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J Cataract Refract Surg. Author manuscript; available in PMC 2022 February 01.
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Published in final edited form as:

J Cataract Refract Surg. 2021 February 01; 47(2): 172–177. doi:10.1097/j.jcrs.0000000000000412.

Outcomes of Secondary Intraocular Lens Implantation in the

Infant Aphakia Treatment Study
Deborah K. VanderVeen, MD1,*, Carolyn D. Drews-Botsch, MPH, PhD2, Azhar Nizam, MS3,
Erick D. Bothun, MD4, Lorri B. Wilson, MD5, M Edward Wilson, MD6, Scott R. Lambert, MD7,
Infant Aphakia Treatment Study#
1.Department of Ophthalmology, Boston Children’s Hospital, Harvard Medical School, Boston MA
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2.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA

3.Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory
University, Atlanta, GA
4.Department of Ophthalmology, Mayo Clinic, Rochester MN
5.Department of Ophthalmology, Casey Eye Institute, Oregon Health & Science University School
of Medicine, Portland, OR
6.Department of Ophthalmology, Storm Eye Institute, Medical University of South Carolina,
Charleston, SC
7.Department of Ophthalmology, Stanford University School of Medicine, Stanford, CA
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Abstract
Purpose: To report outcomes of secondary intraocular lens (IOL) implantation in the Infant
Aphakia Treatment Study (IATS)

Setting: Multicenter clinical practice

Design: Secondary analysis of patients enrolled in a randomized clinical trial

Methods: Details regarding all secondary IOL surgeries conducted in children enrolled in the
IATS were compiled. We evaluated visual outcomes, refractive outcomes, and adverse events at
age 10 ½ years. Comparisons were made to eyes that remained aphakic and to eyes randomized to
primary IOL placement.

Results: 55/57 patients randomized to aphakia with contact lens correction were seen for the 10
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½ year study visit; 24/55 eyes (44%) had secondary IOL surgery. Median age at IOL surgery was

Corresponding author: Deborah VanderVeen, MD, 300 Longwood Avenue, Fegan 4, Boston MA 02115,
Deborah.vanderveen@childrens.harvard.edu.
*Co-first author
#The Infant Aphakia Study Group is found in Appendix 1.
Paper presentation at the American Academy of Ophthalmology Annual Meeting, 2019, San Francisco
Financial Disclosures: None of the authors have conflicting relationships or financial disclosures relevant to this submission; unrelated
disclosures:
Deborah VanderVeen: Retrophin (Grant support), Ophtec (research study without support)
M Edward Wilson: Retrophin (Grant support), EyePoint Pharma (Grant support)
 VanderVeen et al. Page 2

5.4 years (range 1.7 to 10.3 years). Mean absolute prediction error was 1.0 ± 0.7D. At age 10 ½
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years, the median log MAR VA was 0.9 (range 0.2 to 1.7), similar to VA in the 31 eyes still
aphakic (0.8, range 0.1 to 2.9); the number of eyes with stable or improved VA scores between the
4 ½ and 10 ½ year study visits was also similar (78% secondary IOL eyes, 84% aphakic eyes). For
eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age
10 ½ years was −3.2 ±2.7D (range −9.9D to 1.1D), compared to −5.5 ±6.6 D (n=53, range −26.5
to 3.0D) in eyes with primary IOL (p=0.03).

Conclusions: Delayed IOL implantation allows a more predictable refractive outcome at age 10
½ years, though the range of refractive error is still large.

Visually significant cataracts in infants are typically surgically removed early in life to
minimize deprivation amblyopia.1 Traditionally, infant eyes are left aphakic, with refractive
correction provided by either contact lenses or spectacles.2 In unilateral cases, it is difficult
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to obtain good visual acuity because of the interocular competition with the phakic eye; poor
visual results are generally attributed to deprivation amblyopia.3 The challenges in unilateral
cataract management include the need for early detection and intervention, consistent
compliance with refractive correction, and effective amblyopia therapy with occlusion of the
sound fellow eye. Because of the high rate of subnormal visual outcomes in eyes of patients
with unilateral infantile cataract, primary intraocular lens (IOL) placement was hypothesized
to improve outcomes.4

The Infant Aphakia Treatment Study (IATS) was a randomized multicenter clinical trial
designed to compare outcomes between children who had cataract surgery with primary IOL
insertion compared to those left aphakic, with a goal of maintaining the assigned treatment
arm protocol until age 5 years. 5 The results of the IATS revealed no difference in visual
outcomes between the groups at age 1 year, 4 ½ years, or 10 ½ years,6–8 but there was a
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higher rate of adverse events (most commonly, secondary opacities and need for additional
surgery) in eyes receiving primary IOL implantation.9 Prior to the age of 5 years, eyes
randomized to aphakia only had IOL implantation if the IATS Executive Committee
concluded that contact lens and spectacle correction could not be consistently maintained.
After age 5 years, patients were treated at the discretion of their primary ophthalmologist,
and children who were aphakic had the opportunity to have elective implantation of an IOL.

The purpose of this report is to describe outcomes for eyes that received secondary IOL
implantation, including a comparison of outcomes to aphakic eyes that did not undergo
secondary IOL implantation, and eyes that had primary IOL implantation in early infancy.

Methods
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The protocol and primary outcomes of the IATS have been previously published.5–8 In brief,
infants with a unilateral congenital cataract (≥ 3mm central opacity) undergoing surgery at
an age of 28 to 209 days were eligible for randomization to primary IOL implantation or
aphakia in the operative eye. The main exclusion criteria were persistent fetal vasculature
with stretching of ciliary processes or involvement of the optic nerve or retina, corneal
diameter <9mm, premature birth (<36 weeks gestational age), presence of a medical
condition that might interfere with later visual acuity testing, acquired cataract, or inability

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to maintain follow-up for 5 years. The study was approved by the institutional review boards
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of all participating institutions and in compliance with the Health Insurance Portability and
Accountability Act. The off-label research use of the Acrysof SN60AT and MA60AC IOLs
(Alcon Laboratories, Fort Worth, Texas) was covered by US Food and Drug Administration
investigational device exemption # G020021. The clinical trial is registered in
clinicaltrials.gov by Identifier NCT00212134.

Prior to age 5 years, secondary IOL surgery only occurred if the IATS Executive Committee
agreed that all other efforts to maintain refractive correction were exhausted. After age 5
years, refractive correction and the option for IOL insertion was left to the discretion of the
family and the provider.

Refractive error was assessed by retinoscopy every 3 months until age 4 ½ years, then at age
5 years and 10 ½ years. The primary outcome of visual acuity (VA) was assessed at age 4 ½
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years using HOTV optotypes, and at age 10 ½ years using the ETDRS research protocol.
Adverse events and secondary operations were recorded at each study visit. Data forms and
surgical records were used to collect information about details of secondary IOL surgery,
biometry, IOL calculations, targeted post-operative and early post-operative refractions.

Statistical analysis was performed using SAS version 9.4 (SAS Institute Inc., Cary, NC,
USA). Comparisons of visual outcomes were performed among eyes that had secondary
IOL, eyes that remained aphakic, as well as those with primary IOL implementation. Chi-
square tests were performed to compare proportions. Wilcoxon tests were used to compare
medians. Two-sample t-tests assuming unequal variances were used to compare means.

Results
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The IATS enrolled 114 infants, 57 in the aphakic group and 57 in the primary IOL group;
55/57 (96.5%) patients initially left aphakic were examined at the 10 ½ year study visit. Of
these 55 patients, 24/55 (44%) were known to have had IOL implantation (2 prior to the 4 ½
year visit due to contact lens intolerance, at 20 and 38 months of age). The median age at
secondary IOL surgery was 5.4 years (range, 1.7 to 10.3 years).

For secondary IOL surgery, biometry and surgical technique were by surgeon preference.
Biometry technique included optical coherence (5), immersion ultrasound (16), non-
specified ultrasound (1), or not specified (2). Keratometry (K) was recorded for 23 patients
and axial length (AL) for 22 patients. Mean K was 43.7 ±1.6 D (range, 40.9 to 47.3 D) in the
operative eye and 42.8 D ±1.7 D (range, 38.3 to 45.4 D) in the fellow eye. Mean AL was
21.4 ±1.0 mm (range, 19.6 to 23.9 mm) in the operative eye, and 22.6 ±0.9 mm (range, 20.9
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to 25.1 mm) in the fellow eye, with a mean AL difference of 1.3 ±1.2 mm. In 16/22 (73%)
cases the operative eye was >.5mm shorter than the fellow eye (7 cases by ≥1 to 2mm, and
in 5 cases by ≥2mm). Only 3 operative eyes were longer than the fellow eye, and 2 of these
had glaucoma. IOL calculation formulas used were the Holladay (14 cases), Sanders-
Retzlaff-Kraff theoretic (SRK/T, 4 cases), the SRK-II (1 case), and not specified in 4 cases.
The targeted post-operative refraction was typically low hyperopia (mean 1.1 ±1.3 D; range
−1.8 to 3.9 D).

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In 11 cases, the Soemmerring ring was opened, lens material aspirated, mechanical
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vitrectomy performed, and the IOL implanted within the capsular bag. In 12 cases, the IOL
was placed in the ciliary sulcus; in all 11 cases for which operative reports were available
anterior vitrectomy was performed, and the Soemmerring ring was debulked in 3 cases. A
foldable IOL was implanted in all but one eye, which had a polymethylmethacrylate
(PMMA) single piece IOL implanted in the ciliary sulcus due to limited capsular support.
The mean IOL power implanted was 26.5 D (median 26 D; range 20 to 34 D; Figure 1).

The early post-operative refraction was recorded for 17/24 cases. Mean Prediction error
(PE= Predicted Refraction - Actual Refraction) was 0.5 D ±1.1 D (range, −1.6 to 2.4 D).
Mean absolute PE was 1.0 ±0.7 D (range, 0.1 to 2.3 D).

At age 10 ½ years, the mean refraction in eyes receiving a secondary IOL was −2.75 ±3.1 D
(range, −11. 0 to 1.0 D), and the median refraction was −2.6 D. After excluding the 2
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children who had IOL implantation very early, the mean refraction was −3.2 ±2.7 D (range
−9.9 to 1.1 D). Figure 2 shows the distribution of refractions based on age at secondary IOL
surgery, with a trend for more variability in refraction for children who had earlier surgery.
However, when we performed analyses using age at secondary IOL surgery, IOL power
implanted, axial length at surgery, visual acuity, and refractive error in the fellow eye to look
for associations with more myopia at age 10 ½ years (in the group of 22 eyes with secondary
IOL after age 4 ½ years), no significant associations were found.

Figure 3 compares the early post-operative refraction after IOL implantation to the refraction
at 10 ½ years for 16 patients that had data for both visits and at least 6 months between the
IOL implantation and 10 ½ year visit. The mean myopic shift was −3.2 ±2.4 D (range −8.3
to 1.0 D), with a mean shift per year of −0.7 ±0.4 D (range, −1.4 to 0.2 D).
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The mean refraction for eyes undergoing secondary IOL implantation was significantly less
at age 10 ½ years than the mean refraction of eyes with primary IOL implantation (n=53,
mean −5.5 ±6.6 D, range −26.5 to 3.0 D; p=0.04); the median refraction in the secondary
IOL eyes was −2.6 D compared to −3.9 D in eyes with primary IOL (ns, p=0.3). High
myopia (>6D) at the 10 ½ year visit was noted in 17/53 (32% of eyes undergoing primary
IOL implantation, compared to 3/22 (13.6%) of eyes undergoing secondary IOL
implantation; 17/20 (85%) pseudophakic eyes with high myopia had undergone primary IOL
implantation.

There was no difference in the median log MAR VA in the secondary IOL group compared
to the group remaining aphakic at 10 ½ years of age (Table). The percentage of eyes
achieving 20/40 or better VA at age 10 ½ years was 22% in the secondary IOL group and
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29% in the group that remained aphakic. There were similar proportions of patients in each
group with ≥ 0.2 logMAR worsening in VA score between the 4 ½ year and the 10 ½ year
study visits (25% in the secondary IOL group and 26% in the contact lens group), and the
median change in these groups of eyes was not significantly different: median 0.6 logMAR
(25th percentile 0.4, 75th percentile 0.9 logMAR) in the secondary IOL group, and median
0.4 logMAR (25th percentile 0.3, 75th percentile 0.5 log MAR) in the aphakic group.

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Adverse events and other surgeries were compared between the secondary IOL group and
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the group of eyes that remained aphakic. No significant intraoperative complications were
noted on review of secondary IOL operative reports; one patient required re-operation for
removal of nylon sutures. Adverse events reported on 10 ½ year data forms (since the 5 year
visit) included one corneal abrasion in the aphakic/contact lens group, one case of transient
retained lens cortex and one case of lens re-proliferation requiring surgery in the secondary
IOL group. The number of patients diagnosed with glaucoma before and after age 5 years
was similar between the secondary IOL group (3 before, 0 after age 5 years) and the group
that remained aphakic (7 before, 3 after age 5 years).

Discussion
Implantation of an IOL is an anticipated event for many patients with infantile cataracts,
though the timing of implantation has been controversial. Primary IOL implantation does
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provide most of the refractive correction continuously, but infants require overcorrection
with spectacles as there is axial elongation and a large myopic shift in the first few years of
life. Most pediatric cataract surgeons prefer to leave infant eyes with residual hyperopia,
anticipating the myopic shift, but as evidenced by the eyes in the IATS, this refractive
change is variable and at times unpredictable. Since the IATS has shown there is no visual
advantage to primary IOL implantation for children < 7 months of age, investigators
recommended leaving these children aphakic if it is deemed likely that they could adhere
with contact lens correction until secondary IOL surgery could be performed.

Secondary IOL surgery techniques have been previously described,9–11 with good visual
outcomes and low complication rates. With uncomplicated primary cataract surgery in
infancy, a Soemmerring ring will develop in virtually all eyes, which can later be opened,
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reproliferated lens material aspirated, and then a foldable lens can be secured within the
capsular bag. If the capsular leaflets cannot be opened, there is usually sufficient residual
capsule for ciliary sulcus IOL placement (3-piece foldable or single piece PMMA). It is
uncommon to have insufficient capsular support requiring special techniques; all the
children in this study had capsular bag or ciliary sulcus IOL placement. No significant
intraoperative complications were noted in this cohort. However, it should be noted that
placement of an IOL within the capsular bag is preferred whenever possible, because
placement in the ciliary sulcus carries a higher risk of long-term iris chafing, chronic
inflammation, pigment dispersion, glaucoma, and late IOL dislocation.10, 12–15

Prediction error (PE) after pediatric cataract surgery is more variable than after adult cataract
surgery.16 This is due to many factors, including inconsistencies and inaccuracy of
ultrasound biometry (especially contact technique) on small soft eyes, formula errors (which
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can be exaggerated in small eyes), and variation in effective lens position. The mean
absolute PE for eyes in the IATS that had primary IOL implantation (and did not have
glaucoma) was 1.8D (± 1.3D),17 which is higher than the prediction errors reported for
pediatric cohorts that include older children. In the IATS, the Holladay 1 IOL calculation
formula was used for primary cataract surgery IOL power selection, which showed the
lowest median absolute PE (1.2D), but clinically similar results were calculated using the
SRK/T formula, which showed the lowest mean absolute PE (1.4 ±1.1D).18 Mean absolute

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PE for secondary IOL surgery in older pediatric cohorts has been shown to be similar to that
of primary IOL surgery, ranging from 0.9 to 2.1D.19–21 Even though most children were
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older than 5 years of age at the time of secondary IOL surgery, most eyes were still short
(<22mm), and use of a newer theoretical IOL calculation formula appropriate for short eyes
can help achieve the intended post-operative refraction. It should be noted that sulcus
placement of an IOL, particularly over a Soemmering ring, changes the effective lens
position, but formulas assume IOL placement within the capsular bag. Therefore, when
selecting an IOL for sulcus implantation, in order to achieve the desired post-operative
refraction, the IOL power selected should be .5 to 1.5D less than the power calculated by the
formula.22 While surgical technique, biometry, IOL type, and formula choice were at the
discretion of the surgeons for this cohort, we found the PE to be acceptable and similar to
other studies of pediatric patients.

Performing secondary IOL surgery at an older age can mitigate the uncertainly of
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unpredictable axial elongation that may occur between infancy and age 5 years. Two
important factors impacting axial elongation in very young children are development of
early glaucoma or secondary visual axis opacities requiring surgery. In the IATS, 13% of
eyes were diagnosed with glaucoma or glaucoma suspect by 1 year of age, and 16% of eyes
with primary IOL implantation developed a glaucoma-related adverse event.23,24 AL growth
in non-glaucomatous treated eyes was similar to that of the fellow eye (3.3 vs. 3.5 mm at 5
years, ns; 4.7 vs. 4.7 mm at 10 ½ years, ns), with no significant difference between the
aphakic group and the primary IOL group.25,26 However, the mean AL elongation was
significantly greater in eyes with glaucoma compared to those without glaucoma at 5 years
(5.7mm, P<0.0001 ) and 10 ½ years (7.3 mm, P<0.05). Additionally, eyes requiring
additional surgery for secondary opacification grew more than those that did not (3.8 vs. 2.7
mm by 5 years, P = 0.013; 3.7 vs 5.2 mm by 10 ½ years, P=0.05). Early surgery, glaucoma,
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and secondary opacities all contribute to increased rates of axial elongation and variability in
myopic shift. Even when excluding eyes with glaucoma, by 5 years of age IATS eyes with
primary IOL implantation before 6 months showed a mean refractive shift of 9D, with a
mean refraction of −2.53 D (and high variability with refraction range of +5D to −15D).27
Most publications about refractive change after pediatric cataract surgery exclude eyes with
glaucoma from analysis since glaucoma is a confounding variable, but this cannot be
ignored in clinical practice.

No associations were found with group final VA or changes in VA among eyes with
secondary IOL implantation compared to eyes remaining aphakic. The VA after IOL
implantation is not expected to be significantly different than the VA obtained with contact
lens or spectacle use; the main advantage of IOL implantation is improved uncorrected
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vision and continuous correction of refractive error. The decision to offer surgery should
take this into consideration, particularly for eyes known to have significant periods of
uncorrected aphakia when the contact lens is not being worn. This consideration applies
even to eyes with subnormal vision. Sensorimotor function should also be considered since
correction of refractive error by any method can improve ocular alignment. Although
primary IOL implantation was not shown to improve rates of strabismus or sensory
outcomes by 5 years in the IATS,28 secondary IOL implantation may benefit alignment
compared to an uncorrected refractive error. Undergoing a second surgery for IOL

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implantation introduces potential adverse events associated with anesthesia or surgery,

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though none were reported for this cohort.

Strengths of this study include well defined cohort with good long-term follow-up,
management by surgeons with expertise in secondary IOL surgery, and strong adherence to
protocol that required surgery to implant the secondary IOL be delayed until after age 4.5
years. A separate analysis of variables that may be predictive of the need for secondary IOL
is planned.

One limitation of this study is that there is inherent bias in the timing of and the selection of
eyes that had secondary IOL surgery. For example, we noted a higher rate of glaucoma in the
eyes that remained aphakic, which likely impacted decisions about IOL surgery. Also, even
though the distribution of eyes with good and poor vision was similar between this group
and the group that remained aphakic, there is lack of specific information about other
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diagnoses or anatomic findings that may not allow them to be secondary surgical candidates.
In practice, families often elect to proceed with surgery due to either intolerance to or the
financial burden of contact lens wear.

There are other limitations to consider when applying these findings to clinical practice.
First, the expertise and experience of the IATS surgeons may not fully represent the
experience of patients in a community setting. Secondly, these study families received
significant financial and emotional support with patching and contact lenses that may not be
available in other settings, enhancing their ability to comply with aphakic care and delay
secondary IOL surgery until after age 5 years. In other contexts, children may be much
younger at the time of secondary IOL implantation, introducing the possibility that the
adverse event rates of surgery could be higher, and the final residual refractive error greater
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than what was found for this cohort. Thirdly, a variety of other factors influence the decision
whether to proceed with and the timing of secondary IOL surgery outside of a clinical trial,
including surgeon and family preference, visual acuity, socioeconomic status, ability to pay
or insurance coverage for contact lenses or surgery. Finally, some children with unilateral
cataract would not have been eligible for enrollment into this study at all, either because of
baseline ocular features, neurodevelopmental or systemic diagnoses, or ability to follow-up
for 5 years. Eligibility for IOL implantation (whether primary or secondary) should be
considered on an individual basis.

Despite the above-mentioned limitations, this report suggests that there are refractive
advantages to delaying secondary IOL surgery until elementary school age, with a more
predictable refractive outcome and less chance of high myopia. When elective surgery is
done by an experienced surgeon after age 5 years, the complication rate is low, and there are
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far fewer adverse events than when IOL implantation is performed in infancy.

Supplementary Material
Refer to Web version on PubMed Central for supplementary material.

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Acknowledgments
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Funding/Support: Supported by National Institutes of Health Grants U10 EY13272, U10 EY013287, UG1
EY013272, UG1 EY025553, P30 EY026877 and Research to Prevent Blindness and the Norm Medow Foundation

Biography

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27. Weakley DR Jr, Lynn MJ, Dubois L, Cotsonis G, Wilson ME, Buckley EG, Plager DA, Lambert
SR; Infant Aphakia Treatment Study Group. Myopic Shift 5 Years after Intraocular Lens
Implantation in the Infant Aphakia Treatment Study. Ophthalmology. 2017 6;124(6):822–827.
[PubMed: 28215452]
28. Bothun ED, Lynn MJ, Christiansen SP, et al. Sensorimotor outcomes by age 5 years after
monocular cataract surgery in the Infant Aphakia Treatment Study (IATS). J AAPOS
2016;20(1):49–53. [PubMed: 26917072]
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J Cataract Refract Surg. Author manuscript; available in PMC 2022 February 01.
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Value Statement
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What Was Known

Secondary intraocular lens (IOL) surgery is an often anticipated event after cataract
surgery in infancy

Significant axial elongation occurs in early childhood, so large degrees of myopic shift
can occur in pseudophakic eyes

Post-operative myopic shift is thought to be minimized when IOL implantation is

performed after age 5 years

What This Paper Adds

In this multicenter study, half of the infants with unilateral cataract were randomized to
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surgery with contact lens correction of aphakia and delayed IOL implantation until age 5
years; less than half underwent IOL surgery by age 10 ½ years

IOL implantation was not correlated with differences in visual acuity outcome

Even with delayed IOL implantation, myopic shift was greater than anticipated in many
eyes
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 VanderVeen et al. Page 11

Synopsis
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After unilateral cataract surgery in infancy, delaying IOL implantation until age 5 years
results in less myopic shift, but still some cases of high myopia at age 10½ years.
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J Cataract Refract Surg. Author manuscript; available in PMC 2022 February 01.
 VanderVeen et al. Page 12
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Figure 1.
Intraocular lens (IOL) power vs. age at secondary IOL surgery. Abbreviations: n=sample
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size; SD = standard deviation; r = Pearson correlation coefficient. P-value is for a t-test for
the significance of the correlation.
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J Cataract Refract Surg. Author manuscript; available in PMC 2022 February 01.
 VanderVeen et al. Page 13
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Figure 2.
Refraction at age 10 ½ years vs. age at secondary IOL surgery. Abbreviations: n=sample
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size; SD = standard deviation; r = Pearson correlation coefficient. P-value is for a t-test for
the significance of the correlation.
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J Cataract Refract Surg. Author manuscript; available in PMC 2022 February 01.
 VanderVeen et al. Page 14
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Figure 3.
Change in refraction after secondary IOL surgery to 10 ½ year visit for 16 patients that had
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data for both visits and at least 6 months between the IOL implantation and 10 ½ year visit.
For each patient, a line is shown that connects the refraction after implantation and the
refraction at the 10 ½ year visit.
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 VanderVeen et al. Page 15

Table.

Log MAR visual acuity at 10 ½ years of age.

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Randomized group Status log MAR VA median VA 20/40 or VA >20/40 to VA 20/200 or

(range) better <20/200 worse
Aphakic Secondary IOL 0.9 (0.2–1.7) 5 (22%) 9 (39%) 9 (39%)
(n=23)*

Aphakic (n=31) 0.8 (0.1–2.9) 9 (29%) 8 (26%) 14 (45%)

Primary IOL (n=53) 0.9 (0.0–2.6) 11 (21%) 18 (34%) 24 (45%)

*
One subject did not have ETDRS VA data, so was excluded from VA analyses.
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J Cataract Refract Surg. Author manuscript; available in PMC 2022 February 01.