Bag-in-the-lens intraocular lens implantation in the pediatric eye

ARTICLE

Bag-in-the-lens intraocular lens implantationin the pediatric eye

Marie-Jose Tassignon, MD, PhD, FEBO, Ilse De Veuster, MD, Daisy Godts, CO, Dragica Kosec, MD,Karl Van den Dooren, MD, Laure Gobin, PhD

PURPOSE: To study the efficacy, safety, and feasibility of implantation of a bag-in-the-lens intraoc-ular lens (IOL) in children and babies.

SETTING: Departments of Ophthalmology, University Hospital, Antwerp, Belgium, and the Univer-sity Hospital, Ljubljana, Slovenia, and a private ophthalmology practice, Oudenaarde, Belgium.

METHODS: Thirty-four eyes of 22 children had implantation of a bag-in-the-lens IOL. The agesranged from 2 months to 14 years. Congenital cataract was present in 26 eyes, and persistent fetalvasculature (PFV) was concomitantly present in 4 eyes. Fifteen patients had bilateral cataract, and6 had unilateral cataract.

RESULTS: In 3 eyes, the IOL could not be properly implanted. In these cases, secondary interven-tion was necessary because of early posterior capsule opacification. The mean postoperative fol-low-up was 17.45 months G 17.12 (SD) (range 4 to 68 months). None of the children exceptthose presenting with PFV had anterior vitrectomy during surgery. The optical axis remained clearduring the follow-up in all patients who had successful IOL implantation.

CONCLUSIONS: The bag-in-the-lens implantation technique in children and babies was safe andkept the visual axis clear after cataract surgery. In the near future, 4.0 or 4.5 mm IOLs will be avail-able that may improve the success rate of IOL implantation in the small eyes of babies.

J Cataract Refract Surg 2007; 33:611–617 Q 2007 ASCRS and ESCRS

The conventional intraocular lens (IOL) implantationtechnique, also called the lens-in-the-bag implanta-tion, consists of inserting the IOL in the capsular bag(Figure 1, A). This causes a large area of contact be-tween the IOL biomaterial and capsular bag. The

Accepted for publication December 19, 2006.

From the Department of Ophthalmology, University Hospital Ant-werp (Tassignon, De Veuster, Godts, Gobin), Antwerp, and a privatepractice (Van den Dooren), Oudenaarde, Belgium; the Departmentof Ophthalmology, University Hospital Ljubljana (Kosed), Ljubljana,Slovenia.

Dr. Tassignon has a proprietary interest in the bag-in the-lensconcept (U.S. Patent 6,027,531 and E.U. Patent 009406794.PCT/120268 licensed to Morcher, Germany). No other author hasa financial or proprietary interest in any material or methodmentioned.

Corresponding author: M.J. Tassignon, MD, PhD, FEBO, UniversityHospital Antwerp, Department of Ophthalmology, Wilrijkstraat 10,B-2650 Edegem, Antwerp, Belgium. E-mail: [email protected].

Q 2007 ASCRS and ESCRS

Published by Elsevier Inc.

capsular bag response, described as a foreign-body re-action of lens epithelial cells (LECs) to the IOL bioma-terial, results in stimulation of LECs, causing posteriorcapsule opacification (PCO).1

The bag-in-the-lens technique uses a new IOL de-sign and a modified implantation method; the IOL op-tic incorporates plane haptics of an elliptical shape. Inthe bag-in-the-lens technique, the anterior and poste-rior capsules are placed in the IOL’s groove after a cap-sulorhexis of the same size is created in both capsules(Figure 1, B). The continuous groove is defined by theanterior and posterior haptics, which are perpendicu-larly oriented to each other to ensure IOL stability(Figure 2). To insert the lens properly, the anterior cap-sulorhexis and posterior capsulorhexis must be thesame size.

Clinical trials were conducted between December1999 and December 2004. The surgical technique wasmodified during this evaluation period to improveand facilitate the surgical procedure. The bag-in-the-lens IOL was approved by the Belgian Social Securityin December 2004 and has been used routinely since. Apoly(methyl methacrylate) anterior capsulorhexis ring

0886-3350/07/$dsee front matter 611doi:10.1016/j.jcrs.2006.12.016

mailto:[email protected]

mailto:[email protected]

612 PEDIATRIC BAG-IN-THE-LENS IOL IMPLANTATION

caliper2 (U.S. patent pending) was designed and man-ufactured by Morcher to allow more accurate creationof the capsulorhexis.

The first clinical results of this lens were excellent3;the capsule remained clear in all 100 adult eyes 12 to64 months after surgery.4,5 These results exceed thebest results obtained with any other IOL implantedin the bag.6 We report the results of implantation ofthis new IOL design using a modified technique in pe-diatric eyes.

PATIENTS AND METHODS

The bag-in-the-lens IOL was implanted in 34 eyes of 22 children. All34 eyes had a posterior capsulorhexis; no eye except 4with persistentfetal vasculature (PFV) had anterior vitrectomy. All eyes with PFVhad anterior vitrectomy.

All patients were operated on using general anesthesia with thepupils dilated by cyclopentolate drops and a dilution of 1:1000adrenaline. The incision side was temporal in all eyes but limbal insmall children and clear corneal in older children.

Before the ring caliper was inserted, the anterior chamber wasfilledwith sodiumhyaluronate 2.3% (Healon5). After the ring caliperwas positioned on top of the anterior capsule and centered along thefirst and third Purkinje reflexes, additional Healon5 was injected un-til ameniscuswas seen in the anterior surface of the lens capsule. Theanterior capsule was first punctured with a 30-gauge needle, afterwhich an anterior continuous curvilinear capsulorhexis (ACCC)was created with an Ikeda 30-degree angled microforceps (FR2268,Eyetech). The lens material was aspirated in the irrigation/aspira-tion mode using the phaco probe. After all lens material was re-moved, the LECs were kept in place and the capsular bag was leftcollapsed. Healon5 was put on top of the remaining anterior capsuleto restore the anterior chamber.

The posterior capsule was then punctured with a 30-gauge nee-dle, and sodium hyaluronate 1% (Healon) was injected throughthe hole to push back the anterior vitreous face and lift the posteriorcapsule at the level of the ACCC. A posterior continuous curvilinearcapsulorhexis (PCCC) was then created with the Ikeda microforcepsby tearing the posterior capsule along the edge of the ACCC. Thebag-in-the-lens IOL was injected through a 2.8 cartridge (Medicel)and the lens positioned on top of the anterior capsule, with the lon-gest axis of the posterior haptic at the 6 o’clock and 12 o’clock posi-tions. The posterior haptic was then gently pushed with the Healonneedle behind the posterior capsule at the 6 o’clock position in lefteyes and the 12 o’clock position in right eyes until both the anteriorand posterior capsules were engaged in the IOL groove. Insertion ofthe bag-in-the-lens IOL was completed by exerting gentle right-to-left movements on top of the optic until the insertion of both capsular

Figure 1. A: Schematic drawing of lens-in-the-bag IOL implantation.B: Schematic drawing of the bag-in-the-lens IOL implantation.

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blades over 360 degrees. In eyes with PFV, an anterior vitrectomywas performed until the vascular cord was retracted.

Immediately before surgery, the IOL power was calculated usingthe SRK/T formula based on the refraction and keratometric valuesobtained from the Retinomax autorefractor (Righton). The A-con-stant was 118.2. For children younger than 1 year 6.00 diopters (D)and for children between 1 year and 2 years 4.00 D were deductedfrom the calculated IOL power as proposed by Jacobi et al.7 and Tro-mans et al.8 Emmetropia was the target for children 2 years andolder.

When possible, postoperative intraocular pressure (IOP) wasmeasured using the Perkins, Tono-Pen, or Schiotz method.

Postoperative visual training programs started immediately aftersurgery, especially in children with unilateral cataract.

RESULTS

Table 1 shows the number of eyes operated on, thecause and type of cataract, the age at surgery, andthe postoperative follow-up. The mean age of the chil-dren was 6 years 2 months G 4 years 10 months (SD)(range 2 months to 14 years). The mean postoperativefollow-up was 17.45 G 17.12 months (range 4.0 to 68.8months).

Figure 2. Top: Schematic drawing of the bag-in-the-lens IOL showsthe main circular central optic surrounded by the haptic. The 2 hap-tics are oriented perpendicularly to each other to ensure optimumlens stability. Below: A side view shows the characteristic groove inwhich both lens capsules are positioned (1 Z optic; 2 Z groove;3 Z oval posterior haptic; 4 Z oval anterior haptic; 5 Z positioningholes, optional).

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613PEDIATRIC BAG-IN-THE-LENS IOL IMPLANTATION

Table 1. Number of eyes operated on, underlying cause of cataract, age at surgery, and postoperative follow-up.

Pt Operated Eye Pathology Age at Surgery Postop Follow-up (Mo)

1 OD Nuclear fetal cataract 4 y 68.8OS Nuclear fetal cataract 4 y 63.8



4 OD Posterior polar cataract C PFV 7 mo 29.15 OD Nuclear fetal cataract 3 y 31.8

OS Nuclear fetal cataract 3 y 32.06 OD Posterior polar cataract 7 y 8.77 OD White cataract C PFV 15 mo 13.88 OD Posterior polar cataract 8 y 30.1

OS Posterior polar cataract 9 y 20.49 OD Posterior polar cataract 12 y 8.5

OS Posterior polar cataract Not yet operated10 OD Diffuse punctiform cataract 12 y 14

OS Diffuse punctiform cataract 12 y 13.911 OD Zonular cataract 13 y 8.0

OS Zonular cataract 13 y 7.012 OS Polar fetal cataract 2 y 14.713 OD Diffuse punctiform cataract 14 y 12.0

OS Diffuse punctiform cataract 14 y 12.014 OD Posterior polar cataract 13 y 5.5

OS Posterior polar cataract 13 y 5.815 OS Radiotherapy-induced cataract 7 y 4.016 OD Anterior polar cataract C PFV* 5 4.517 OD Posterior polar cataract C PFV 4 y 5.018 OD Trisomy 21 associated Not yet operated

OS Trisomy 21 associated 6 y 7.019 OD Spherophakia C dysgenesis AC† 3 6.2

OS Spherophakia C dysgenesis AC† 3 y 5.920 OD Nuclear fetal cataractz C dysgenesis AC 5 mo 8.0

OS Nuclear fetal cataractz C dysgenesis AC 5 mo 8.021 OD Nuclear fetal cataract* 2 mo 5.0

OS Nuclear fetal cataract* 2 mo 5.022 OD Posterior polar cataract 10 y 5.0

OS Posterior polar cataract 10 y 5.0

AC Z anterior chamber; PFV Z persistent fetal vasculature; Pt Z patient*Successful surgery in a second attempt†Megalocornea (13.5 mm) with multiple anterior synechias and embryotoxonzSulcus insertion because of microcornea (8.5 mm � 9 mm both eyes) and shallow anterior segment

Congenital or developmental cataract as the only oc-ular pathology was present in 26 eyes and PFV wasconcomitantly present in 4 eyes. One child developeda cataract after orbital radiotherapy. One child had cat-aract combined with trisomy 21, and 2 had cataractwith other dysgenesis of the anterior segment (1 mi-crocornea of 8.5 to 9.0 mm and 1 macrocornea greaterthan 13.5 mm). Bilateral cataract was present in 15 pa-tients (of which 13 had surgery in both eyes) and uni-lateral cataract in 6 patients.

In 3 of the 34 eyes, the bag-in-the-lens IOL could notbe properly implanted. In these eyes, only the anterior


capsule was inserted in the IOL groove in both eyes of21 patients (2.5 months) and in the eye of 16 patients(5.0 months). The bag-in-the-lens IOL was placed inthe sulcus in the microphthalmic eye of patient 21(bag-in-the-lens IOL had same diameter as the anteriorchamber; ie, 8.5 mm).

Table 2 shows the preoperative and postoperativeoptical and refractive parameters as well as theIOP and range of accommodation at the last post-operative follow-up visit. The mean postoperativespherical equivalent was �0.10 G 2.20 D (range�4.50 to C5.00 D) for a mean target refraction of



Table 2. Preoperative and postoperative optical parameters and refractive parameters, postoperative IOP, and range of accommodation atthe last follow-up visit.

PtOpEye

PreopBVCA

AL(mm)

PreopK (D)

Preop CornAstig (D)

PostopUCVA

PostopBCVA

PostopSE (D)

Postop CornAstig (D)

IOP(mm Hg)

AccommRAF (D)

1 OD 0.4 21.5 43.0 0.4 0.4 1.0 2.5 �1.0 15 4.0OS 0.4 21.0 42.0 0.4 0.4 1.0 3.5 �0.5 15 4.0

2 OD 0.2 22.6 43.7 1.8 0.4 0.8 �0.9 �1.3 19 5.0OS 0.2 22.4 43.8 2.1 0.3 0.5 �1.8 �2.0 19 5.0

3 OS d 19.5 d d d d d d d d

4 OD d d d d 0.07 d �2.6 �3.3 d d

5 OD 0.2 19.9 47.9 3.4 d 1.2 0.4 �2.3 19 d

OS 0.1 18.6 47.6 4.1 d 0.8 1.5 �3.0 19 5.06 OD 0.1 22.5 41.2 1.3 0.07 d �0.9 �0.8 16 d

7 OD d 19.9 d d d 0.1 d d 15 4.08 OD 0.1 24.2 44.1 1.0 0.2 1.0 �4.5 0.0 17 3.5

OS 0.1 23.9 44.3 0.2 0.5 1.0 �2.5 0.0 16 3.09 OD 0.3 23.0 44.8 1.6 0.2 1.2 �1.5 �2.0 13 3.0

10 OD 0.2 20.7 43.9 0.5 0.8 1.0 �0.8 0.0 19 3.0OS 0.3 20.9 44.1 0.7 0.8 1.0 �0.5 �1.0 19 3.0

11 OD 0.2 25.0 41.6 1.7 0.6 1.0 �1.0 �2.0 17 d

OS 0.3 25.0 42.0 2.2 0.7 1.0 �1.0 �2.0 17 d

12 OS d 21.5 d d d d d d 18 6.013 OD 0.2 24.1 42.9 1.4 0.8 0.8 0.0 0.0 21 3.0

OS 0.1 24.4 43.4 1.7 0.9 0.9 0.0 0.0 14 12.014 OD 0.3 22.6 47.9 3.1 0.7 0.8 �1.0 �1.0 16 d

OS 0.3 22.0 48.4 2.8 0.7 0.0 0.0 17 d

15 OS 0.4 23.4 40.4 0.6 0.8 0.0 0.0 11 2.516 OD d 20.5 46.0 0.0 d d 1.3 �2.0 16 d

17 OD 0.1 20.0 46.4 2.4 d 0.3 d d 11 d

18 OS d 22.2 45.8 0.0 d d d d d d

19 OD 0.2 21.8 43.4 2.5 d 0.5 5.0 d 20 d

OS 0.2 21.7 43.2 2.9 d 0.5 3.5 d 30 d

20 OD d 18.4 41.2 1.9 d d C6 �3 19 d

OS d 18.4 41.2 2.1 d d C3 �2.75 13 d

21 OD d 18.5 44.4 1.4 d d d d d d

OS d 18.0 44.8 1.5 d d d d d d

22 OD 0.15 21.52 47.4 1.8 0.4 0.7 �1.25 �1.50 15 d

OS 0.15 21.58 47.5 2.65 0.8 0.8 0 0 15 d

Accomm Z accommodation; AL Z axial length; BCVA Z best corrected visual acuity; Corn Astig Z corneal astigmatism; IOP Z intraocular pressure; K Zkeratometry; Op Eye Z operated eye; Pt Z patient; RAF ZRoyal Air Force test for measuring accommodation; SE Z spherical equivalent; UCVA Z uncor-rected visual acuity

�0.12 G 0.60 D. This led to the conclusion that the A-constant of 118.2 currently used for adults is also suit-able in children (axial length, mean 21.6 G 2.0 mmand range 18.0 to 25.0 mm; keratometry, mean44.30 G 2.30 D and range 40.40 to 48.40 D). Postop-erative accommodation, measured with the RoyalAir Force test, was relatively large, with a mean of4.30 G 2.50 D (range 2.50 to 12.00 D); this allowedmost children to read without spectacles. Postopera-tive astigmatism remained statistically unchangedfrom preoperatively.

In all patients, the postoperative images showsa clear optical zone, no vitreous reaction, and a quietanterior chamber (Figure 3, A and B).


During the follow-up period, 6 eyes required a sec-ond surgical procedure.One eye (patient 3) had adrop-ped IOL 1 week after surgery because of oversizedanterior and posterior capsulorhexes (before the intro-duction of the ring caliper). Another eye (patient 13)had a posttraumatic luxated IOL into the anteriorchamber 1 week postoperatively. The IOL was reposi-tioned and remained stable thereafter.

Patient 16 required a posterior approach to reposi-tion the IOL 3 months after surgery. The anterior cap-sule only was inserted in the IOL groove at theprimary surgery. Pars plana vitrectomy allowed com-pletion of dissection of the PFV and proper positioningof the posterior capsule in the IOL groove.



Figure 3. Postoperative results of bag-in-the-lens IOL at 8 months (A) and 41 months (B).

A secondary pars plana approach to position theposterior capsule in the IOL groove was necessary inboth eyes of patient 21. Repositioning the IOL was jus-tified because of the appearance of visual axis reprolif-eration 3 months after surgery. Using this approach,the posterior capsule was successfully placed in thelens groove.

Iris capture occurred in 1 eye of patient 19. This childpresented preoperatively with iris synechias, whichwere released at the primary surgery. The secondsurgery consisted of releasing the iris capture anddeepening the iridocorneal angle using an ophthalmicviscosurgical device (Healon5).

Additional antiglaucoma treatment was needed inpatient 19, who had concomitant anterior segmentdysgenesis. Glaucoma surgery will be mandatory inthe near future in this case. One patient (13) neededmedical antiglaucoma treatment.

DISCUSSION

Based on its specific design, the bag-in-the-lens IOLlimits contact between the capsular bag and IOLmate-rial to the merging edges of the anterior capsulorhexisand posterior capsulorhexis at the level of the lensgroove. This limited contact reduces the capsular re-sponse, as described by Abela-Formanek et al.1 Thesecond theoretical advantage of this implantationtechnique is the entrapment of the LECs within the re-maining peripheral capsule, reducing the risk fortransforming the LECs into fibroblast or myofibro-blasts triggered by inflammatory mediators releasedduring surgical stress. The LECs remain in their phys-iological condition within the lens capsule; thus, wehypothesized this would favor postoperative trans-parency and flexibility of the lens capsule. The thirdtheoretical advantage of the bag-in-the-lens techniqueis that it avoids anterior vitrectomy if PFV is not pres-ent. Our study’s results corroborate these theoreticalassumptions.

Posterior capsulorhexis is widely accepted today inpediatric cataract surgery. Zetterstrom et al.9 recom-mend creating a posterior capsulorhexis in all


children. A posterior capsulorhexis seems to lowerthe risk for visual axis reproliferation, as reported inmany studies.10–12

In a series of studies in which children had ACCC,PCCC, and anterior vitrectomywithout IOL implanta-tion, the rate of PCO was 16.67%,13 50.00%,14 and29.41%.15 In combinationwith pars plana capsulotomyand anterior vitrectomy, visual axis reproliferationwas reduced to 9.2%.16 Plager et al.17 report a signifi-cant difference in the visual axis reproliferation ratewith or without IOL implantation in children youngerthan 6 months; the rate was 80% in the pseudophakicgroup and 12% in the aphakic group. The type of IOLdoes not play a significant role in visual axis reprolifer-ation, according to Ram et al.11 In a review of the liter-ature, Guo et al.18 found that combiningACCC, PCCC,and anterior vitrectomy significantly reduced the vi-sual axis reproliferation rate. Vasavada et al.19 founda visual axis reproliferation rate of 37.5% in 14 eyes ofchildren 2 years or older who had PCCC only and of6.7% in 15 eyes that hadPCCCandanterior vitrectomy.

Optic capture of the IOL has been reported to pre-vent visual axis reproliferation after cataract extractionin children.20 In a prospective study of 41 eyes of chil-dren older than 5 years, Vasavada et al.21 advocatecontinuing to combine optic capture with anterior vit-rectomy to guarantee a clear visual axis. In a retrospec-tive study, Argento et al.22 found that IOL opticcapture without vitrectomy was enough to preventvisual axis reproliferation. Combining anterior vitrec-tomy with IOL capture is also considered superfluousby Mullner-Eidenbock et al.10

An alternative to PCCC is the vertical and oval ante-rior and posterior capsulorhexis created with micro-scissors.23 A retrospective analysis of the surgicalrecords showed that without anterior vitrectomy, thevisual axis remained clear in 100% of cases. Themean follow-up was 9 years (range 5 to 12 years).The age of these children was clearly higher than themean age in our series.

After combined ACCC, PCCC, and anterior vitrec-tomy (limbal or pars plicata approach), Kirwan andO’Keeffe24 found no cases of cystoid macular edema



(CME) in aphakic or pseudophakic eyes 4 to 7 weekspostoperatively. Postoperative fundus evaluation ofthe older children in our series did not show clinicalevidence of CME.

Visual outcomes are influenced by the age of the pa-tient.13–16,25 The earlier the surgery is performed, thebetter the final visual acuity. Visual acuity in unilateralcataract groups is always worse than in the bilateralcataract groups.13–16,25 Unilateral aphakic eyes haveworse visual acuity outcomes (33.3% 20/200 or better)than unilateral pseudophakic eyes (45.5% 20/60 orbetter). Bilateral aphakic eyes also have worse visualacuity outcomes (35.3% 20/30 or better) than bilateralphakic eyes (63.7% 20/20 or better).13–16,25

In this series, visual acuity was measurable in 20eyes in 14 bilateral cases and was 20/25 or better in80% and 20/40 in 100% of cases. One child in the uni-lateral group who had PFV had an acuity of 20/63; theother 3 had an acuity of 20/200.

Secondary glaucoma is a serious sight-threateningcomplication warranting life-long follow-up.9 For ac-curate measurement, the IOPmust be taken before pu-pil dilation because a dramatic decrease in IOP hasbeen reported after instillation of mydriatics.26 Ina study byWatts et al.,27 16 of 80 eyes developed glau-coma a mean of 8.9 months postoperatively. When thesurgery took place between 14 days and 43 days of life,glaucoma was more prevalent than when surgery wasperformed in the first 2 weeks of life. Chen et al.28 re-viewed a series of patients with aphakic glaucomaand found 80.6% had cataract surgery before the ageof 1 year. In eyes operated on before the age of 4.5months, the incidence of glaucoma is particularlyhigh.29 This agrees with the findings of Lundvall andKugelberg,14 who found severe glaucoma in 4 of 12children operated on before they were 6 weeks old.In a series of 157 eyes operated on for congenital cata-ract, Speeg-Schatz et al.25 found only 3 eyes with post-operative glaucoma. In 1 case, the diagnosis was made11 years after surgery. Intraocular lens implantationdoes not seem to protect against glaucoma. In onestudy,29 the incidence of glaucoma was 24.4% in pseu-dophakic eyes and 19.0% in aphakic eyes. Koc et al.30

report bimodal onset of glaucoma, with early-onsetglaucoma occurring at a mean age of 6 months (likelyresulting from angle closure) and delayed-onset glau-coma at a mean age of 12 years (in 86%, resulting froman open filtration angle). Chen et al.28 found an openangle in 93.9% of cases of aphakic glaucoma.

CONCLUSION

Bag-in-the-lens IOL implantation in babies and chil-dren yielded promising results. Although this IOLmay be difficult to implant in very small babies and

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eyes with concomitant congenital malformations, wewere able to implant it in all children older than 6months. A smaller version of the bag-in-the-lens IOLwith an optic diameter of 4.5 or 4.0 mm could improvethe success rate of implantation in the very small eyesof babies.

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First author:Marie-Jose Tassignon, MD, PhD, FEBO

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Bag-in-the-lens intraocular lens implantation in the pediatric eye