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Outcome of a New Acrylic Intraocular Lens

Implantation in Pediatric Cataract


Jaspreet Sukhija, MD; Savleen Kaur, MD; Jagat Ram, MD

ABSTRACT
Purpose: To study the outcome of Hoya Clear Preloaded intraocular lens (IOL) (PC 60AD, AF Series; Hoya, Tokyo, Japan) implantation in children.
Methods: Children who underwent phacoaspiration
with primary posterior capsulotomy, anterior vitrectomy, and primary IOL implantation through a 2.8-mm
incision were observed prospectively. In all cases, attempts were made to implant the IOL into the capsular bag. Parameters noted were ease of implantation,
synechiae formation, IOL deposits, decentration of IOL,
visual axis obscuration, haptic compression, and ovalling of the rhexis. Intraoperative complications related
to the IOL were also recorded.

INTRODUCTION
Surgical techniques, biocompatible intraocular
lens (IOL) materials, and designs for the pediatric
eye have improved over the past few years. The types
and design of the IOL are considered important in
reducing the chances of posterior capsular opacification (PCO)1 and other complications.
The rate of PCO in pediatric eyes is high because
of the higher proliferative capacity of lens epithelial
cells in younger patients compared to older patients.
A search for newer IOL designs is ongoing to decrease
the rates of PCO.2 Acrylic lenses are proven to have

Results: This series comprised 58 eyes of 38 patients with


congenital/developmental cataract who underwent implantation of the Hoya IOL. Mean age of the patients was 3.27
2.69 years (range: 3 months to 8 years) and mean follow-up
was 24.5 9.13 months. Visual axis obscuration occurred in
4 eyes, posterior synechiae in 5 eyes, IOL deposits in 6 eyes,
haptic compression in 3 eyes, and IOL decentration in 1 eye.
Conclusions: The data suggest that implantation of
the Hoya IOL is a safe option in children undergoing
cataract surgery.
[J Pediatr Ophthalmol Strabismus. 2015;52(6):371376.]

lower rates of PCO as compared to silicone or polymethylmethacrylate (PMMA) IOLs in children.3,4


Recent studies have shown that single-piece acrylic
lenses are superior to a three-piece design as far as
perioperative and postoperative complications and
visual axis obscuration are concerned.5,6 On the other
hand, studies have shown there is no difference between the two.7,8 A sharp posterior optic edge, which
inhibits migration of lens epithelial cells behind the
IOL optic, has been shown to lower the incidence of
PCO. Acrylic IOLs with a sharp edge design lead to
significantly less PCO than round edge IOL.9

From the Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Submitted: May 28, 2014; Accepted: July 8, 2015
The authors have no financial or proprietary interest in the materials presented herein.
Correspondence: Jaspreet Sukhija, MD, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, sec 12, Chandigarh, India.
E-mail: jaspreetsukhija@rediffmail.com
doi: 10.3928/01913913-20150929-15

Journal of Pediatric Ophthalmology & Strabismus Vol. 52, No. 6, 2015

371

The Hoya IOL (Hoya Clear Preloaded, PC


60AD, AF Series; Hoya, Tokyo, Japan) is a foldable
sharp-edged hydrophobic acrylic posterior chamber
IOL. It is unique that, being a single-piece IOL, it
has PMMA haptics and a smaller overall diameter
as compared to other hydrophobic acrylic IOLs. In
this study, we evaluated the outcome of implantation of this IOL in children with congenital/developmental cataract. To our knowledge, this is the first
report in the literature.
PATIENTS AND METHODS
All pediatric patients younger than 8 years with
congenital/developmental cataract attending the pediatric ophthalmology clinic who underwent cataract
surgery with primary IOL implantation (Hoya Clear
Preloaded, PC 60AD, AF Series) were included. The
study period was from January 2010 to December
2010. Informed consent was obtained from the parent or guardian of the child and the study followed
the tenets of the Declaration of Helsinki. Inclusion criteria were patients diagnosed as having congenital/developmental cataract who had undergone
phacoaspiration with primary IOL implantation.
Eyes with traumatic cataract and secondary IOLs
were excluded. Patients with microphthalmos, coloboma, glaucoma, or any other ocular disease or those
with intraoperative complications such as zonular dialysis where the IOL could not be implanted or with
any posterior segment complications were excluded.
Preoperatively, all patients had complete ophthalmic examination. Data collected included the age at
surgery, laterality, sex of the child, birth-related complications, significant family history, type of cataract,
axial length preoperatively, type and power of IOL,
complications (if any), and postoperative retinoscopy/refraction with any PCO at the last follow-up
visit. IOL power was calculated on the basis of axial
length values derived from A-scan and keratometry by
a handheld keratometer. IOL power was implanted
with predicted error of +4.00 diopters (D) in patients
younger than 6 months, +3.00 D in patients 6 months
to 1 year, +2.00 D in patients 1 to 2 years, +1.00 D in
patients 2 to 3 years, and emmetropia in children older than 3 years. Objective streak retinoscopy was first
performed after surgery at an interval of 2 weeks when
no inflammation was documented and then repeated
at 6 weeks by a single optometrist. Best corrected visual acuity was recorded when a child was cooperative
at the last follow-up. Intraocular pressure was mea372

sured with a Perkins handheld applanation tonometer


(Clement Clark Co. Ltd., London, United Kingdom).
B-scan ultrasonography was performed in eyes where
a dense cataract precluded view of the fundus.
Surgical Technique

All surgeries were performed by the same surgeon (JS) under general anesthesia using standard
technique. Two limbal side port tunnels were made
at the 3- and 9-oclock positions using a 15 paracentesis knife. Trypan blue was injected to aid visualization of the anterior capsule in all cases. After
forming the anterior chamber with sodium hyaluronate, posterior limbal incision was made with
a 2.8-mm keratome knife and continuous anterior
capsulorhexis of approximately 5 mm in diameter
was performed with Utrata forceps. Aspiration of
the lens was accomplished using an automated
handpiece. Primary posterior capsulotomy of approximately 3 to 3.5 mm and anterior vitrectomy
was performed by the anterior route through the
same limbal side ports. The same IOL implantation
(Hoya Clear Preloaded, PC 60AD, AF Series) was
performed in all patients.
After injecting an ophthalmic viscoelastic device
to inflate the bag, viscoelastic was injected through
an infusion port in the injector up to a pre-drawn
mark so that the IOL was entirely immersed in the
ophthalmic viscoelastic device. The IOL was slowly
advanced with the slider until the slider could go no
further, making sure that the leading haptic was extended forward. The plunger was gently pushed forward until it engaged the threads. The plunger was
rotated clockwise to release the IOL. The leading
PMMA haptic was directed under the capsulorhexis
margin and the IOL was injected completely from
the injector system into the eye. The trailing haptic
was dialled into the bag with a Y-hook.
In all of the patients, in-the-bag IOL implantation was attempted. Sulcus implantation was
performed in cases when there was anterior capsulorhexis extension and optic capture in cases with
large posterior capsular tear.
The residual ophthalmic viscosurgical device
was removed and the incisions closed. All patients
were treated postoperatively with betamethasone
eye drops every hour for 1 week followed by slow
tapering over the next 4 weeks. Topical moxifloxacin
was given four times a day for 1 week postoperatively. Homatropine drops were given for 1 week.
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Figure 1. (A) The 10 magnified Hoya Clear Preloaded intraocular lens (PC 60AD, AF Series; Hoya, Tokyo, Japan) well centered in the right eye
of a 4-year-old child atthe 1-year follow-up. (B) The 16 magnified view shows a clear visual, with the presence of a round posterior capsulorhexis. There is proliferation of lens epithelial cells at the margin of the posterior capsulorhexis in the form of an Elschnig pearl cluster.

A record of the follow-up visits was made at 1


day, 1 week, 1 month, and 6 months. At all of the
follow-up visits, patients were observed at the slit
lamp or under anesthesia for younger children.
Statistical Analysis

Statistical analyses were performed using SPSS


software (SPSS, Inc., Chicago, IL). A P value less
than .05 was considered statistically significant. Descriptive analysis was performed on all patients and
a record of both eyes was kept. Regression analysis
was performed to find out if any factor (age of the
patient, site of IOL, and time since cataract surgery)
correlated with the incidence of complications.
RESULTS
Sixty eyes of 40 children underwent preloaded
Hoya IOL implantation for congenital/developmental cataract. Two children did not complete the
1-year follow-up and therefore 58 eyes of 38 children were included for analysis. There were 11 girls
and 27 boys. Mean age of the patients at the time of
surgery was 3.27 2.69 years (range: 3 months to
8 years). There were 14 patients (25 eyes) younger
than 1 year, 4 patients (7 eyes) between 1 and 2 years,
11 patients (16 eyes) between 2 and 5 years, and 9
patients (10 eyes) older than 5 years. Two patients
were preterm birth and two had positive TORCH
titres. No patient had a positive family history. The
left eye was operated on in 24 cases and the right eye
in 34 cases. Six patients had nystagmus and 11 had

strabismus preoperatively. Five eyes had a lamellar


cataract and 3 eyes had persistent hyperplastic primary vitreous. The remaining eyes had total white
cataract.
Mean axial length of the patients was 20.6
1.87 mm (range: 18.04 to 25.93 mm). Mean IOL
power was 25.30 3.30 D (range: 14.00 to 30.00
D). All patients underwent A-scan biometry. SRKII formula was used to calculate IOL power. The
target postoperative refraction was based on the patients age and fellow-eye status.
In all of the eyes, anterior capsulorhexis with lens
aspiration, posterior capsulotomy, and anterior vitrectomy were performed with implantation of the same
IOL (Figures 1-3). Anterior capsulorhexis was extended in 3 eyes but posterior capsulotomy was performed
in all cases. The IOL was implanted in the bag in 46
eyes and in the sulcus in 7 eyes. Optic capture with
haptics in the ciliary sulcus was performed in 5 eyes.
No other intraoperative complications were noted.
On the first postoperative day, all eyes had a
well-formed anterior chamber. No cases of hyphema,
wound leakage, retinal detachment, or endophthalmitis were observed. Fibrinous inflammation was
observed in 4 eyes that cleared at subsequent followup. Raised intraocular pressure was found in one
eye, which decreased with topical medicine. Table
1 details the complications noted on subsequent examinations on slit lamp or under anesthesia at the
last follow-up. From regression analysis, the age of
the patient was found to be inversely related to the

Journal of Pediatric Ophthalmology & Strabismus Vol. 52, No. 6, 2015

373

Figure 2. Intraocular lens (IOL) deposits seen in a 2-year-old child


with the Hoya Clear Preloaded IOL (PC 60AD, AF Series; Hoya, Tokyo, Japan) at the 8-month follow-up. There is no posterior capsular opacification and the IOL is well centered in the bag.

TABLE 1

Postoperative Complications
at Last Follow-Up
Complications

No. (%)

Posterior capsular opacification requiring/required surgical membranectomy

4 (6.9%)

IOL deposits

5 (8.62%)

Posterior synechiae

5 (8.62%)

Haptic compression

3 (5.1%)

Decentration of lens

1 (1.72%)

IOL = intraocular lens

number of complications (P = .001). At the mean


follow-up of 24.5 months, there were no cases of
endophthalmitis, glaucoma, or retinal detachment.
There was one child with ocular hypertension controlled with topical medications. Four eyes needed a
membranectomy for PCO, of which 2 eyes had persistent fetal vasculature and 2 eyes had IOL in the
sulcus. Haptic compression was seen in 3 eyes. These
children were younger than 6 months.
At the last follow-up (mean: 24.5 9.13
months), the mean spherical equivalent was +1.02
3.49 D. The mean numerical error defined as the
mean difference between the measured spherical
equivalent error and the predicted error was 0.12
374

Figure 3. Postoperative photograph of a 2-year-old child at 13


months postoperatively, showing proliferation of lens epithelial
cells reaching up to the capsulorhexis margin; however, the visual
axis remained clear.

1.14 (P = .34) at 2 weeks postoperatively. The mean


logMAR visual acuity was 0.35 0.16.
DISCUSSION
Primary IOL implantation in children is becoming increasingly common considering the age
of the child. When selecting IOLs for children, we
need to find a biocompatible material for the pediatric eye with adequate size and power.
Due to the capsular and inflammatory responses with PMMA IOLs, surgeons now use highbiocompatible foldable acrylic lenses, which allow
small-incision surgery with decreased postoperative inflammation, and astigmatism.3,4,8 Dahan and
Drusedau10 reported good results with posterior
chamber IOLs having an overall diameter of 10.5
mm and an optic of 5.5 mm. Hutchinson et al.11
reported that the flexible haptics of the acrylic IOL
allow implantation of an adult-sized lens into an
infant eye with minimal trauma and only moderate
capsular bag distortion.
Although patient variables and technique of
surgery may influence the outcome of surgery, tremendous innovations in IOL technology have led to
the advent of the single-piece IOL with sharp edges.9
Although these are easier to use with injector systems and cause no haptic kinking or compression,
the haptics tend to be much thicker than multipiece IOLs.12 An incomplete fusion of the capsules
occurs at and around the thick hapticoptic junction, resulting in a lack of bending of the posterior
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capsule around the posterior optic edge at this site.


These IOLs extend directly from the posterior optic
surface, leaving a section of the circumference of the
optic interrupted (ie, without a sharp edge). Some
studies report more PCO in eyes implanted with
one-piece IOLs compared to three-piece models,
because the optichaptic junction is the primary site
of initiation or scaffold for lens epithelial cells to migrate behind the IOL optic, resulting in PCO.13,14
The Hoya IOL that we used is a foldable, sharpedged hydrophobic acrylic posterior chamber IOL
that is preloaded in a disposable injector. The sharp,
square edge inhibits the migration of lens epithelial cells, lowering the incidence of PCO. This IOL
optic has a much sharper edge than other acrylic
hydrophobic foldable IOLs.15 Thus, the Hoya AF-1
PC60AD model has an advanced step edge, with
a 360 continuous smooth edge in addition to the
sharp edge. This allows the lens to adhere more
tightly to the posterior capsule after insertion and
thereby reduce PCO.
The IOL is unique because of its one piece-two
material design. It has cross-linked blue PMMA
haptics bonded to an ultraviolet light-absorbing
high refractive index biconvex acrylic optic in a single piece. The haptics are angulated at 5, overcoming the problem of lack of bending of posterior capsule seen in other single-piece IOLs to some extent.
The haptics, being of a different material, decrease
the chance of adherence of the haptic to the optic
and also enhance visualization of the haptic tip. The
PMMA haptics in this IOL incorporate features
of both a single-piece and three-piece IOL. The
acrylic optic decreases the risk of intense inflammation, similar to other hydrophobic acrylic optic
IOLs. The optic has a diameter of 6 mm and the
overall length of the IOL is 12.5 mm, which is less
than other acrylic single-piece IOLs. This smaller
size could be advantageous for the pediatric eye. In
children where a primary posterior capsulorhexis
(PPC) is indicated, this IOL has the advantage of
safe placement in sulcus/optic capture in cases with
inadvertent extension of PPC or in cases where a
large PPC is attempted.
Although we did not study the property of glistening in our study, the Hoya IOL has been previously reported to have almost no glistening,12 leading to a better optical quality of these IOLs. The
lathe cut during manufacturing gives the IOL a
smooth surface, reducing the scattering of light.

The Hoya IOL has previously been implanted in


adults.12,14 It has been reported that the newer model
of the Hoya IOL has a much sharper square edge than
the Alcon AcrySof SN60WF IOL Alcon Laboratories, Fort Worth, TX).12,16 The functional results are
satisfying and comparable to results gained with other
aspheric IOLs with minimum decentration and tilt
along with ability to compensate corneal spherical aberration.17,18 The reported rate of laser capsulotomy 2
years after surgery is 4.3% with the newer Hoya IOL.14
A thorough search of the literature did not reveal any study on the use of the Hoya IOL in children. We experienced easy implantation and good
centration with minimal tissue trauma. The rate of
complications in our study was minimal. Decentration occurred in only one eye and IOL deposits or
significant inflammation in few eyes.
Visual axis opacification after congenital cataract
surgery is of great concern because it leads to amblyopia if not treated in time. We observed visually
significant posterior capsular opacification in 6.9%
eyes. The rates are lower compared to a single-piece
acrylic AcrySof IOL (11.9%, 30.3%) in a larger series19,20 and three-piece AcrySof IOL (21%)21 in a
smaller study. Ram et al.22 reported a PCO rate of
13.9% in one of the largest studies to date. This was
despite primary PPC and anterior vitrectomy having
been performed in these eyes where a AcrySof hydrophobic IOL was implanted. Trivedi et al.23 showed an
incidence of 25% with the three-piece AcrySof IOL
and 23% with the single-piece AcrySof IOL in infants who underwent phacoaspiration with PPC and
IOL implantation. Although the rate of PCO also
increases in children operated on at a younger age,
the promising results in our study indicate that the
design of the Hoya IOL could be an additional factor in low incidence of PCO in our study. We had
a mean follow-up of 24 months and the maximum
rates of visual axis obscuration were found in the first
year after surgery.
We observed posterior synechiae in 8.6% eyes
and cell deposits in 5 eyes at the 1-year follow-up. A
previous study by Trivedi and Wilson19 found posterior synechiae and cell deposits in 7 eyes (11.9%).
In a study of 59 eyes, Kugelberg et al.20 did not find
posterior synechiae but did observe inflammatory
cells on the IOL in 7 eyes. Hence, the rate of inflammation was equivalent to other acrylic IOLs.
The rate of complications is also higher in
younger children11,23 (hence more complications

Journal of Pediatric Ophthalmology & Strabismus Vol. 52, No. 6, 2015

375

in our patients younger than 7 months) and related to a specific type of cataract (more complications in persistent fetal vasculature24). Because
multiple confounders can affect PCO and inflammation, perhaps larger trials with a similar subset
of patients undergoing surgery with implantation of
different IOLs could help in better understanding
of the effect of the material and design of the IOL
in pediatric cataract surgery. Our study was an unmasked observational study with no control group.
The Hoya IOL is a three-piece design with the dual
advantage of a single-piece (lower PCO, inflammation) and three-piece (sulcus fixation/capture) IOL.
We achieved good surgical outcomes with the use of
the Hoya IOL in pediatric eyes and therefore recommend them as a viable option in children undergoing cataract surgery.
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