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child
Who may be able to join
- Age: 9 to <18 years
- Patient has access to a computer with a CD/DVD drive and internet access for the next 12 weeks
- Best-corrected visual acuity of ≥20/25 in each eye at distance and near
- Exophoria at near at least 4 pd greater than at distance
- Reduced positive fusional convergence at near (<20 pd or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria). PFV is recorded as the prism magnitude where vision is first blurred (or break if no blur is reported).
- Near point of convergence of ≥6 cm break
Show all 21Show fewer
- Randot Preschool stereoacuity of at least 400 seconds of arc
- CI Symptom Survey score ≥16
- No use of a plus add for near or base-in prism for at least 2 weeks preceding enrollment
- Patient must be wearing appropriate refractive correction (spectacle or contact lenses) for at least 2 weeks prior to enrollment if refractive error is present (based on a cycloplegic refraction within the last 6 months) that meets the following:
- Myopia more than -0.75D spherical equivalent (SE) in either eye
- Hyperopia more than +2.00D SE in either eye
- SE anisometropia >1.00D
- Astigmatism > 1.00D or > 1.50D of meridional difference in either eye Refractive correction for patients meeting the above refractive error criteria must meet the following guidelines:
- SE anisometropia must be within 0.25D of the full anisometropic correction.
- Astigmatism cylinder must be within 0.50D of full correction and axis must be within 5 degrees.
- For hyperopia, the spherical component can be reduced by up to 1.50D at investigator discretion provided the reduction is symmetrical and results in residual (i.e., uncorrected) SE hyperopia that does not exceed +2.00D.
- For myopia, the SE must be within 0.25D of the full myopic correction.
- Parent and patient understand the protocol and are willing to accept randomization.
- Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
- Relocation outside of area of an active PEDIG site within the next 15 months is not anticipated.
Who cannot join
- ≥2 logMAR line difference in best-corrected visual acuity between the two eyes
- Constant or intermittent exotropia at distance; constant exotropia at near
- Any esotropia at distance or near
- Distance exophoria > 10 pd
- History of strabismus surgery
- Anisometropia ≥2.00D in any meridian between the eyes
Show all 19Show fewer
- Prior intraocular or refractive surgery
- Primary vertical heterophoria greater than 1 pd
- Diseases known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease
- Current use of any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti- cholinergics (e.g., Motion sickness patch (scopolamine), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
- Near point of accommodation >20 cm in the right eye
- Manifest or latent nystagmus evident clinically
- History of chronic headaches unrelated to reading activity
- Active symptomatic allergic conjunctivitis
- Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis that in the investigator's discretion would interfere with treatment or evaluation
- Household member or sibling already enrolled in the CITS OR previously enrolled in the CITT
- Household member is an eye professional, ophthalmic technician, ophthalmology or optometry resident, orthoptist, or optometry student, or employed in an eye care setting
- Acquired brain injury
- Previous office- or home-based vision therapy, orthoptics, home-based near- target push-ups, pencil push-ups, or home-based computer therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Everett & Hurite Ophthalmic Association
Cranberry TWP, Pennsylvania, 16066
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141
About this study
Official title: Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency
The purpose of this study is to determine the effectiveness of home-based computer therapy for symptomatic convergence insufficiency (CI) compared to traditional home-based near target push-ups and placebo treatment.
Read the detailed description
Convergence insufficiency (CI) is a common and distinct binocular vision disorder that affects approximately 4% of school age children and adults in the United States. Convergence insufficiency is often associated with symptoms such as frequent loss of place while reading, loss of concentration, having to re-read, reading slowly, poor comprehension, sleepiness, blurred vision, diplopia, headaches, and/or eyestrain. A recently completed randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated that a 12-week program of office-based vergence/ accommodative therapy with home reinforcement was more effective than home-based near target pencil push-ups, home-based computer accommodative therapy plus pencil push-ups, or office-based placebo therapy in treating the symptoms and signs associated with symptomatic CI in children 9 to 17 years of age.
While the home-based therapies in the CITT were not as effective as office-based vergence/accommodative therapy there was some improvement noted. Currently, many eye care professionals only offer home-based therapy, while others suggest passive treatment with base-in prism. At a Pediatric Eye Disease Investigator Group (PEDIG) meeting (Tampa, January 2009), the results of a poll of attendees indicated that a large majority of pediatric ophthalmologists continue to recommend home-based near target push-ups as the initial treatment approach for children with symptomatic CI in spite of the CITT results.
There are significant differences in contact time, complexity, and cost between office-based and home-based therapy for CI. Many clinicians believe that the less costly and less complex treatment option should be attempted first. Although home-based therapy using computer software is becoming more popular, no prospective data are available to demonstrate the effectiveness of home-based vision therapy using computer software compared to home-based near target push-ups or home-based placebo computer therapy. A prospective clinical trial is therefore needed to determine the effectiveness of home-based computer therapy for symptomatic CI compared to traditional home-based near target push-ups and placebo treatment.
The current study is a multi-center randomized clinical trial to evaluate the effectiveness of home-based computer vergence/accommodative therapy and home-based near target push-ups in children 9 to <18 years of age with symptomatic CI.
- Conditions
- Convergence Insufficiency
- Being tested
- Active home-based computer vergence/accommodative therapy, Near target push-ups, Placebo home-based computer vergence/accommodative therapy, Placebo yoked prism flippers
- Keywords
- Convergence insufficiency
- 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.
Active home-based computer vergence/accommodative therapyOther
Also called Home Therapy System (HTS, Home Vision Therapy, Inc.)
At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.
Near target push-upsProcedure or surgery
Also called Pencil push-ups
At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the procedures manual for further details.
Placebo home-based computer vergence/accommodative therapyOther
Also called Home Therapy System (HTS, Home Vision Therapy, Inc.)
At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.
Placebo yoked prism flippersProcedure or surgery
Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment phase. This procedure utilizes a 4 pd base right/4 pd base left prism flipper and "Accommodative Hopping Cards". Subjects view the text on the card through the prisms at 40 cm, perform the appropriate task and then flip the prism flipper to the other side after each word before proceeding to the next line. Please refer to the procedures manual for further details. The task remains constant, but the nature of the procedure changes with time:
- Weeks 1-4: View the target through prism flippers
- Weeks 5-8: Wear red-blue filter glasses while viewing the text through prism flippers
- Weeks 9-12: Wear polaroid glasses while viewing the text through prism flippers
| Study group | Role | What they receive |
|---|---|---|
| Computer-based therapy (CBT) | Active comparator | The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. Receives: Other: Active home-based computer vergence/accommodative therapy; Procedure: Placebo yoked prism flippers |
| Near target push-up (NTP) | Active comparator | The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. Receives: Procedure: Near target push-ups; Other: Placebo home-based computer vergence/accommodative therapy |
| Placebo | Placebo comparator | The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. Receives: Other: Placebo home-based computer vergence/accommodative therapy; Procedure: Placebo yoked prism flippers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU
Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%).
Overall success was defined as meeting all of the following criteria at 12 weeks:
- Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
- Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
- Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
Measured: 12 weeks after randomization (baseline)
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P
Pairwise treatment group comparison (HB-C versus Placebo) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons.
Overall success was defined as meeting all of the following criteria at 12 weeks:
- Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks
- Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm
- Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
Measured: 12-weeks after randomization (baseline)
Secondary outcomes (11)
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group
The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 12-week score of <16 points.
Measured: 12 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group
The number of subjects who are classified as a success based on the mean NPC break at the 12-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 12 weeks and a 12-week to baseline ratio of <0.763 for mean NPC break.
Measured: 12 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group
The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 12 weeks and a 12-week to baseline ratio of >1.419 for mean PFV blur.
Measured: 12 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group
The number of subjects classified as a success based on clinical measures of CI (mean NPC break \& mean PFV blur) at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:
- Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm
- Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a 12-week mean PFV blur >15 pd
Measured: 12-weeks after randomization (baseline)
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group
Improvement in all 3 outcome measures at 12 weeks will be defined as follows:
- Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
- Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763
- Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419 (Note: All 3 criteria must be met in order to be classified as an "improver" at the 12-week primary outcome visit).
Measured: 12 weeks after randomization (baseline)
Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks:
- Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks
- Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm
- Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd (Note: All 3 criteria must be met in order to be classified as an overall success at the 6-week visit).
Measured: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group
The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 6-week score of <16 points.
Measured: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group
The number of subjects who are classified as a success based on the mean NPC break at the 6-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 6 weeks and a 6-week to baseline ratio of <0.763 for mean NPC break.
Measured: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group
The number of subjects who are classified as a success based on the mean PFV blur at the 6-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 6 weeks and a 6-week to baseline ratio of >1.419 for mean PFV blur.
Measured: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group
The number of subjects classified as a success based on clinical measures of CI (mean NPC break \& mean PFV blur) at the 6-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:
- Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm
- Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a 6-week mean PFV blur >15 pd
Measured: 6-weeks after randomization (baseline)
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
Improvement in all 3 outcome measures at 6 weeks will be defined as follows:
- Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline
- Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763
- Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 (Note: All 3 criteria must be met in order to be classified as an "improver" at the 6-week visit).
Measured: 6 weeks after randomization (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Mitchell M Scheiman, OD, Study chair, Jaeb Center for Health ResearchDarren L Hoover, MD, Study chair, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515943
- Sponsor's protocol ID
- CITS
- Other IDs
- 2U10EY011751
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2012
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Publications
Pediatric Eye Disease Investigator Group. Home-Based Therapy for Symptomatic Convergence Insufficiency in Children: A Randomized Clinical Trial. Optom Vis Sci. 2016 Dec;93(12):1457-1465. doi: 10.1097/OPX.0000000000000975.
PubMed 27575992Scheiman 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 33263359
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT01515943
- Acronym / sponsor ID
- CITS
- Conditions
- Convergence Insufficiency
- Keywords
- Convergence insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 5 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of home-based computer therapy for symptomatic convergence insufficiency (CI) compared to traditional home-based near target push-ups and placebo treatment.
Detailed description
Convergence insufficiency (CI) is a common and distinct binocular vision disorder that affects approximately 4% of school age children and adults in the United States. Convergence insufficiency is often associated with symptoms such as frequent loss of place while reading, loss of concentration, having to re-read, reading slowly, poor comprehension, sleepiness, blurred vision, diplopia, headaches, and/or eyestrain. A recently completed randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated that a 12-week program of office-based vergence/ accommodative therapy with home reinforcement was more effective than home-based near target pencil push-ups, home-based computer accommodative therapy plus pencil push-ups, or office-based placebo therapy in treating the symptoms and signs associated with symptomatic CI in children 9 to 17 years of age.
While the home-based therapies in the CITT were not as effective as office-based vergence/accommodative therapy there was some improvement noted. Currently, many eye care professionals only offer home-based therapy, while others suggest passive treatment with base-in prism. At a Pediatric Eye Disease Investigator Group (PEDIG) meeting (Tampa, January 2009), the results of a poll of attendees indicated that a large majority of pediatric ophthalmologists continue to recommend home-based near target push-ups as the initial treatment approach for children with symptomatic CI in spite of the CITT results.
There are significant differences in contact time, complexity, and cost between office-based and home-based therapy for CI. Many clinicians believe that the less costly and less complex treatment option should be attempted first. Although home-based therapy using computer software is becoming more popular, no prospective data are available to demonstrate the effectiveness of home-based vision therapy using computer software compared to home-based near target push-ups or home-based placebo computer therapy. A prospective clinical trial is therefore needed to determine the effectiveness of home-based computer therapy for symptomatic CI compared to traditional home-based near target push-ups and placebo treatment.
The current study is a multi-center randomized clinical trial to evaluate the effectiveness of home-based computer vergence/accommodative therapy and home-based near target push-ups in children 9 to <18 years of age with symptomatic CI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computer-based therapy (CBT) | Active comparator | Other: Active home-based computer vergence/accommodative therapy, Procedure: Placebo yoked prism flippersThe CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. |
| Near target push-up (NTP) | Active comparator | Procedure: Near target push-ups, Other: Placebo home-based computer vergence/accommodative therapyThe NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. |
| Placebo | Placebo comparator | Other: Placebo home-based computer vergence/accommodative therapy, Procedure: Placebo yoked prism flippersThe placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- Age: 9 to <18 years
- Patient has access to a computer with a CD/DVD drive and internet access for the next 12 weeks
- Best-corrected visual acuity of ≥20/25 in each eye at distance and near
- Exophoria at near at least 4 pd greater than at distance
- Reduced positive fusional convergence at near (<20 pd or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria). PFV is recorded as the prism magnitude where vision is first blurred (or break if no blur is reported).
Key exclusion criteria (19 listed)
- ≥2 logMAR line difference in best-corrected visual acuity between the two eyes
- Constant or intermittent exotropia at distance; constant exotropia at near
- Any esotropia at distance or near
- Distance exophoria > 10 pd
- History of strabismus surgery
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 |
|---|---|---|
| Active home-based computer vergence/accommodative therapyAlso: Home Therapy System (HTS, Home Vision Therapy, Inc.)At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details. | Other | Computer-based therapy (CBT) |
| Near target push-upsAlso: Pencil push-upsAt enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the procedures manual for further details. | Procedure or surgery | Near target push-up (NTP) |
| Placebo home-based computer vergence/accommodative therapyAlso: Home Therapy System (HTS, Home Vision Therapy, Inc.)At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details. | Other | Near target push-up (NTP), Placebo |
| Placebo yoked prism flippersSubjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment phase. This procedure utilizes a 4 pd base right/4 pd base left prism flipper and "Accommodative Hopping Cards". Subjects view the text on the card through the prisms at 40 cm, perform the appropriate task and then flip the prism flipper to the other side after each word before proceeding to the next line. Please refer to the procedures manual for further details. The task remains constant, but the nature of the procedure changes with time: * Weeks 1-4: View the target through prism flippers * Weeks 5-8: Wear red-blue filter glasses while viewing the text through prism flippers * Weeks 9-12: Wear polaroid glasses while viewing the text through prism flippers | Procedure or surgery | Computer-based therapy (CBT), Placebo |
Primary outcome
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU
Time frame: 12 weeks after randomization (baseline)
Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%). Overall success was defined as meeting all of the following criteria at 12 weeks: 1. Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks 2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm 3. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P
Time frame: 12-weeks after randomization (baseline)
Pairwise treatment group comparison (HB-C versus Placebo) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons. Overall success was defined as meeting all of the following criteria at 12 weeks: 1. Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks 2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm 3. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd
11 secondary outcomes
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group
Time frame: 12 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group
Time frame: 12 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group
Time frame: 12 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group
Time frame: 12-weeks after randomization (baseline)
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group
Time frame: 12 weeks after randomization (baseline)
Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
Time frame: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group
Time frame: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group
Time frame: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group
Time frame: 6 weeks after randomization (baseline)
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group
Time frame: 6-weeks after randomization (baseline)
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
Time frame: 6 weeks after randomization (baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27575992Pediatric Eye Disease Investigator Group. Home-Based Therapy for Symptomatic Convergence Insufficiency in Children: A Randomized Clinical Trial. Optom Vis Sci. 2016 Dec;93(12):1457-1465. doi: 10.1097/OPX.0000000000000975.
- 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.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
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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 M Scheiman, OD study chair
Jaeb Center for Health Research
Darren L Hoover, MD study chair
Jaeb Center for Health Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active home-based computer vergence/accommodative therapy and Near target push-ups in people with Convergence Insufficiency, run by Jaeb Center for Health Research at 2 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 21 inclusion and 19 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU (time frame: 12 weeks after randomization (baseline)). The study lists 2 primary outcomes in all. 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 NCT01515943, which also lists 2 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 12 Apr 2017.