Retinopathy of prematurity: Pathogenesis, epidemiology, classification,

and screening

Author:

David K Coats, MD

Section Editors:

Joseph A Garcia-Prats, MD

Richard A Saunders, MD

Deputy Editor:

Carrie Armsby, MD, MPH

Contributor Disclosures

All topics are updated as new evidence becomes available and our peer
review process is complete.

Literature review current through: Aug 2017. | This topic last

updated: Dec 13, 2016.

INTRODUCTION — Retinopathy of prematurity (ROP) is a developmental vascular

proliferative disorder that occurs in the retina of preterm infants with incomplete
retinal vascularization. Next to cortical blindness, ROP is the most common cause of
childhood blindness in the United States. Other ophthalmologic disorders that occur
frequently in preterm infants include amblyopia, strabismus, and refractive errors.

This topic will review the pathogenesis, epidemiology, classification, and screening
for ROP. The management and prognosis of ROP are discussed separately. (See
"Retinopathy of prematurity: Treatment and prognosis".)

Other common eye problems in preterm infants are discussed separately. (See
"Refractive errors in children" and "Amblyopia in children: Classification, screening,
and evaluation" and "Evaluation and management of strabismus in children".)

THE PRETERM INFANT'S EYE — The size and characteristics of the eye differ in
preterm and term infants:

●The globe diameter is approximately 10 to 14 mm at 28 weeks gestation, compared

with 16 to 17 mm at term.

●The ocular media are frequently hazy in preterm infants and impede visualization of
the fundus. Small peripheral lens vacuoles are common. In addition, an incompletely
involuted hyaloid artery may appear as a white or red strand in the vitreous.
●The blood vessels in the anterior vascular capsule of the lens regress in a consistent
pattern and correlate well with gestational age between 27 and 34 weeks [1].

●Pupillary size in preterm infants is approximately 3 to 4 mm, slightly smaller than at

term. Constriction of the pupils in response to light starts at approximately 30 to 32
weeks gestation and is consistently present after 35 weeks [2].

●Tear production is reduced in preterm infants and may result in drying of the corneas
during an eye examination and increased absorption of topically applied medications
[3].

PATHOGENESIS

Normal vascularization — The sequence of vascularization of the eye is important in

understanding the pathogenesis of ROP. No blood vessels are present in the retina
before approximately 16 weeks gestation. From approximately the sixth week, the
anterior segment of the eye receives its vascular supply from the hyaloid artery. This
artery originates from the optic nerve, passes through the vitreous, and supplies
vessels to both surfaces of the lens and iris. These vessels usually are resorbed by 34
weeks of gestation.

Retinal vascularization normally begins at 15 to 18 weeks gestation. Retinal blood

vessels extend out from the optic disc (where the optic nerve enters the eye) and grow
peripherally. Vascularization in the nasal retina is complete at approximately 36
weeks. Vascular development usually is complete in the temporal retina by 40 weeks,
although maturation may be delayed until 48 to 52 weeks postmenstrual age (PMA) in
preterm infants (figure 1).

Retinal vascularization - left eye

Vascularization of the retina begins at approximately 16 weeks' gestation

at the optic nerve and proceeds peripherally. Retinal vessels reach the
ora serrata (the periphery of the eye) on the nasal side at 32 weeks'
gestation and on the temporal side at 36 to 40 weeks' gestation. The
numbers in the figure are weeks of gestation.

Vascularization in ROP — The pathogenesis of ROP is thought to involve two stages.

An initial injury caused by factors such as hypotension, hypoxia, or hyperoxia, with
free radical formation, injures newly developing blood vessels and disrupts normal
angiogenesis. Following this disruption, vessels either resume normal growth or new
vessels grow abnormally out from the retina into the vitreous. Increased permeability
of these abnormal new vessels (neovascularization) can result in retinal edema and
hemorrhage. Abnormal fibrovascular tissue may develop along with the
neovascularization and later contract, producing traction on the retina. In some severe
cases, this results in retinal distortion or retinal detachment. However, in most
instances, the abnormal vascular tissue regresses with little residual effect.

Regulation of the expression of vascular endothelial growth factor (VEGF) and other
cytokines appear to contribute to both normal retinal vessel growth and abnormal
vascular disruption and subsequent neovascularization [4-10]. The mechanisms that
determine whether initial disruption of normal angiogenesis in ROP will be followed
by resumption of normal vascular development or progression of pathologic
neovascularization are unknown.

Insulin-like growth factor-1 (IGF-1) supports normal retinal vascular growth and
interacts with VEGF [11-13]. The possible role of IGF-1 in ROP has been evaluated
in several series of preterm infants who had serial blood samples and retinal
examinations. In each of these series, decreased serum concentrations of IGF-1 were
associated with the development of ROP [14-18]. With low IGF-1, vessels cease to
grow, the maturing avascular retina becomes hypoxic, and VEGF accumulates. Later,
as IGF-1 levels rise during maturation and reach a critical level, neovascularization
ensues. Activation of a specific VEGF receptor may protect developing retinal vessels
and prevent retinal ischemia induced by oxygen. This was investigated in a study in
newborn mice, in which activation of the VEGF receptor VEGFR-1 by placental
growth factor-1 (PGF-1) decreased the obliteration of retinal vessels by hyperoxia (22
versus 5 percent) and did not induce neovascularization [19]. Stimulation of another
VEGF receptor, VGEFR-2, had no effect on blood vessel survival.

Photoreceptor development — ROP appears to affect photoreceptor development. An

observational study in which retinal sensitivity and retinal responsivity were assessed
by electroretinography between 30 and 72 weeks PMA suggests that photoreceptor
development is altered in prematurity (with or without ROP), that conditions that
affect the photoreceptor cells (eg, ROP, ROP treatment) appear to reduce sensitivity,
and that retinal neuronal behavior may be influenced by extrauterine experience
[20,21].
EPIDEMIOLOGY — ROP affects a substantial number of preterm infants worldwide.
Both the incidence and severity increase with decreasing gestational age (GA) and
birth weight (BW) [22-26].

In a study of 951 preterm infants born (<37 weeks GA) at a single center between
1989 and 1997, ROP developed in 21 percent of patients and severe ROP in 5 percent
(stage ≥3 (figure 2)) [22]. No infant born at >32 weeks GA developed the disorder,
and no infant born at >28 weeks GA required surgical intervention.

In a multicenter study conducted in the United States between October 2000 and
October 2002, the incidence of ROP in preterm infants (BW <1251 g) was 68 percent
[27]. The overall incidence of severe ROP was 36 percent. The incidence of ROP was
8 percent, 19 percent, and 43 percent among infants born at ≥32 weeks, >27 to 31
weeks, and ≤27 weeks gestation, respectively.

The increased incidence of severe ROP with decreasing GA also was demonstrated in
a population-based cohort study from New Zealand and Australia [24]. The overall
incidence of severe ROP among infants born at less than 32 weeks GA was 10 percent.
Severe ROP increased from 3 to 34 percent as GA decreased from 27 to 24 weeks,
respectively.

These studies, which were conducted in resource-rich countries, suggest that infants
born at ≥32 weeks are not at risk for developing ROP. In addition, most infants born
at >28 weeks who develop ROP have mild disease that does not require treatment.

In resource-limited settings, infants who develop severe ROP may be larger and have
a greater estimated GA than those in resource-rich settings [28]. A survey of
ophthalmologists from countries with low, moderate, and high levels of development
found that the mean BW of infants with severe ROP was greater in infants in
developing countries than in developed countries (900 versus 750 g) [29]. Similarly,
the mean GA of infants with severe ROP was greater in developing countries than in
developed countries (26 to 33.5 versus 25 weeks).

The diagnosis of ROP appears to be increasing. In one study, incidence of ROP (any
stage) increased from 12.8 per 1000 low BW (BW <1500 g) infants in 1990 to 125.5
per 1000 low BW infants in 2011 [30]. The authors attributed the increased incidence
to increased neonatal survival, improved awareness of ROP, and implementation of
guidelines on ROP screening. (See 'Screening' below and "Retinopathy of prematurity:
Treatment and prognosis", section on 'Prevention' and "Retinopathy of prematurity:
Treatment and prognosis", section on 'Treatment'.)

Risk factors — The most important risk factor for developing ROP is prematurity.
However, more than 50 separate risk factors have been identified. In multivariate
analysis, low BW, low GA, assisted ventilation for longer than one week, surfactant
therapy, high blood transfusion volume, cumulative illness severity, low caloric intake,
hyperglycemia, and insulin therapy, have been independently associated with higher
rates of ROP [31-38]. Breastmilk feeding appears to play a protective role in
preventing ROP [39,40]. In addition, infants with trisomy 21 appear to be at a lower
risk for ROP compared with other infants [41].

Other possible risk factors include sepsis, fluctuations in blood gas measurements,
intraventricular hemorrhage, bronchopulmonary dysplasia, systemic fungal infection,
and early administration of erythropoietin for the treatment of anemia of prematurity
[31,32,42]. Poor longitudinal weight gain and elevated serum concentrations of IGF-1
and IGFBP-3 have also been used to identify infants at risk for ROP [16,43,44]. (See
'Vascularization in ROP' above and "Anemia of prematurity", section on 'Early EPO
use'.)

Elevated arterial oxygen tension is also thought to contribute [45-47]. However, ROP
is not the only consideration in determining the optimal target oxygen level in preterm
infants. Excessive reduction of target oxygenation saturation has been associated with
increased mortality. (See "Neonatal target oxygen levels for preterm infants", section
on 'High versus low SpO2 targets'.)

Infection may worsen the course of ROP. In one study of affected infants, those with
candidemia were more likely to reach threshold ROP and require surgical intervention
(odds ratio [OR] 7.4, 95% CI 1.7-32.1) compared with those without candidemia [48].
Infection was also associated with poor outcome following laser photocoagulation.

CLASSIFICATION — The International Classification for Retinopathy of

Prematurity (ICROP) provides a uniform approach to documenting the extent and
severity of disease and is described in detail in the figure (figure 2) [49].

International Classification of Retinopathy of Prematurity

International Classification of Retinopathy of Prematurity

Classification of ROP based upon the International Classification of
Retinopathy of Prematurity. The diagram depicts the left eye and is used
to document the location and extent of ROP.

ROP: retinopathy of prematurity.

References:

1. International Committee for the Classification of Retinopathy of Prematurity. The

International Classification of Retinopathy of Prematurity revisited. Arch Ophthalmol 2005;
123:991.
2. Katz X, Kychenthal A, Dorta P. Zone I retinopathy of prematurity. J AAPOS 2000; 4:373.
3. Wallace DK, Kylstra JA, Chesnutt DA. Prognostic significance of vascular dilation and
tortuosity insufficient for plus disease in retinopathy of prematurity. J AAPOS 2000; 4:224.
4. Good WV, Early Treatment for Retinopathy of Prematurity Cooperative Group. The Early
Treatment for Retinopathy Of Prematurity Study: structural findings at age 2 years. Br J
Ophthalmol 2006; 90:1378.

Figure adapted from: An international classification of retinopathy of

prematurity. The Committee for the Classification of Retinopathy of
Prematurity. Arch Ophthalmol 1984; 102:1130.

Graphic 81495 Version 5.0

This system facilitates communication among care providers and promotes

collaborative clinical investigation. Four features are evaluated:

●Zone – Describes the disease location on the retinal surface in relation to the disc,
from the central zone (I) to the outer crescent (zone III).

●Stage – Describes the severity from mildest disease (flat white line of demarcation
[stage 1]) to most severe (total retinal detachment [stage 5]).

●Extent – Described by dividing the retinal surface in 12 sections, similar to hours of

a clock.

●Presence or absence of plus disease, the most important indicator of disease severity.

"Threshold ROP" is a term that was previously used to describe the threshold at which
treatment was needed. However, treatment is now initiated when the infant develops
high-risk prethreshold ROP, also called "type I ROP." Type I ROP is defined as any
of the following (see "Retinopathy of prematurity: Treatment and prognosis", section
on 'Treatment'):

●Any stage ROP with plus disease in zone I

●Stage 3 ROP without plus disease in zone I

●Stage 2 or 3 ROP with plus disease in zone II

NATURAL HISTORY — The course of ROP is more correlated with postmenstrual

age (PMA) than postnatal age. ROP typically begins approximately 34 weeks PMA,
although it may be seen as early as 30 to 32 weeks [23]. In a large natural history
study, stages 1, 2, and 3 ROP (figure 2) occurred at a median PMA of 34.3, 35.4, and
36.6 weeks, respectively [23].

ROP advances irregularly until 40 to 45 weeks PMA but resolves spontaneously in

the majority of infants. In a natural history study, in which two-thirds of infants with
birth weight (BW) ≤1250 g developed some degree of ROP, treatment for severe
disease was needed in only 6 percent [23].

Regression of ROP also depends upon PMA and the location of disease. In one report
of 766 children from the natural history study, involution began at a mean PMA of
38.6 weeks, and before 44 weeks in 90 percent of patients [50]. The outcome was
favorable in 99 percent of infants when ROP resolved by moving from zone II to III.
Partial or total retinal detachment was never seen when ROP was limited to zone III
in serial examinations.

Ocular outcome is typically poor in infants with severe untreated ROP. This was
evaluated at 5.5 years corrected age in infants with BW ≤1250 g who were enrolled in
the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity [51]. Among
untreated eyes, poor structural outcomes (eg, central retinal fold, severe retinal
detachment) occurred in 3.1 percent of eyes, and poor Snellen visual acuity (20/200 or
worse) occurred in 5.1 percent of eyes. All infants with a poor structural outcomes
and nearly all poor visual acuity outcomes had a history of severe ROP (zone II ROP
involving >6 clock hours of stage 3+ disease or zone I ROP). Poor visual acuity
occurred in only 2 of 110 eyes (1.8 percent) when ROP was observed only in zone III.

SCREENING

Evaluation — The screening evaluation consists of a comprehensive eye examination

performed by an ophthalmologist with expertise in neonatal disorders [52]. The pupil
must be dilated in order to visualize the vitreous and retina. We recommend
instillation in the eye of a combination eyedrop (Cyclomydril, which contains weak
concentrations of phenylephrine and cyclopentolate) 30 minutes or more before the
examination. Both manipulation of the eye and the drops used to dilate the pupil can
produce systemic sequelae, most notably bradycardia and cardiac arrhythmias [53].
Therefore, careful monitoring of the infant throughout the examination procedure is
essential. Topical anesthetic can be used if the examining clinician prefers.

The retina is examined by looking through the pupil with an indirect ophthalmoscope
with a 20 or 28 diopter condensing lens while the eyelids are retracted with a
speculum. ROP is most commonly visualized in the peripheral retina, which often is
obscured by the iris. In order to completely view this area, a scleral depressor is used
to indent the eye externally. ROP, if present, is described using the standardized
classification (figure 2). (See 'Classification' above.)

Alternatively, telemedicine systems can be used to identify infants with potentially

severe ROP. (See 'Telemedicine screening' below.)

Screening criteria — We suggest screening all infants with birth weight (BW) ≤1500
g or gestational age (GA) <30 weeks, as well as those with BW between 1500 g and
2000 g or GA ≥30 weeks whose clinical course places them at increased risk for ROP
(as determined by the neonatologist). This practice is consistent with the 2013 Joint
Statement of the American Academy of Pediatrics (AAP) Section on Ophthalmology,
the American Academy of Ophthalmology (AAO), the American Association for
Pediatric Ophthalmology and Strabismus (AAPOS), and the American Association of
Certified Orthoptists (AACO) [52]. These screening criteria, however, are
controversial. In a Canadian study, screening infants with a BW of ≤1200 g was a
more cost-effective strategy [54].

Screening for ROP is a labor-intensive process with a relatively low yield; less than
10 percent of infants who are screened require treatment [55]. Incorporation of
postnatal risk factors into the screening guidelines may increase the yield of screening.
Models using various combinations of GA, BW, postnatal weight gain, and serum
IGF-1 levels to predict increased risk of severe ROP have been developed
[43,44,56-59]. In initial validation studies, the sensitivity of these models approached
100 percent, and the specificity ranged from 32 to 84 percent. However, in a
subsequent retrospective validation, the sensitivity of one such model using weight
and IGF-1 level in detecting severe ROP among Mexican infants born at <32 weeks
gestation was only 84.7 percent [60]. The use of models incorporating postnatal risk
factors to screen for increased risk of severe ROP has the potential to reduce the
number of infants requiring ophthalmologic examinations. However, these methods
require additional validation in other populations before changes to the screening
recommendations can be made.

Evaluation schedule — We initiate screening examinations at 30 weeks postmenstrual

age (PMA) for infants born at 22 to 26 weeks and at 4 weeks of chronologic age for
infants born at ≥27 weeks (table 1). Our screening schedule conforms to
evidence-based screening criteria, which were developed for infants with birth weight
≤1250 g or GA <31 weeks based upon natural history data from two large randomized
trials [61,62]. In these studies and a subsequent randomized trial [63], retinal
conditions that indicated a risk of poor outcome were not observed before 31 weeks
PMA or 4 weeks postnatal age in 99 percent of infants [64]. Although treatable ROP
rarely occurs before 31 weeks PMA, we initiate screening at 30 weeks PMA to
account for the possibility of errors in dating, examination delays due to medical
status, and to permit flexibility in scheduling.

Additional examinations are performed at intervals of one to three weeks until the
retinal vessels have completely grown out to the ora serrata (periphery of the retina).
If ROP develops, the eyes are examined more frequently, depending upon the severity
of disease and rate of progression. The AAP/AAO/AAPOS/AACO joint statement
suggests follow-up examinations according to the following schedule [52].

Follow-up within one week is recommended for infants with any of the following
[52,65]:

●Immature vascularization in zone I, without ROP

●Immature retina that extends into posterior zone II, near the boundary of zone I

●Stage 1 or 2 ROP in zone I

●Stage 3 ROP in zone II

●Suspected aggressive posterior ROP

Follow-up within one to two weeks is recommended for infants with any of the
following:

●Immature vascularization in posterior zone II

●Stage 2 ROP in zone II

●Regressing ROP in zone I

Follow-up within two weeks is recommended for infants with any of the following:

●Stage 1 ROP in zone II

●Immature vascularization in zone II, without ROP

●Regressing ROP in zone II

Follow-up within two to three weeks is recommended for infants with either/both of
the following:

●Stage 1 or 2 ROP in zone III

●Regressing ROP in zone III

When an infant is discharged home before the retinal vasculature is mature, parents
must understand the importance of timely follow-up [52,66].

Discontinuation — Screening examinations continue until the risk of serious disease

has passed, ROP regresses and the vasculature matures, or treatment is needed.
Screening examinations can be discontinued when any of the following conditions
occurs:
●Lack of development of advanced ROP by 45 weeks PMA; some experts suggest
extending screening to 50 weeks PMA [52].

●Progression of retinal vascularization into zone III without previous ROP in zone I
or zone II.

●Documented mild, regressing ROP in zone III in a low-risk infant.

●Full retinal vascularization.

In large randomized trials, these signs indicated that the risk of visual loss from ROP
was minimal or had passed [50,61,62].

Telemedicine screening — Telemedicine systems can be used to identify infants with

potentially severe ROP [67-69]. The process involves using wide-angle ocular digital
fundus photography to create digital retinal images. Up to six standard images may be
taken. The images are then transmitted to a remote location for interpretation. Initially,
telemedicine was used to provide screening for remote locations without access to an
ophthalmologist skilled in ROP screening; however, telemedicine is increasingly used
as the primary mode of screening even in locations with access to an ophthalmologist
skilled ROP screening.

Digital retinal photography has high accuracy for the detection of clinically
significant ROP. In the Telemedicine Approaches to Evaluating Acute-phase ROP
(e-ROP) study, in which 1257 infants with BW <1251 g underwent regularly
scheduled evaluations, both by an ophthalmologist and by non-physician staff using
wide-field digital camera, remote grading of the images of both eyes had high
sensitivity (90 percent) and specificity (87 percent) for detecting referral-warranted
ROP (defined as zone I ROP, stage 3 ROP or worse, or plus disease) [69]. The
accuracy of wide-angle photography for detection of mild levels of ROP is less clear
[67]. However, strategies designed to identify referral-warranted ROP do not rely on
identification of mild disease for success.

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Here are the patient education articles that are relevant to this topic. We encourage
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●Basics topic (see "Patient education: Retinopathy of prematurity (ROP) (The
Basics)")

SUMMARY AND RECOMMENDATIONS

●Retinopathy of prematurity (ROP) is a developmental proliferative vascular disorder

that occurs in the retina of preterm infants with incomplete retinal vascularization. It
is a common cause of potentially preventable childhood blindness in the United States.
(See 'Introduction' above.)

●The incidence and severity of ROP increase with decreasing gestational age (GA)
and birth weight (BW). (See 'Epidemiology' above.)

●The International Classification for ROP provides a uniform approach to

documenting the extent and severity of disease (figure 2). It is based upon four
features: zone, stage, extent, and presence or absence of plus disease. (See
'Classification' above.)

●ROP typically begins approximate 34 weeks postmenstrual age (PMA), but may be
seen as early as 30 to 32 weeks. It advances irregularly until 40 to 45 weeks PMA, but
resolves spontaneously in the majority of infants. (See 'Natural history' above.)

●We suggest screening for ROP in all infants with BW ≤1500 g or GA of <30 weeks
(Grade 2C). In addition, screening is warranted in select infants with BW between
1500 g and 2000 g or GA of ≥30 weeks whose clinical course places them at
increased risk for ROP (as determined by the neonatologist). The screening evaluation
consists of a comprehensive eye examination performed by an ophthalmologist with
expertise in neonatal disorders. Alternatively, telemedicine systems can be used to
identify infants with potentially severe ROP. (See 'Screening' above and
'Telemedicine screening' above.)

●We initiate screening examinations at 30 weeks PMA for infants born at 22 to 26

weeks and at 4 weeks of chronologic age for children born at ≥27 weeks (table 1).
Additional examinations are performed at intervals of one to three weeks, depending
on the severity of ROP and the health of the infant. Screening examinations continue
until the risk of serious disease has passed, ROP regresses and the vasculature matures,
or treatment is needed. (See 'Evaluation schedule' above and 'Discontinuation' above.)

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Patient education: Retinopathy of prematurity (ROP) (The Basics)

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Written by the doctors and editors at UpToDate

What is retinopathy of prematurity? — Retinopathy of prematurity (also called "ROP")

is an eye condition that happens in babies who are born very early or are very small.
In ROP, extra blood vessels grow inside the eye. They can damage the tissue at the
back of the eye, called the "retina." This part of the eye contains the cells that react to
light. Damage to the retina can cause vision problems and even blindness.

ROP usually goes away as a baby grows. But if ROP is severe, a baby might need
treatment.

What are the symptoms of ROP? — ROP does not usually cause symptoms. But if a
baby is born very early or is very small, doctors will check for signs of ROP.

Is there a test for ROP? — Yes. An eye doctor with special training in caring for
newborn babies can do an exam to check for ROP. A baby might not need this exam
until he or she is 4 to 8 weeks old.

After the first exam, an eye doctor will probably check your baby's eyes every 1 to 3
weeks. He or she can check to see if the ROP is getting worse or better. If it gets
worse, your baby might need treatment.

How is ROP treated? — Some babies do not need any treatment for ROP. But severe
ROP needs treatment. If severe ROP is not treated, it can cause blindness.

Doctors usually treat ROP with a procedure called "photocoagulation." This treatment
uses a powerful light called a "laser" to seal or destroy the extra blood vessels.

Another treatment involves injecting the eye with special medicines. These medicines
stop the extra blood vessels from growing.

Sometimes, ROP pulls the retina out of its normal place in the eye. When this happens,
it is called a "retinal detachment." Doctors can do surgery to try to put the retina back
in place. But there might be too much damage for surgery to fix it completely. If this
happens to your baby, he or she might not see well from that eye.

Can ROP be prevented? — Right now, doctors do not have a good way to keep babies
from getting ROP. Feeding your baby breast milk can help protect him or her from
getting ROP. Breast milk has other benefits for babies, too.

If your baby needs eye exams to check for ROP, make sure you go to all the
appointments. If you do this, your baby can get treatment for ROP if he or she needs
it.
More on this topic

Patient education: What to expect in the NICU (The Basics)

Patient education: How to plan and prepare for a healthy pregnancy (The Basics)
Patient education: Deciding to breastfeed (The Basics)
Patient education: Breastfeeding (The Basics)

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