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## Complete Summary

#### GUIDELINE TITLE

Screening examination of premature infants for retinopathy of
prematurity.

#### BIBLIOGRAPHIC SOURCE(S)

Section on Ophthalmology American Academy of Pediatrics, American
Academy of Ophthalmology, American Association for Pediatric
Ophthalmology and Strabismus. Screening examination of premature infants
for retinopathy of prematurity \[published erratum appears in Pediatrics
2006 Sep;118(3):1324\]. Pediatrics 2006 Feb;117(2):572-6. \[16
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16452383)

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Screening examination of
premature infants for retinopathy of prematurity. Pediatrics 2001
Sep;108(3):809-11.

All policy statements from the American Academy of Pediatrics
automatically expire 5 years after publication unless reaffirmed,
revised, or retired at or before that time.

### 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)

Retinopathy of prematurity

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Prevention\
Screening

#### CLINICAL SPECIALTY

Family Practice\
Ophthalmology\
Pediatrics

#### INTENDED USERS

Advanced Practice Nurses\
Health Care Providers\
Hospitals\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To present the attributes on which an effective program for detecting
and treating retinopathy of prematurity (ROP) could be based, including
the timing of initial examination and subsequent reexamination intervals

#### TARGET POPULATION

Low birth weight premature infants in the United States

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Screening Examination and Management**

1.  Carefully timed retinal screening examination after pupillary
    dilation using binocular indirect ophthalmoscopy

2.  Follow-up examinations performed at regular intervals on the basis
    of retinal findings

3.  Ablative therapy

4.  Parental counseling

5.  Follow-up after hospital transfer or discharge

#### MAJOR OUTCOMES CONSIDERED

-   Blindness

-   Effectiveness of timely retinal screening examination for and early
    treatment of retinopathy of prematurity

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

1.  Infants with a birth weight of less than 1500 g or with a
    gestational age of 30 weeks or less (as defined by the attending
    neonatologist) and selected infants with a birth weight between 1500
    and 2000 g or gestational age of more than 30 weeks with an unstable
    clinical course, including those requiring cardiorespiratory support
    and who are believed by their attending pediatrician or
    neonatologist to be at high risk, should have retinal screening
    examinations performed after papillary dilation using binocular
    indirect ophthalmoscopy to detect retinopathy of prematurity (ROP).
    One examination is sufficient only if it unequivocally shows the
    retina to be fully vascularized in each eye. Effort should be made
    to minimize the discomfort and systemic effect of this examination
    by pretreatment of the eyes with a topical anesthetic agent such as
    proparacaine; consideration also may be given to the use of
    pacifiers, oral sucrose, etc.

2.  Retinal examinations in preterm infants should be performed by an
    ophthalmologist who has sufficient knowledge and experience to
    enable accurate identification of the location and sequential
    retinal changes of ROP. \"The International Classification of
    Retinopathy of Prematurity Revisited\" (International Committee for
    the Classification of Retinopathy of Prematurity, 2005) should be
    used to classify, diagram, and record these retinal findings at the
    time of examination.

3.  The initiation of acute-phase ROP screening should be based on the
    infant\'s age. The onset of serious ROP correlates better with
    postmenstrual age (gestational age at birth plus chronologic age)
    than with postnatal age (Palmer et al., 1991). That is, the youngest
    infants at birth take the longest time to develop serious ROP. This
    knowledge has been used previously in conducting a screening
    schedule (\"The design of the multicenter study,\" 1999; Hutchinson
    et al., 1998). The Table below was developed from an evidence-based
    analysis of the Multicenter Trial of Cryotherapy for Retinopathy of
    Prematurity natural history data and confirmed by the Light
    Reduction in ROP Study, which was conducted a decade later (Reynolds
    et al., 1998). It represents a suggested schedule for the timing of
    the initial eye examinations based on postmenstrual age and
    chronologic (postnatal) age to detect ROP before it becomes severe
    enough to result in retinal detachment while minimizing the number
    of potentially traumatic examinations (Reynolds et al., 2002). The
    Table provides a schedule for detecting ROP potentially damaging to
    the retina with 99% confidence.

**Table. Timing of First Eye Examination Based on Gestational Age at
Birth**

  -------------------------------------------------------------------------
  **Gestational Age at Birth,        **Age at Initial     
  weeks**                            Examination, weeks** 
  ---------------------------------- -------------------- -----------------
                                     **Postmenstrual**    **Chronologic**

  22\*                               31                   9

  23\*                               31                   8

  24                                 31                   7

  25                                 31                   6

  26                                 31                   5

  27                                 31                   4

  28                                 32                   4

  29                                 33                   4

  30                                 34                   4

  31\*\*                             35                   4

  32\*\*                             36                   4
  -------------------------------------------------------------------------

Shown is a schedule for detecting prethreshold ROP with 99% confidence,
usually well before any required treatment.

\* This guideline should be considered tentative rather than
evidence-based for infants with a gestational age of 22 to 23 weeks
because of the small number of survivors in these gestational age
categories.

\*\* If necessary.

4.  Follow-up examinations should be recommended by the examining
    ophthalmologist on the basis of retinal findings classified
    according to the international classification (International
    Committee for the Classification of Retinopathy of Prematurity,
    2005). The following schedule is suggested (see Figure 1 in the
    original guideline document):

> 1-week or less follow-up

-   stage 1 or 2 ROP: zone I

-   stage 3 ROP: zone II

> 1- to 2-week follow-up

-   immature vascularization: zone I\--no ROP

-   stage 2 ROP: zone II

-   regressing ROP: zone I

> 2-week follow-up

-   stage 1 ROP: zone II

-   regressing ROP: zone II

> 2- to 3-week follow-up

-   immature vascularization: zone II\--no ROP

-   stage 1 or 2 ROP: zone III

-   regressing ROP: zone III

> The presence of plus disease (defined as dilation and tortuosity of
> the posterior retinal blood vessels, see below) in zones I or II
> suggests that peripheral ablation, rather than observation, is
> appropriate (Reynolds et al., 2002).

5.  Practitioners involved in the ophthalmologic care of preterm infants
    should be aware that the retinal findings that require strong
    consideration of ablative treatment were revised recently according
    to the Early Treatment for Retinopathy of Prematurity Randomized
    Trial study (Early Treatment of Retinopathy of Prematurity
    Cooperative Group, 2003). The finding of threshold ROP, as defined
    in the Multicenter Trial of Cryotherapy for Retinopathy of
    Prematurity, may no longer be the preferred time of intervention.
    Treatment may also be initiated for the following retinal findings:

    -   zone I ROP: any stage with plus disease

    -   zone I ROP: stage 3\--no plus disease

    -   zone II: stage 2 or 3 with plus disease

> Plus disease is defined as a degree of dilation and tortuosity of the
> posterior retinal blood vessels as defined by a standard photograph
> (\"Multicenter trial of cryotherapy,\" 1988; International Committee
> for the Classification of Retinopathy of Prematurity, 2005). Special
> care must be used in determining the zone of disease. The number of
> clock hours of disease may no longer be the determining factor in
> recommending ablative treatment. Treatment should generally be
> accomplished, when possible, within 72 hours of determination of
> treatable disease to minimize the risk of retinal detachment.

6.  The conclusion of acute retinal screening examinations should be
    based on age and retinal ophthalmoscopic findings (Reynolds et al.,
    2002). Findings that suggest that examinations can be curtailed
    include the following:

    -   zone III retinal vascularization attained without previous zone
        I or II ROP (if there is examiner doubt about the zone or if the
        postmenstrual age is less than 35 weeks, confirmatory
        examinations may be warranted)

    -   full retinal vascularization

    -   postmenstrual age of 45 weeks and no prethreshold disease
        (defined as stage 3 ROP in zone II, any ROP in zone I) or worse
        ROP is present; or

    -   regression of ROP (Repka, Palmer, & Tung, 2000) (care must be
        taken to be sure that there is no abnormal vascular tissue
        present that is capable of reactivation and progression)

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7.  Communication with the parents by members of the staff is very
    important. Parents should be aware of ROP examinations and should be
    informed if their child has ROP, with subsequent updates on ROP
    progression. The possible consequences of serious ROP should be
    discussed at the time that a significant risk of poor visual outcome
    develops. Documentation of such conversations with parents in the
    nurse or physician notes is highly recommended.

8.  Responsibility for examination and follow-up of infants at risk of
    ROP must be carefully defined by each neonatal intensive care unit
    (NICU). Unit-specific criteria with respect to birth weight and
    gestational age for examination for ROP should be established for
    each NICU by consultation and agreement between neonatology and
    ophthalmology services. These criteria should be recorded and should
    automatically trigger ophthalmologic examinations. If hospital
    discharge or transfer to another neonatal unit or hospital is
    contemplated before retinal maturation into zone III has taken place
    or if the infant has been treated by ablation for ROP and is not yet
    fully healed, the availability of appropriate follow-up
    ophthalmologic examination must be ensured, and specific arrangement
    for that examination must be made before such discharge or transfer
    occurs. The transferring primary physician, after communication with
    the examining ophthalmologist, should have the responsibility for
    communicating what eye examinations are needed and their required
    timing to the infant\'s new primary physician. The new primary
    physician should ascertain the current ocular examination status of
    the infant from the record and through communication with the
    transferring physician so that any necessary examinations by an
    ophthalmologist with ongoing experience and expertise in examination
    of preterm infants for ROP can be arranged promptly at the receiving
    facility or on an outpatient basis if discharge is contemplated
    before the need for continued examination has ceased, as outlined in
    recommendation 6. If responsibility for arranging follow-up
    ophthalmologic care after discharge is delegated to the parents,
    they should be made to understand the potential for severe visual
    loss, including blindness; that there is a critical time window to
    be met if treatment is to be successful; and that timely follow-up
    examination is essential to successful treatment. This information
    preferably should be communicated both verbally and in writing. If
    such arrangements for communication and follow-up after transfer or
    discharge cannot be made, the infant should not be transferred or
    discharged until appropriate follow-up examination can be arranged
    by the unit that is discharging the infant.

> Pediatricians and other practitioners who care for infants who have
> had ROP, regardless of whether they require treatment, should be aware
> that these infants may be at risk of other seemingly unrelated visual
> disorders such as strabismus, amblyopia, cataract, etc. Ophthalmologic
> follow-up for these potential problems after discharge from the NICU
> is indicated.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=8713)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically
stated.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Identification of the relatively few preterm infants who require
    treatment for retinopathy of prematurity from among the much larger
    number of at-risk infants while minimizing the number of stressful
    examinations required for these sick infants

-   Decrease in the incidence of unfavorable structural and visual
    outcomes in low birth weight premature infants

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   Any screening program designed to implement an evolving standard of
    care has inherent defects, such as overreferral or underreferral,
    and by its very nature cannot duplicate the precision and rigor of a
    scientifically based clinical trial.

-   The guidance in this report does not indicate an exclusive course of
    treatment or serve as a standard of medical care. Variations, taking
    into account individual circumstances, may be appropriate.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

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

#### IOM CARE NEED

Getting Better\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Timeliness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Section on Ophthalmology American Academy of Pediatrics, American
Academy of Ophthalmology, American Association for Pediatric
Ophthalmology and Strabismus. Screening examination of premature infants
for retinopathy of prematurity \[published erratum appears in Pediatrics
2006 Sep;118(3):1324\]. Pediatrics 2006 Feb;117(2):572-6. \[16
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16452383)

#### ADAPTATION

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

#### DATE RELEASED

2001 Sep (revised 2006 Feb)

#### GUIDELINE DEVELOPER(S)

American Academy of Ophthalmology - Medical Specialty Society\
American Academy of Pediatrics - Medical Specialty Society\
American Association for Pediatric Ophthalmology and Strabismus -
Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Pediatrics

#### GUIDELINE COMMITTEE

American Academy of Pediatrics Section on Ophthalmology, 2003-2004

Subcommittee on Retinopathy of Prematurity, 2003-2005

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*American Academy of Pediatrics Section on Ophthalmology, 2003-2004*:
Steven J. Lichtenstein, MD, *Chairperson*; Edward G. Buckley, MD; George
S. Ellis, MD; Jane D. Kivlin, MD; Gregg T. Lueder, MD; James B. Ruben,
MD; Gary T. Denslow, MD, *Immediate Past Chairperson*

*Liaisons*: Michael R. Redmond, MD, American Academy of Ophthalmology;
Michael X. Repka, MD, American Association of Pediatric Ophthalmology
and Strabismus

*Staff*: S. Niccole Alexander, MPP

*Subcommittee on Retinopathy of Prematurity, 2003-2005*: \* Walter M.
Fierson, MD, *Chairperson*; John Flynn, MD; William Good, MD; Dale L.
Phelps, MD; James Reynolds, MD; Richard Saunders, MD

\* Lead author

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Screening examination of
premature infants for retinopathy of prematurity. Pediatrics 2001
Sep;108(3):809-11.

All policy statements from the American Academy of Pediatrics
automatically expire 5 years after publication unless reaffirmed,
revised, or retired at or before that time.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Academy of Pediatrics
(AAP) Policy Web
site](http://aappolicy.aappublications.org/cgi/content/full/pediatrics;117/2/572).

Print copies: Available from American Academy of Pediatrics, 141
Northwest Point Blvd., P.O. Box 927, Elk Grove Village, IL 60009-0927.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on May 15, 2003. The information
was verified by the guideline developer on June 9, 2003. This NGC
summary was updated by ECRI on March 31, 2006. The updated information
was verified by the guideline developer on April 11, 2006.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please contact the
Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest
Point Blvd, Elk Grove Village, IL 60007.

### DISCLAIMER

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Date Modified: 11/3/2008