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AmblyopiaPhase 3ATS12NCT00587171

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

A Phase 3 study testing Patching, Near activities and Active vision therapy in people with Amblyopia, run by Jaeb Center for Health Research at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Amblyopia
What is being tested?
Patching, Near activities and Active vision therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
7 sitesUnited States
Study dates
Apr 2008to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • UAB Pediatric Eye Care; Birmingham Health Care

    Birmingham, Alabama, 35294

  • Indiana University School of Optometry

    Bloomington, Indiana, 47405

  • Pediatric Ophthalmology of Erie

    Erie, Pennsylvania, 16501

  • Family Eye Group

    Lancaster, Pennsylvania, 17601

  • Southern College of Optometry

    Memphis, Tennessee, 38104

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Casey Eye Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Randomized Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia in Children 7 to <13 Years Old

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.

Read the 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
Being tested
Patching, Near activities, Active vision therapy, Control vision therapy
Keywords
Amblyopia, Vision Therapy, Patching
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PatchingDevice

    Also called Coverlet, 3M Opticlude, Ortopad®

    2 hours daily patching

  • Near activitiesProcedure or surgery

    30 minutes daily near activities at home

  • Active vision therapyProcedure or surgery

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

  • Control vision therapyProcedure or surgery

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

Study groups in NCT00587171
Study groupRoleWhat they receive
ActiveActive comparator2 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
Receives: Device: Patching; Procedure: Near activities; Procedure: Active vision therapy
ControlSham comparator2 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
Receives: Device: Patching; Procedure: Near activities; Procedure: Control vision therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

    Measured: 17 weeks

  2. Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

    Measured: 17 weeks

  3. Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Measured: Baseline to 17 weeks

  4. Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Measured: Baseline to 17 weeks

Secondary outcomes (8)
  1. Distribution of Fellow Eye Visual Acuity at 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

    Measured: 17 weeks

  2. Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

    Measured: 17 weeks

  3. Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Measured: Baseline to 17 weeks

  4. Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Measured: Baseline to 17 weeks

  5. Mean (SD) of Intereye Visual Acuity at 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

    Measured: 17 weeks

  6. Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks

    Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.

    Measured: Baseline to 17 weeks

  7. Distribution of Randot Preschool Stereoacuity at 17 Weeks

    The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.

    Measured: 17 weeks

  8. Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks

    The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.

    Measured: Baseline to 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMar 2009
  4. Study completionOct 2009

Why it stopped: This study was stopped due to insufficient recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00587171
Sponsor's protocol ID
NEI-138
Other IDs
2U10EY011751
Acronym
ATS12
Status last verified
Jul 2016
First submitted
10 Dec 2007
Last updated
13 Jul 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23563444

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Patching, Near activities and Active vision therapy in people with Amblyopia, run by Jaeb Center for Health Research at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome (time frame: 17 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00587171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.

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