Bibliographic Source(s)

• American Academy of Ophthalmology Pediatric Ophthalmology/Strabismus Panel. Amblyopia. San Francisco (CA): American Academy of Ophthalmology; 2007. 28 p. [110 references]

Guideline Status

This is the current release of the guideline.

It updates a previous version: American Academy of Ophthalmology Pediatric Ophthalmology Panel. Amblyopia. San Francisco (CA): American Academy of Ophthalmology; 2002 Oct. 25 p. [113 references]

All Preferred Practice Patterns are reviewed by their parent panel annually or earlier if developments warrant and updated accordingly. To ensure that all Preferred Practice Patterns are current each is valid for 5 years from the "approved by" date unless superseded by a revision.

Guideline Category

Diagnosis
Evaluation
Management
Prevention
Screening
Treatment

Intended Users

Advanced Practice Nurses
Allied Health Personnel
Health Plans
Nurses
Physician Assistants
Physicians

Guideline Objective(s)

To prevent or reverse vision impairment caused by amblyopia while addressing the following goals:

• Identify children at risk for esotropia
• Examine and diagnose the child with amblyopia or risk factors for amblyopia at the earliest possible stage
• Identify etiology of amblyopia and formulate an appropriate treatment plan
• Inform the family/caregiver of the diagnosis treatment options and care plan
• Inform the primary care provider of the diagnosis and treatment plan and collaborate on ongoing care
• Treat infants and children with amblyopia in order to improve visual acuity facilitate the treatment of strabismus and reduce the likelihood of vision-related disability
• Limit the effect of amblyopia treatment on quality of life
• Lessen the effect of amblyopia on employment and career choices
• Re-evaluate the patient and adjust the treatment plan as necessary

Target Population

Children with amblyopia or at risk for amblyopia

Interventions and Practices Considered

Diagnosis

1. History
2. Examination
   • Assessment of visual acuity and fixation pattern
   • Ocular alignment and motility
   • Red reflex/binocular red reflex (Brückner) test
   • Pupil examination
   • External examination
   • Anterior segment examination
   • Cycloplegic retinoscopy/refraction
   • Funduscopic examination
   • Binocularity/stereoacuity testing

Management/Treatment

1. Optical correction
2. Occlusion therapy
3. Penalization with cycloplegics (atropine homatropine or cyclopentolate) or by altering the refractive correction of the dominant eye
4. Surgery
5. Follow-up evaluation during treatment
6. Counseling and referral

Major Outcomes Considered

• Degree of visual acuity improvement obtained after treatment
• Side effects or complications of treatment of amblyopia

Methods Used to Collect/Select Evidence

Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

In the process of revising this document a detailed literature search of Medline and the Cochrane Library for articles in the English language was conducted on the subject of amblyopia for the years 2001 to 2006.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Strength of Evidence Ratings

Level I: Includes evidence obtained from at least one properly conducted well-designed randomized controlled trial. It could include meta-analyses of randomized controlled trials.

Level II: Includes evidence obtained from the following:

• Well-designed controlled trials without randomization
• Well-designed cohort or case-control analytic studies preferably from more than one center
• Multiple-time series with or without the intervention

Level III: Includes evidence obtained from one of the following:

• Descriptive studies
• Case reports
• Reports of expert committees/organization (e.g. Preferred Practice Patterns [PPP] panel consensus with external peer review)

Methods Used to Analyze the Evidence

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

The results of a literature search on the subject of amblyopia were reviewed by the Pediatric Ophthalmology/Strabismus Panel and used to prepare the recommendations which they rated in two ways. The panel first rated each recommendation according to its importance to the care process. This "importance to the care process" rating represents care that the panel thought would improve the quality of the patient´s care in a meaningful way. The panel also rated each recommendation on the strength of the evidence in the available literature to support the recommendation made.

Rating Scheme for the Strength of the Recommendations

Ratings of Importance to Care Process

Level A defined as most important

Level B defined as moderately important

Level C defined as relevant but not critical

Cost Analysis

One cost-utility analysis was reviewed. This analysis showed that early detection and treatment of amblyopia are highly cost-effective when compared with other interventions in health care.

Method of Guideline Validation

Internal Peer Review

Description of Method of Guideline Validation

These guidelines were reviewed by Council and approved by the Board of Trustees of the American Academy of Ophthalmology (September 8 2007).

Major Recommendations

Ratings of importance to the care process (A-C) and ratings of strength of evidence (I-III) are defined at the end of the "Major Recommendations" field.

Diagnosis

The initial amblyopia evaluation (history and physical examination) includes all components of the comprehensive pediatric ophthalmic evaluation (American Academy of Ophthalmology Basic and Clinical Science Course Subcommittee 2007) with special attention to the potential risk factors for amblyopia such as a positive family history for strabismus amblyopia or media opacity.

History

Although a thorough history generally includes the following items the exact composition varies with the patient's particular problems and needs:

• Demographic data including identification of parent/caregiver and patient's gender and date of birth [A:III]
• Documentation of identity and relationship of historian [B:III]
• The identity of other pertinent health care providers [A:III]
• The chief complaint and reason for the eye evaluation [A:III]
• Current eye problems [A:III]
• Ocular history including prior eye problems diseases diagnoses and treatments [A:III]
• Systemic history; birth weight; prenatal and perinatal history that may be pertinent (e.g. alcohol tobacco and drug use during pregnancy); past hospitalizations and operations; and general health and development [A:III]
• Current medications and allergies [A:III]
• Review of systems [B:III]

Examination

The eye examination consists of an assessment of the physiological function and the anatomic status of the eye and visual system. Documentation of the child's level of cooperation with the examination can be useful in interpreting the results and in making comparisons among the examinations over time. In general the examination may include the following elements:

• Assessment of visual acuity and fixation pattern [A:III]
• Ocular alignment and motility [A:III]
• Red reflex or binocular red reflex (Brückner) test [A:III]
• Pupil examination [A:III]
• External examination [A:III]
• Anterior segment examination [A:III]
• Cycloplegic retinoscopy/refraction [A:III]
• Funduscopic examination [A:III]
• Binocularity/stereoacuity testing [A:III]

Management

Success rates of amblyopia treatment may decline with increasing age (Scheiman et al. 2005; Mohan Saroha & Sharma 2004) [A:I]. However all children should be considered for treatment of amblyopia regardless of age although the difficulty of treatment for both the patient and caregiver should not be underestimated (Dixon-Woods Awan & Gottlob 2006; Yang & Lambert 1995; Koklanis Abel & Aroni 2006). The prognosis for attaining and maintaining essentially normal vision in an amblyopic eye depends on many factors including the age of the patient at detection the cause and severity of amblyopia the history of previous treatment (Scheiman et al. 2005) the duration of amblyopia and compliance with treatment.

The following therapies are used alone or in combination as required to achieve the therapeutic goal.

• Optical correction (Scheiman et al. 2005; Chen et al. 2007; Cotter et al. 2006) [A:I]
• Occlusion (Repka et al. 2005; Pediatric Eye Disease Investigator Group 2002; Pediatric Eye Disease Investigator Group "A comparison" 2003; Repka et al. 2003) [A:I]
• Penalization (Repka et al. 2005; Pediatric Eye Disease Investigator Group 2002; Pediatric Eye Disease Investigator Group "A comparison" 2003; Repka et al. 2004; Pediatric Eye Disease Investigator Group "The course of moderate amblyopia" 2003) [A:I]
• Surgery to treat the cause of the amblyopia (Lam Repka & Guyton 1993; Paysse et al. 2006; Reese & Weingeist 1987) [A:III]

In general occlusive adhesive patches should be used during the initial therapy in many cases of amblyopia [A:III]; however in mild to moderate amblyopia penalization with atropine drops has been shown to be an effective alternative (Repka et al. 2005; Pediatric Eye Disease Investigator Group 2002; Pediatric Eye Disease Investigator Group "A comparison" 2003; Repka et al. 2004; Pediatric Eye Disease Investigator Group "The course of moderate amblyopia" 2003)

Follow-up Evaluation during Treatment

The purpose of the follow-up evaluations is to monitor the response to therapy and adjust the treatment plan as necessary. Follow-up evaluation includes interval history and tolerance to therapy with appropriate examinations and testing as indicated.

The frequency of follow-up evaluations will depend on the age of the patient severity of the amblyopia and intensity of occlusion therapy (high versus low percentage).

Patients who are functionally monocular should wear proper protective eyewear full time even if they do not require corrective lenses [A:III]. A frame approved by the American National Standards Institute Standard No. Z87.1 with polycarbonate lenses should be worn for daily wear and low-eye-risk sports [A:III]. For most ball and contact sports polycarbonate sports goggles should be worn and head and face protection should be added for higher risk activities (American Academy of Pediatrics and American Academy of Ophthalmology 2003; Vinger 1998) [A:III]. Functionally monocular individuals should use approved protective eyewear when participating in contact sports or other potentially harmful activities such as those that involve pellet guns paintballs and personal use of fireworks (Saunte & Saunte 2006; Kennedy Ng & Duma 2006; Endo Ishida & Yamaguchi 2001; Fleischhauer et al 1999; Greven & Bashinsky 2006; Listman 2004; Hargrave Weakley & Wilson 2000) [A:III]. Special goggles industrial safety glasses side shields and full-face shields should be used in these cases [A:III]. Functionally monocular patients should be aware of the need to have regular eye examinations throughout their lives [A:III].

Counseling and Referral

Amblyopia is a long-term problem that requires commitment from the parent/caregiver and ophthalmologist to achieve the best possible outcome.

The ophthalmologist should discuss the findings of the evaluation with the patient when appropriate as well as the parent/caregiver [A:III]. The ophthalmologist should explain the disorder and recruit the family in a collaborative approach to therapy [A:III]. Parents/caregivers of pediatric patients who understand the diagnosis and rationale for treatment are more likely to adhere to treatment recommendations (Newsham 2002; Norman et al. 2003)

Table. Recommended Amblyopia Follow-Up Evaluation Intervals During Active Treatment Period [A:III]

Note: These follow-up intervals were generated by panel consensus.

Definitions:

Ratings of Importance to the Care Process

Level A defined as most important

Level B defined as moderately important

Level C defined as relevant but not critical

Ratings of Strength of Evidence

Level I: Includes evidence obtained from at least one properly conducted well-designed randomized controlled trial. It could include meta-analyses of randomized controlled trials.

Level II: Includes evidence obtained from the following:

• Well-designed controlled trials without randomization
• Well-designed cohort or case-control analytic studies preferably from more than one center
• Multiple-time series with or without the intervention

Level III: Includes evidence obtained from one of the following:

• Descriptive studies
• Case reports
• Reports of expert committees/organization (e.g. preferred practice patterns [PPP] panel consensus with external peer review)

Clinical Algorithm(s)

A clinical algorithm is provided in the original guideline document for "Management of Amblyopia."

References Supporting the Recommendations

• American Academy of Ophthalmology Pediatric Ophthalmology/Strabismus Panel. Preferred practice pattern guidelines. Pediatric eye evaluations. San Francisco (CA): American Academy of Ophthalmology; 2007.



• American Academy of Pediatrics American Academy of Ophthalmology. Joint policy statement. Protective eyewear for young athletes. San Francisco (CA): American Academy of Ophthalmology American Academy of Pediatrics; 2003.



• Chen PL Chen JT Tai MC Fu JJ Chang CC Lu DW. Anisometropic amblyopia treated with spectacle correction alone: possible factors predicting success and time to start patching. Am J Ophthalmol 2007 Jan;143(1):54-60. PubMed



• Cotter SA Pediatric Eye Disease Investigator Group Edwards AR Wallace DK Beck RW Arnold RW Astle WF Barnhardt CN Birch EE Donahue SP Everett DF Felius J Holmes JM Kraker RT Melia M Repka MX Sala NA Silbert DI Weise KK. Treatment of anisometropic amblyopia in children with refractive correction. Ophthalmology 2006 Jun;113(6):895-903. PubMed



• Dixon-Woods M Awan M Gottlob I. Why is compliance with occlusion therapy for amblyopia so hard? A qualitative study. Arch Dis Child 2006 Jun;91(6):491-4. PubMed



• Endo S Ishida N Yamaguchi T. Tear in the trabecular meshwork caused by an airsoft gun. Am J Ophthalmol 2001 May;131(5):656-7. PubMed



• Fleischhauer JC Goldblum D Frueh BE Koerner F. Ocular injuries caused by airsoft guns. Arch Ophthalmol 1999 Oct;117(10):1437-9. PubMed



• Greven CM Bashinsky AL. Circumstance and outcome of ocular paintball injuries. Am J Ophthalmol 2006 Feb;141(2):393. PubMed



• Hargrave S Weakley D Wilson C. Complications of ocular paintball injuries in children. J Pediatr Ophthalmol Strabismus 2000 Nov-Dec;37(6):338-43. PubMed



• Kennedy EA Ng TP Duma SM. Evaluating eye injury risk of Airsoft pellet guns by parametric risk functions. Biomed Sci Instrum 2006;42:7-12. PubMed



• Koklanis K Abel LA Aroni R. Psychosocial impact of amblyopia and its treatment: a multidisciplinary study. Clin Experiment Ophthalmol 2006 Nov;34(8):743-50. PubMed



• Lam GC Repka MX Guyton DL. Timing of amblyopia therapy relative to strabismus surgery. Ophthalmology 1993 Dec;100(12):1751-6. PubMed



• Listman DA. Paintball injuries in children: more than meets the eye. Pediatrics 2004 Jan;113(1 Pt 1):e15-8. PubMed



• Mohan K Saroha V Sharma A. Successful occlusion therapy for amblyopia in 11- to 15-year-old children. J Pediatr Ophthalmol Strabismus 2004 Mar-Apr;41(2):89-95. PubMed



• Newsham D. A randomised controlled trial of written information: the effect on parental non-concordance with occlusion therapy. Br J Ophthalmol 2002 Jul;86(7):787-91. PubMed



• Norman P Searle A Harrad R Vedhara K. Predicting adherence to eye patching in children with amblyopia: an application of protection motivation theory. Br J Health Psychol 2003 Feb;8(Pt 1):67-82. PubMed



• Paysse EA Coats DK Hussein MA Hamill MB Koch DD. Long-term outcomes of photorefractive keratectomy for anisometropic amblyopia in children. Ophthalmology 2006 Feb;113(2):169-76. PubMed



• Pediatric Eye Disease Investigator Group. A comparison of atropine and patching treatments for moderate amblyopia by patient age cause of amblyopia depth of amblyopia and other factors. Ophthalmology 2003 Aug;110(8):1632-7; discussion 1637-8. PubMed



• Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002 Mar;120(3):268-78. PubMed



• Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with atropine in children: experience of the amblyopia treatment study. Am J Ophthalmol 2003 Oct;136(4):630-9. PubMed



• Reese PD Weingeist TA. Pars plana management of ectopia lentis in children. Arch Ophthalmol 1987 Sep;105(9):1202-4. PubMed



• Repka MX Beck RW Holmes JM Birch EE Chandler DL Cotter SA Hertle RW Kraker RT Moke PS Quinn GE Scheiman MM Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003 May;121(5):603-11. PubMed



• Repka MX Cotter SA Beck RW Kraker RT Birch EE Everett DF Hertle RW Holmes JM Quinn GE Sala NA Scheiman MM Stager DR Sr Wallace DK Pediatric Eye Disease Investigator Group. A randomized trial of atropine regimens for treatment of moderate amblyopia in children. Ophthalmology 2004 Nov;111(11):2076-85. PubMed



• Repka MX Wallace DK Beck RW Kraker RT Birch EE Cotter SA Donahue S Everett DF Hertle RW Holmes JM Quinn GE Scheiman MM Weakley DR Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2005 Feb;123(2):149-57. PubMed



• Saunte JP Saunte ME. 33 cases of airsoft gun pellet ocular injuries in Copenhagen Denmark 1998-2002. Acta Ophthalmol Scand 2006 Dec;84(6):755-8. PubMed



• Scheiman MM Hertle RW Beck RW Edwards AR Birch E Cotter SA Crouch ER Jr Cruz OA Davitt BV Donahue S Holmes JM Lyon DW Repka MX Sala NA Silbert DI Suh DW Tamkins SM Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol 2005 Apr;123(4):437-47. PubMed



• Vinger PF. Sports medicine and the eye care professional. J Am Optom Assoc 1998 Jun;69(6):395-413. [21 references] PubMed



• Yang LL Lambert SR. Reappraisal of occlusion therapy for severe structural abnormalities of the optic disc and macula. J Pediatr Ophthalmol Strabismus 1995 Jan-Feb;32(1):37-41. PubMed

Type of Evidence supporting the Recommendations

The type of supporting evidence is identified and graded for selected recommendations (see "Major Recommendations").

Potential Benefits

• Early identification and treatment of children at risk for amblyopia may prevent or reverse vision impairment caused by amblyopia.
• Successful treatment of amblyopia improves visual acuity and lessens the effect of amblyopia on employment and career choices.
• Amblyopia treatment is an important step in the correction of strabismus and good vision in each eye may maintain alignment of the eyes thereby reducing the need for repeat surgery.

Potential Harms

• Children treated with full-time or near full-time occlusion may develop strabismus or occlusion amblyopia in the previously better-seeing eye. Other side effects of treatment are well known and usually mild and transient (e.g. skin irritation). Children wearing a patch should be monitored carefully to avoid accidents.
• Atropine should be used with caution during the first year of life because of systemic side effects and the possibility of blur-induced amblyopia. In a few cases atropine has been associated with the development of strabismus.

Qualifying Statements

• Preferred Practice Patterns provide guidance for the pattern of practice not for the care of a particular individual. While they should generally meet the needs of most patients they cannot possibly best meet the needs of all patients. Adherence to these Preferred Practice Patterns will not ensure a successful outcome in every situation. These practice patterns should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the best results. It may be necessary to approach different patients' needs in different ways. The physician must make the ultimate judgment about the propriety of the care of a particular patient in light of all of the circumstances presented by that patient. The American Academy of Ophthalmology is available to assist members in resolving ethical dilemmas that arise in the course of ophthalmic practice.
• Preferred Practice Patterns are not medical standards to be adhered to in all individual situations. The Academy specifically disclaims any and all liability for injury or other damages of any kind from negligence or otherwise for any and all claims that may arise out of the use of any recommendations or other information contained herein.
• References to certain drugs instruments and other products are made for illustrative purposes only and are not intended to constitute an endorsement of such. Such material may include information on applications that are not considered community standard that reflect indications not included in approved U.S. Food and Drug Administration (FDA) labeling or that are approved for use only in restricted research settings. The FDA has stated that it is the responsibility of the physician to determine the FDA status of each drug or device he or she wishes to use and to use them with appropriate patient consent in compliance with applicable law.

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Clinical Algorithm
Personal Digital Assistant (PDA) Downloads
Quick Reference Guides/Physician Guides

For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.

IOM Care Need

Getting Better
Living with Illness
Staying Healthy

IOM Domain

Effectiveness
Patient-centeredness

Bibliographic Source(s)

• American Academy of Ophthalmology Pediatric Ophthalmology/Strabismus Panel. Amblyopia. San Francisco (CA): American Academy of Ophthalmology; 2007. 28 p. [110 references]

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

American Academy of Ophthalmology without commercial support

Guideline Committee

Pediatric Ophthalmology/Strabismus Panel; Preferred Practice Patterns Committee

Composition of Group that Authored the Guideline

Members of the Pediatric Ophthalmology/Strabismus Panel: Linda M. Christmann MD Chair; Patrick J. Droste MD; Sheryl M. Handler MD American Association for Pediatric Ophthalmology and Strabismus Representative; Richard A. Saunders MD; R. Grey Weaver Jr. MD; Susannah G. Rowe MD MPH Methodologist; Norman Harbaugh MD FAAP American Academy of Pediatrics Representative; Donya A. Powers MD American Academy of Family Physicians Representative

Members of the Preferred Practice Patterns Committee: Sid Mandelbaum MD Chair; Emily Y. Chew MD; Linda M. Christmann MD; Douglas E. Gaasterland MD; Samuel Masket MD; Stephen D. McLeod MD; Christopher J. Rapuano MD; Donald S. Fong MD MPH Methodologist

Financial Disclosures/Conflicts of Interest

This author has disclosed the following financial relationships from January 2006 to August 2007:

Norman Harbaugh MD FAAP: Kids First – Grant support. Kids Time – Equity owner. Medimmune – Lecture fees. Centers for Disease Control Merck United Healthcare – Consultant/Advisor.

Guideline Status

This is the current release of the guideline.

It updates a previous version: American Academy of Ophthalmology Pediatric Ophthalmology Panel. Amblyopia. San Francisco (CA): American Academy of Ophthalmology; 2002 Oct. 25 p. [113 references]

All Preferred Practice Patterns are reviewed by their parent panel annually or earlier if developments warrant and updated accordingly. To ensure that all Preferred Practice Patterns are current each is valid for 5 years from the "approved by" date unless superseded by a revision.

Guideline Availability

Electronic copies: Available from the American Academy of Ophthalmology (AAO) Web site.

Print copies: Available from American Academy of Ophthalmology P.O. Box 7424 San Francisco CA 94120-7424; telephone (415) 561-8540.

Availability of Companion Documents

The following is available:

• Summary benchmarks for preferred practice patterns. San Francisco (CA): American Academy of Ophthalmology; 2007 Nov. 22 p.

Available in Portable Document Format (PDF) and as a Personal Digital Assistant (PDA) download from the American Academy of Ophthalmology (AAO) Web site.

Print copies: Available from American Academy of Ophthalmology P.O. Box 7424 San Francisco CA 94120-7424; telephone (415) 561-8540.

Patient Resources

None available

NGC STATUS

This summary was completed by ECRI on December 1 1998. The information was verified by the guideline developer on January 11 1999. This summary was updated on March 12 2003. The updated information was verified by the guideline developer on April 2 2003. This NGC summary was updated by ECRI Institute on February 5 2008. The updated information was verified by the guideline developer on February 27 2008.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions. Information about the content ordering and copyright permissions can be obtained by calling the American Academy of Ophthalmology at (415) 561-8500.

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