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N/A N=204 Randomized Triple-blind Treatment

Convergence Insufficiency Treatment Study (CITS)

Convergence Insufficiency

Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU — 16; 15; 5 Participants — p=0.56

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Active home-based computer vergence/accommodative therapy (Other); Near target push-ups (Procedure); Placebo home-based computer vergence/accommodative therapy (Other); Placebo yoked prism flippers (Procedure)
Age
Pediatric · 9+ yrs
Sex
All
Sponsor
Jaeb Center for Health Research
Primary completion
Jan 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU
16; 15; 5 0.56
PRIMARY
Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P
16; 15; 5 0.52
SECONDARY
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group
28; 25; 11
SECONDARY
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group
33; 33; 11
SECONDARY
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group
49; 35; 16
SECONDARY
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group
30; 22; 9
SECONDARY
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group
27; 25; 10
SECONDARY
Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
5; 2; 1
SECONDARY
Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group
13; 8; 8
SECONDARY
Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group
24; 20; 5
SECONDARY
Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group
38; 23; 12
SECONDARY
Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group
20; 10; 3
SECONDARY
Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group
17; 13; 3

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.

Eligibility Criteria

Inclusion Criteria

  • Age: 9 to 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01515943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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