Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia

NCT ID: NCT00587171

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-10-31

Brief Summary

This study is comparing the effectiveness of patching combined with active vision therapy plus near activities versus patching combined with control vision therapy plus near activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds.

The primary outcome measure is the proportion of patients with visual acuity of 20/25 or better in the amblyopic eye at the 17-week masked exam. These patients will be considered treatment responders. The primary analysis will consist of a comparison between the 2 treatment groups of the proportion of treatment responders with adjustment for baseline visual acuity.

Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual acuity at the 17-week masked exam, and rate of improvement of visual acuity.

Detailed Description

Patching and atropine have been traditionally used for the improvement of visual acuity in children with amblyopia. Previous studies have shown that these methods of treatment are effective in young children with functional amblyopia. More recently ATS3, a randomized clinical trial of 507 children ages 7-<18, found that part-time patching combined with atropine and near activities improved visual acuity by two or more lines in 53% of the 7 to 12 year olds compared to 25% for optical correction alone. For the 13 to 17 year olds, part-time patching and near activities improved visual acuity by 2 or more lines in 25%, compared to 23% for optical correction alone. While it appears that patching and/or atropine, combined with near activities, can improve visual acuity in some patients ages 7-<18, most patients in the study were left with residual visual acuity deficits. To further improve visual acuity and binocularity in children with amblyopia some eye care providers augment these traditional therapies with vision therapy. Vision therapy is prescribed initially if there is moderate amblyopia with stereopsis. Vision therapy can be added to the treatment regimen once the patient has reached moderate levels of vision loss with stereopsis and if the patient is still not responding to the current treatment and still has moderate amblyopia. It is thought that the best candidates for this type of therapy are those children with a minimum level of stereopsis (at least 800") and without constant strabismus. Those children with no stereopsis would not be able to perform the activities in the later stages of therapy utilizing binocular vision.

Vision therapy is a sequence of prescribed activities typically performed on a daily basis at home and weekly in-office, and is directed toward an individual patient's deficient skills. Visual skills are practiced under conditions that provide the patient with feedback. The feedback, along with a gradual increase in the demand of the activities as improvement occurs, enables the patient to improve visual functions such as visual acuity, fixation, accommodation, and vergence skills.

There have been case reports and small sample studies that have shown that vision therapy in combination with spectacles and occlusion is effective in improving the visual acuity of patients with amblyopia. Wick et al looked at nineteen patients who were diagnosed with anisometropic amblyopia between the ages of 6 to 49. Seventeen of the patients had moderate amblyopia and two had severe amblyopia, based on the definition of amblyopia used in the Amblyopia Treatment Studies. The patients were treated with a sequence that included spectacle correction, occlusion therapy and both monocular and binocular vision therapy. Thirteen of the seventeen patients with moderate amblyopia had a final visual acuity of 20/25 or better and all of the patients with moderate amblyopia had 20/30 or better final visual acuity.

More recent reports on "perceptual learning," an active form of therapy in which amblyopic subjects practice a position-discrimination task, have shown a mean acuity improvement of approximately 30% (two lines) in amblyopic children and adults who had completed occlusion therapy. These studies provide support for the notion that the practice of particular visual skills under conditions that provide the patient with feedback (e.g., vision therapy) may be beneficial in improving the visual performance of amblyopic eyes.

The second reason to prescribe active therapy is to enhance or facilitate the effects of occlusion by directly treating the aforementioned deficits found to be associated with amblyopia. Most therapy procedures are designed to remediate specific deficiencies in four main areas: fixation, spatial perception, accommodative efficiency, binocular function and oculomotor control.

Lastly, some investigators have suggested that the use of vision therapy may reduce the likelihood of recurrence of the amblyopia. This may be particularly true with anisometropic amblyopia in which vision therapy can be used to improve binocular function.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy

Group Type: ACTIVE_COMPARATOR

Patching

Intervention Type: DEVICE

2 hours daily patching

Near activities

Intervention Type: PROCEDURE

30 minutes daily near activities at home

Active vision therapy

Intervention Type: PROCEDURE

30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session

Control

2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy

Group Type: SHAM_COMPARATOR

Patching

Intervention Type: DEVICE

2 hours daily patching

Near activities

Intervention Type: PROCEDURE

30 minutes daily near activities at home

Control vision therapy

Intervention Type: PROCEDURE

30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session

Interventions

Patching

2 hours daily patching

Intervention Type: DEVICE

Near activities

30 minutes daily near activities at home

Intervention Type: PROCEDURE

Active vision therapy

30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session

Intervention Type: PROCEDURE

Control vision therapy

30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session

Intervention Type: PROCEDURE

Other Intervention Names

Coverlet, 3M Opticlude, Ortopad®

Eligibility Criteria

Inclusion Criteria

• Age 7 to <13 years
• Amblyopia associated with anisometropia, strabismus (comitant or incomitant), or both at the time of the eligibility examination
• Visual acuity in the amblyopic eye between 49 and 71 letters inclusive (20/40 to 20/100 inclusive) on the eETDRS
• Visual acuity in the sound eye of 79 or more letters on the eETDRS (20/25 or better)
• Inter-eye acuity difference of 15 or more letters (3 or more logMAR lines)
• At least 800 seconds of arc on the Randot Preschool Stereoacuity Test
• Previous or current amblyopia treatment with spectacles or contact lenses, patching or atropine is permitted.
• No myopia more than -6.00 D spherical equivalent in the amblyopic eye
• Single vision spectacles, if needed, worn for at least 16 weeks or until visual acuity documented to be stable
• The child has access to a computer on a daily basis (to use the home vision therapy software)

Exclusion Criteria

• Previous vision therapy or orthoptics
• Known skin reactions to patch or bandage adhesives
• Prior intraocular or refractive surgery
• Bifocals
• Constant strabismus at near at the eligibility examination
• A family member is (or has been) enrolled in this study

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Ray Kraker

Director, PEDIG Coordinating Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Don W. Lyon, O.D.

Role: STUDY_CHAIR

Indiana University

David T. Wheeler, M.D.

Role: STUDY_CHAIR

Casey Eye Institute

Locations

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Indiana University School of Optometry

Bloomington, Indiana, United States

Casey Eye Institute

Portland, Oregon, United States

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, United States

Family Eye Group

Lancaster, Pennsylvania, United States

Southern College of Optometry

Memphis, Tennessee, United States

Countries

United States

References

Lyon DW, Hopkins K, Chu RH, Tamkins SM, Cotter SA, Melia BM, Holmes JM, Repka MX, Wheeler DT, Sala NA, Dumas J, Silbert DI; Pediatric Eye Disease Investigator Group. Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optom Vis Sci. 2013 May;90(5):475-81. doi: 10.1097/OPX.0b013e31828def04.

Reference Type: RESULT

PMID: 23563444 (View on PubMed)

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NEI-138

Identifier Type: -

Identifier Source: org_study_id