Convergence Insufficiency Treatment Study (CITS)

NCT01515943 | Completed Results DMC

• 2 other identifiers: CITS2U10EY011751
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

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.

Conditions

Convergence Insufficiency

Keywords

Convergence insufficiency

Outcome Measures

Primary Outcomes (2)

• 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: 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

  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: 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

  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

  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

  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

  12 weeks after randomization (baseline)

• Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group

  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

  12 weeks after randomization (baseline)

Study Arms (3)

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.

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.

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.

Other: Placebo home-based computer vergence/accommodative therapy; Procedure: Placebo yoked prism flippers

Interventions

Active home-based computer vergence/accommodative therapy OTHER

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.

Also known as: Home Therapy System (HTS, Home Vision Therapy, Inc.)

Computer-based therapy (CBT)

Near target push-ups PROCEDURE

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.

Also known as: Pencil push-ups

Near target push-up (NTP)

Placebo home-based computer vergence/accommodative therapy OTHER

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.

Also known as: Home Therapy System (HTS, Home Vision Therapy, Inc.)

Near target push-up (NTP); Placebo

Placebo yoked prism flippers PROCEDURE

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

Computer-based therapy (CBT); Placebo

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• ≥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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

Everett & Hurite Ophthalmic Association

Cranberry TWP, Pennsylvania, 16066, United States

Location

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (2)

• 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.

  PMID: 27575992 RESULT

• Scheiman 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.

  PMID: 33263359 DERIVED

MeSH Terms

Conditions

Ocular Motility Disorders

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Differential loss to follow-up (HB-C 8%, HB-PU 19%, and HB-P 30%). Did not formally assess whether participants remained masked to their treatment group during the study. Assessment of compliance was not completely objective.

Results Point of Contact

• Title: Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

813-975-8690

Study Officials

• Mitchell M Scheiman, OD

  Jaeb Center for Health Research

  STUDY CHAIR

• Darren L Hoover, MD

  Jaeb Center for Health Research

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 12, 2017
• Results First Posted: August 5, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)