There are various surgical techniques available for implanting intraocular lens (IOL) in an aphakic patient like Transcleral fixation of IOL (TSFIOL), Glued TSFIOL, and Yamane technique. All the above techniques are generally meant to be one-time procedure and an attempt to exchange the scleral fixated IOL in case of myopic shift or refractive surprise can be quite traumatic to the eye. We have devised an artificial IOL platform, which we have called as JBISS (Jagat and Bala Intraocular lens Supporting System) for aphakic patients. Through this technique, not only can we fix the IOL but it also facilitates IOL exchange in case of myopic shift or refractive surprise. We have successfully implanted JBISS assisted IOL in four patients [Table 1] and describe our technique in this paper.
Jagat and Bala Intraocular Lens Supporting System (JBISS)
The device was made up of hydrophilic acrylic material which comes in an universal single size of 13.5 mm, which can be expanded (up to ~15 mm) or compressed (up to ~11.00 mm) depending on the diameter of the sulcus of the patient and is self-adjustable with the increasing diameter of the sulcus when the eye grows with the age. The thickness is 0.3 mm which is uniform throughout the device and weighs 20 mg. Fig. 1 describes the various parts of the device. The device is divided into two parts – body and supporting parts. Body (6) has IOL haptic holder (1) (no function at present, only for future development) and optic holder (5); The supporting part consists of a pair of wing of JBISS (2) with one hole on each wing and each wing has one haptic of the JBISS (3) attached to it. The wing was provided with the space (7) which facilitates the compression and expansion of the device. The interholder groove is the small space between the two optic holders. The central space (4) is where the optic part of the three-piece IOL will be captured. The wing was angulated by 5 degree anteriorly with the central body which make the IOL and JBISS complex away from the Iris tissue. The device was crafted by Appasamy Associates (P) Ltd., Chennai. The device is applied for the Indian patent (Application no. 202041034562).
Informed consent of the patients and institutional ethical clearance were obtained. The surgical technique is divided into two parts [Video 1].
Part 1: Suturing the JBISS to the sclera with 9-0 polypropylene suture (as described by lewis et al.).
Part 2: Injecting the foldable three-piece IOL (eg. Sensar 3-piece AR40e, Johnson and Johnson vision) inside the eye and fixing it to the JBISS implant by optic capture.
The main surgical steps involve the creation of fornix-based localized peritomy at around 2’o clock and 8’o clock followed by partial thickness rectangular scleral flaps [Figs. 2a and 3a]. One end of the 9-0 polypropylene suture (long arm) was passed through the bed of the scleral flap, 1.5 mm away from the limbus at 8’o clock and simultaneously 26G needle is passed through the bed of the scleral flap, 1.5 mm away from the limbus at 2’o clock and inserting the long arm needle into the 26G needle inside the eye [Figs. 2b and 3b]. Paracentesis was done at the limbus at 3’o clock and 9’o clock and anterior chamber maintained either by AC maintainer or viscoelastic material or both. Main clear corneal incision (approx. 4 mm) was made at 11’o clock and polypropylene suture was brought from inside to outside using Mcpherson forceps through the main corneal incision which formed the sutural loop to be cut later [Figs. 2c and 3c]. Both the cut ends of the suture were tied firmly to the two holes provided in JBISS [Fig. 2d and 3d]. The JBISS with the inverted “S” orientation was folded along its vertical axis using Mcpherson forceps and then inserted into the anterior chamber [Fig. 2e and 3e] and simultaneous pulling of polypropylene sutures apart (from the scleral bed) which prevents tangling. Now both the sutures were tied to the sclera at each scleral bed [Figs. 2f and 3f] after making proper centration and alignment of the JBISS implant inside the eye. Three-piece IOL was injected through the injector and dialed the IOL over the JBISS implant to make the haptics of the IOL align between the optic holders (i.e over the interholder groove) [Figs. 2g and 3g]. The Optic part of the IOL was nudged at its edge or slided below the two adjacent “optic holders” using Y- rotator [Figs. 2h and 3h]. Similarly, other side of the optic was also nudged using two Y-rotators (one Y-rotator nudges the optic of the IOL and other Y-rotator gives counter pressure to JBISS) [Figs. 2i and 3i] and hence the IOL was fixed to the JBISS by means of Optic capture. Viscoelastic material was washed out and main port, scleral flap and peritomy were sutured [Figs. 2j and 3j].
The various causes of poor capsular support are trauma, genetic diseases (Marfan syndrome and homocystinuria), and complicated cataract surgery. The surgical options for aphakia are anterior chamber IOL (ACIOL), iris fixated IOL (IFIOL), and Transcleral fixation of IOL (TSFIOL). There are more complications associated with ACIOL and IFIOL like corneal decompensation, glaucoma, and UGH syndrome. The TSFIOL is relatively safer with respect to anterior segment but it also has its own complications like retinal detachment, IOL dislocation, IOL tilt, and decentration. Scleral-Fixated IOL is of two types: 1. Sutured TSFIOL 2. Sutureless TSFIOL (Glued TSFIOL, Yamane, etc). The basic technique of sutured TSFIOL described by Malbran et al. was suturing the haptic of IOL to the sclera using 10-0 polypropylene to the sclera 2 mm away from the limbus. Lewis et al. introduced scleral flap to cover the suture knot, thereby, reducing the suture knot exposure and suture-related endophthalmitis. Malta et al. in his cohort study of 105 eyes who underwent combined penetrating keratoplasty and scleral sutured PCIOL, two eyes (1.9%) experienced IOL dislocation due to suture breakage at five and eight years of follow up. Mimura T, et al. in his longitudinal observational study, at 10-year follow-up, there was no single case of suture breakage with 10-0 polypropylene. Buckley experienced IOL dislocation in 4 out of 26 patients (15%) using the 10-0 polypropylene and he strongly suggested to use 9-0 polypropylene suture especially in pediatric population since 9-0 polypropylene has 60% greater tensile strength, 50% greater diameter and 125% greater cross sectional area. In our technique we used 9-0 polypropylene to suture the JBISS implant to the sclera. Agrawal et al. used closed loop haptic foldable IOL (C-Flex 570C, Rayner intraocular lenses Ltd., UK) made up of hydrophilic acrylic material for TSFIOL which is actually meant for “in the bag implantation” and they concluded that use of hydrophilic acrylic IOL can be safely used as TSFIOL. In our novel JBISS implant, we used hydrophilic acrylic material which is a biocompatible material, safe for intraocular use with long history of use in ophthalmology clinical practice. Optical coherence tomography was done which showed well centered and parallely placed IOL with respect to the cornea and with overlapping optic holder (arrow) of the JBISS [Fig. 4i]. Ultrasound biomicroscopy was done which shows the clear space between the iris (white arrow) and JBISS IOL complex (red arrow) as shown in Fig. 4j. JBISS assisted IOL implantation has the following advantages i.e., Firstly, JBISS comes in single size which can be expandable as well as compressible hence can be used universally in all age groups (minimum axial length of eye should be ≥17 mm and corneal diameter should be ≥10 mm). Secondly, JBISS acts as an exchangeable IOL platform hence when there is a refractive surprise or high myopic shift in case of children, it facilitates IOL exchange and new IOL can be fixed with similar fashion. Thirdly, in case of extreme cases like Buphthalmos with poor capsular support, JBISS diameter can be customized according to the sulcus diameter and conventional three-piece IOL can be implanted. Fourthly, smaller corneal incision (~4.00 mm) is needed. Fifthly, surgical technique is simple (suturing JBISS to the sclera is similar to suturing the PMMA TSFIOL) and fixing IOL to the JBISS by optic capture (this method of optic capture is similar to the optic capture done with anterior capsule of the natural bag in case of posterior capsular tear). Sixthly, No pseudophakodonesis and hence less chance of pupillary capture.
JBISS implant was found to be effective in treating aphakic patients and can be safely used in the conditions with poor capsular support. Although its outcome is promising in adults, its efficacy can be further evaluated for the pediatric age group. Since it is a prototype model, further Research and Development is needed for refinement and advancement in the device.
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Conflicts of interest
There are no conflicts of interest.
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