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## Complete Summary

#### GUIDELINE TITLE

Amblyopia.

#### 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for 5 years from the \"approved by\" date unless superseded by a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.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Amblyopia including:

-   Amblyopia, unspecified

-   Strabismic amblyopia (suppression)

-   Deprivation amblyopia

-   Refractive amblyopia, including anisometropic and isometropic
    amblyopia

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Screening\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Ophthalmology\
Pediatrics

#### 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

### METHODOLOGY

#### 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).

### RECOMMENDATIONS

#### 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** \[A:III\]

  -----------------------------------------------------------------------------
  **Patient   **High-Percentage         **Low-Percentage      **Maintenance
  Age         Occlusion (70% or more of Occlusion (\<70% of   Treatment or
  (years)**   waking                    waking hours/\<6      Observation**
              hours/[\>]{.underline}6   hours per day)        
              hours per day)**          Penalization**        
  ----------- ------------------------- --------------------- -----------------
  0-1         1-4 weeks                 2-8 weeks             1-4 months

  1-2         2-8 weeks                 2-4 months            2-4 months

  2-3         3-12 weeks                2-4 months            2-4 months

  3-4         4-16 weeks                2-6 months            2-6 months

  4-5         4-16 weeks                2-6 months            2-6 months

  5-7         6-16 weeks                2-6 months            2-6 months

  7-9         8-16 weeks                3-6 months            3-12 months
  -----------------------------------------------------------------------------

**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.\"

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=11751)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE 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

#### 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.

### IMPLEMENTATION OF THE GUIDELINE

#### 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](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### 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.

#### DATE RELEASED

1992 Feb (revised 2007 Sep)

#### GUIDELINE DEVELOPER(S)

American Academy of Ophthalmology - Medical Specialty Society

#### 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](http://one.aao.org/CE/PracticeGuidelines/PPP.aspx).

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](http://one.aao.org/CE/PracticeGuidelines/SummaryBenchmarks.aspx).

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.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008