Journal of Pediatric Ophthalmology and Strabismus

Original Article 

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.

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):371–376.]

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.

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):371–376.]

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 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

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 measured 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-o'clock 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.

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. SRK-II formula was used to calculate IOL power. The target postoperative refraction was based on the patient's 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 13). 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.

(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 at the 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.

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 at the 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.

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.

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.

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.

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.

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 follow-up. 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 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.

Postoperative Complications at Last Follow-Up

Table 1:

Postoperative Complications at Last Follow-Up

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 ± 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 high-biocompatible 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 multi-piece IOLs.12 An incomplete fusion of the capsules occurs at and around the thick haptic–optic junction, resulting in a lack of bending of the posterior 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 optic–haptic 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, sharp-edged 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 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.

References

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Postoperative Complications at Last Follow-Up

ComplicationsNo. (%)
Posterior capsular opacification requiring/required surgical membranectomy4 (6.9%)
IOL deposits5 (8.62%)
Posterior synechiae5 (8.62%)
Haptic compression3 (5.1%)
Decentration of lens1 (1.72%)
Authors

From the Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

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

Received: May 28, 2014
Accepted: July 08, 2015

10.3928/01913913-20150929-15

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