Convergence Insufficiency Treatment Study (CITS)

Not Applicable

Completed

Conditions: Convergence Insufficiency

Registration Number: NCT01515943

Lead Sponsor: Jaeb Center for Health Research

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 204

Inclusion Criteria

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
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.

Exclusion Criteria

≥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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU	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	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group	12 weeks after randomization (baseline)	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.
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group	12 weeks after randomization (baseline)	Improvement in all 3 outcome measures at 12 weeks will be defined as follows: 1. Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline 2. Near point of convergence (NPC) break: 12-week/baseline mean NPC break \<0.763 3. 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).
Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group	6 weeks after randomization (baseline)	To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks: 1. Convergence Insufficiency Symptom Survey (CISS): 6-week score \<16 points and at least 9-point improvement from baseline at 6 weeks 2. Near point of convergence (NPC) break: 6-week/baseline mean NPC break \<0.763 and a mean 6-week NPC break \<6 cm 3. 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).
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group	12 weeks after randomization (baseline)	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.
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group	12 weeks after randomization (baseline)	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.
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group	12-weeks after randomization (baseline)	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: 1. Near point of convergence (NPC) break: 12-week/baseline mean NPC break \<0.763 and a 12-week mean NPC break \<6 cm 2. Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur \>1.419 and a 12-week mean PFV blur \>15 pd
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group	6 weeks after randomization (baseline)	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.
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group	6-weeks after randomization (baseline)	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: 1. Near point of convergence (NPC) break: 6-week/baseline mean NPC break \<0.763 and a 6-week mean NPC break \<6 cm 2. Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur \>1.419 and a 6-week mean PFV blur \>15 pd
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group	6 weeks after randomization (baseline)	Improvement in all 3 outcome measures at 6 weeks will be defined as follows: 1. Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline 2. Near point of convergence (NPC) break: 6-week/baseline mean NPC break \<0.763 3. 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).
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group	6 weeks after randomization (baseline)	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.
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group	6 weeks after randomization (baseline)	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.

Trial Locations

Locations (2): Everett & Hurite Ophthalmic Association
🇺🇸
Cranberry TWP, Pennsylvania, United States
Pennsylvania College of Optometry
🇺🇸
Philadelphia, Pennsylvania, United States
Everett & Hurite Ophthalmic Association
🇺🇸Cranberry TWP, Pennsylvania, United States