Convergence Insufficiency Treatment Study (CITS)

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

Interventions

OTHER

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.

PROCEDURE

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 procedures manual for further details.

OTHER

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.

PROCEDURE

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 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

Sponsors & Collaborators

• Pediatric Eye Disease Investigator Group

  collaborator NETWORK

• National Eye Institute (NEI)

  collaborator NIH

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Mitchell M Scheiman, OD · Jaeb Center for Health Research

• Darren L Hoover, MD · Jaeb Center for Health Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

9 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations