Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

2014-08-27 03:45:10 | BioPortfolio


The purpose of this study is:

- To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.

- To determine the maximum improvement in vision of the amblyopic eye with each treatment.

- To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.


Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have believed that a treatment response is unlikely after the age of 6 or 7 years, while others have considered age 9 or 10 years to be the upper age limit for successful treatment. The American Academy of Ophthalmology Preferred Practice Pattern for amblyopia recommends treatment up to age 10 years. The opinion that amblyopia treatment is ineffective in older children may have arisen because the age of 6 to 7 years is thought to be the end of the "critical period" for visual development in humans. This belief, however, was not based on adequate prospectively-collected data.

To address this issue of the response of amblyopia to treatment in children 7 years and older, the Pediatric Eye Disease Investigator Group (PEDIG) conducted a randomized trial of 507 patients (aged 7 to <18 years) with amblyopic eye visual acuity ranging from 20/40 to 20/400. Patients were provided with optimal optical correction and then randomized to a Treatment Group (2 to 6 hours per day of prescribed patching of the sound eye combined with near visual activities for all patients plus atropine one drop per day in the sound eye for 7 to <13 year olds) or an Optical Correction Group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (2 lines) by 24 weeks were considered responders. In the 7 to <13 year olds (N=404), 53% of the Treatment Group were responders compared with 25% of the Optical Correction Group (P<0.001). In the 13 to <18 year olds (N=103), the responder rates were 25% and 23% respectively overall (adjusted P=0.22), but 47% and 20% respectively among patients not previously treated with patching and/or atropine for amblyopia (adjusted P=0.03). Most patients, including responders, were left with a residual visual acuity deficit.

The use of multiple modalities (patching, atropine, near visual activities) in the treatment regimen for the 7 to <13 year olds in this trial (ATS3) was an effort to maximize the therapeutic response. Patients age 13 years and older were prescribed patching but not atropine because of concern that the continual optical blur from the atropine could have a deleterious effect on their ability to drive and perform other activities. Prescribed patching was 2 to 6 hours a day to limit patch wear to non-school hours and because our prior studies of 3 to <7 year olds demonstrated that as little as two hours of patching a day (when combined with near visual activities) is as effective as a greater number of hours. Instructing patients to perform at least one hour of near activities while wearing the patch was based on the unproven clinical opinion that near activities can augment the effect of the occlusion therapy. A PEDIG pilot study suggested that near activities are beneficial and this question of benefit of near activities is currently being studied in another randomized clinical trial. Atropine placed in the sound eye once a day and two days a week has been demonstrated in younger children to be beneficial to the acuity of the amblyopic eye, presumably due to its cycloplegic effect of blurring vision in the sound eye especially at near fixation. In a study comparing daily and weekend atropine, daily atropine was not found to be superior.

The unanswered question from this completed clinical trial is whether prescribing patching or atropine alone could have produced a response similar to the combination therapy, or whether in this age group, one treatment is better than the other. A poll of PEDIG investigators at an investigator meeting on January 15, 2005 indicated that very few are following the treatment regimen used in the prior study (ATS3); rather, most are prescribing monotherapy—either patching or atropine—as the initial treatment for amblyopia in the 7 to <13 year age range. Thus, a trial comparing atropine and patching as amblyopia treatments in 7 to <13 year olds is needed.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes are: 1) Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day without the aid of reading glasses (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) and 2) Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and > 4 hours per day for severe amblyopes at 5 weeks if acuity not improved by at least 5 letters).

Optional Ancillary Study As part of the optic nerve imaging ancillary study, retinal nerve fiber layer imaging using optical coherence tomography will be performed on some patients. This will be optional for patients at participating sites. The procedure is not part of standard care. The subject's pupils will need to be dilated, if not already dilated as part of the exam. Testing of both eyes can be completed in about 15 minutes.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment




Atropine, Patching, Near activities


Pennsylvania College of Optometry
United States




National Eye Institute (NEI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:45:10-0400

Clinical Trials [206 Associated Clinical Trials listed on BioPortfolio]

Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the suc...

Effectiveness of Telescopic Magnification in the Treatment of Amblyopia

Amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. The standard treatment for amblyopia consists of patching or pharmacologica...

Trial Comparing Part-Time Versus Full-Time Patching for Severe Amblyopia

The goals of this study are: - To determine whether the visual acuity improvement obtained with part-time (6 hours) patching is equivalent to the visual acuity improvement obtaine...

Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Ch...

Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children

The objectives of the Spectacle Phase are: - In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have s...

PubMed Articles [4392 Associated PubMed Articles listed on BioPortfolio]

Cerebral structural characteristics in children with unilateral amblyopia: a MRI study.

To study the mechanism of the development of amblyopia using the analysis of brain grey matter parameters. The areas primarily associated with visual cortex in children with amblyopia were analyzed.

Audiovisual perception in amblyopia: A review and synthesis.

Amblyopia is a common developmental sensory disorder that has been extensively and systematically investigated as a unisensory visual impairment. However, its effects are increasingly recognized to ex...

Therapeutic contact lenses vs. tight bandage patching and pain following pterygium excision: a prospective randomized controlled study.

The immediate postoperative management of patients undergoing pterygium excision usually includes eye patching in order to alleviate pain and prevent accidental tissue damage. Commonly applied tight p...

Self-perception of School-Aged Children With Amblyopia and Its Association With Reading Speed and Motor Skills.

Reading and eye-hand coordination deficits in children with amblyopia may impede their ability to demonstrate their knowledge and skills, compete in sports and physical activities, and interact with p...

Specific quantification of atropine using molecularly imprinted polymer on graphene quantum dots.

Herein, development of a reliable and specific fluorometric assay was disclosed for the sensitive detection of atropine. The method was designed using the surface molecularly imprinted polymer on high...

Medical and Biotech [MESH] Definitions

A nonspecific term referring to impaired vision. Major subcategories include stimulus deprivation-induced amblyopia and toxic amblyopia. Stimulus deprivation-induced amblyopia is a developmental disorder of the visual cortex. A discrepancy between visual information received by the visual cortex from each eye results in abnormal cortical development. STRABISMUS and REFRACTIVE ERRORS may cause this condition. Toxic amblyopia is a disorder of the OPTIC NERVE which is associated with ALCOHOLISM, tobacco SMOKING, and other toxins and as an adverse effect of the use of some medications.

Analogs and derivatives of atropine.

An extract of absinthium and other bitter herbs, containing 60% alcohol. Prolonged ingestion causes nervousness, convulsions, trismus, amblyopia, optic neuritis, and mental deterioration. (Dorland, 27th ed)

The 3(S)-endo isomer of atropine.

An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE.

More From BioPortfolio on "Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds"

Quick Search


Relevant Topics

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Searches Linking to this Trial