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Convergence Insufficiency Treatment Study (CITS)

This study has been completed.
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT01515943
First received: January 19, 2012
Last updated: April 11, 2017
Last verified: April 2017
Results First Received: May 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Convergence Insufficiency
Interventions: Other: Active home-based computer vergence/accommodative therapy
Procedure: Near target push-ups
Other: Placebo home-based computer vergence/accommodative therapy
Procedure: Placebo yoked prism flippers

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Computer-based Therapy (CBT)

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.

Active home-based computer vergence/accommodative therapy: 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.

Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment

Near Target Push-up (NTP)

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.

Near target 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.

Placebo

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.

Placebo home-based computer vergence/accommodative therapy: 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 flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5


Participant Flow:   Overall Study
    Computer-based Therapy (CBT)   Near Target Push-up (NTP)   Placebo
STARTED   75   85   44 
COMPLETED   69   69   31 
NOT COMPLETED   6   16   13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Computer-based Therapy (CBT)

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.

Active home-based computer vergence/accommodative therapy: 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.

Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment

Near Target Push-up (NTP)

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.

Near target 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 pr

Placebo

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.

Placebo home-based computer vergence/accommodative therapy: 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 flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5

Total Total of all reporting groups

Baseline Measures
   Computer-based Therapy (CBT)   Near Target Push-up (NTP)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   85   44   204 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      75 100.0%      85 100.0%      44 100.0%      204 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.2  (2.4)   12.6  (2.5)   12.3  (2.3)   12.4  (2.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      46  61.3%      46  54.1%      26  59.1%      118  57.8% 
Male      29  38.7%      39  45.9%      18  40.9%      86  42.2% 
Region of Enrollment 
[Units: Participants]
       
United States   75   85   44   204 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   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) ]

13.  Secondary:   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) ]

14.  Post-Hoc:   Number of Participants Classified as an Overall Success at 12 Weeks in the HB-C Group According to Whether or Not the Computer-based Therapy Program Was Completed at 12 Weeks   [ Time Frame: 12 weeks after randomization (baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: rkraker@jaeb.org


Publications of Results:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01515943     History of Changes
Other Study ID Numbers: CITS
2U10EY011751 ( US NIH Grant/Contract Award Number )
Study First Received: January 19, 2012
Results First Received: May 2, 2016
Last Updated: April 11, 2017