Correction of Undesirable Pseudophakic Refractive Error ... · approach is the implantation of a...

$: Correction of Undesirable Pseudophakic Refractive Error ... · approach is the implantation of a new supplementary sulcus IOL using the piggyback technique.10,11 Secondary piggyback$
614 Copyright © SLACK Incorporated

nexpected postoperative refractive surprises are a common cause of patient dissatisfaction and re-main an important and challenging issue for oph-

thalmic surgeons.1 Surgical options for subsequent correction of residual refractive error after cataract surgery include cor-neal and limbal relaxing incisions,2 intraocular lens (IOL) ex-change,3 and keratorefractive laser surgery.4-7 More recently, a light adjustable intraocular lens (LAL; Calhoun Vision Inc, Pasadena, California) has been introduced.8,9 An alternative approach is the implantation of a new supplementary sulcus IOL using the piggyback technique.10,11

Secondary piggyback lenses offer various advantages over IOL exchange including decreased intraoperative maneuvers that could lead to capsule rupture and a simpler method of IOL power calculation.1 Piggyback lenses also potentially al-low for a smaller incision unless the primary foldable IOL is cut in half prior to explantation. However, IOLs designed solely for the capsular bag are not appropriate for placement in the ciliary sulcus. Complications related to placement of a conventional IOL in the sulcus include pigment dispersion, iris transillumination defects, dysphotopsia, elevated intra-ocular pressure (IOP), intraocular hemorrhage, and cystoid macular edema.12

The recently introduced Sulcofl ex IOL (Rayner Intraocu-lar Lenses Ltd, East Essex, United Kingdom) is designed for implantation as a piggyback IOL in the ciliary sulcus of the pseudophakic eye and has design attributes calculated to overcome the disadvantages of conventional IOLs.10,11 The technology of a compound IOL that could be placed in the sulcus over a previously implanted IOL has been available, at least conceptually, for more than 10 years.13 The objective of this study was to evaluate the visual outcomes, effi cacy, predictability, and short-term safety of this novel piggyback

UABSTRACT

PURPOSE: To evaluate the visual outcomes, effi cacy, predictability, and short-term safety of implanting the Sulcofl ex (Rayner Intraocular Lenses Ltd) intraocular lens (IOL) to correct residual pseudophakic errors.

METHODS: Retrospective study of patients undergoing implantation of the Sulcofl ex IOL. Uncorrected (UDVA) and corrected (CDVA) distance visual acuity and refrac-tive outcomes were evaluated. Postoperative follow-up was at 1 week and 1, 3, 6, and 12 months.

RESULTS: Fifteen eyes (13 patients) were evalu-ated. Mean follow-up was 20 months (range: 14 to 30 months). The Sulcofl ex aspheric (653L) and toric (653T) IOLs were implanted in 3 and 12 eyes, respec-tively. Preoperatively, mean logMAR (Snellen) UDVA and CDVA were 0.44 (20/55) and 0.05 (20/22), respectively. At 3 months, all eyes achieved logMAR UDVA of 0.20 (20/32) or better, with 10 (67%) eyes achieving UDVA of 0 (20/20) or better. Preoperative mean spherical and astigmatic errors were 1.0760.83 diopters (D) and 21.4560.98 D, respectively. Preoperative mean spher-ical equivalent refraction was 20.5461.11 (D). Post-operative mean sphere and astigmatism at 3 months were 20.2560.38 D and 20.5060.57 D, respectively. Postoperative mean spherical equivalent refraction at 3 months was 20.1560.28 D. All patients were within 1.00 D of attempted correction, with 93% within 0.50 D. Linear regression analysis showed good correlation (R2=0.72) between attempted versus achieved spheri-cal equivalent refractions. No signifi cant intra- or post-operative complications occurred.

CONCLUSIONS: Implantation of the Sulcofl ex IOL was found to be an effective and predictable option for enhancing postoperative refractive results and reduc-ing spectacle dependence for distance after surgery. The IOL was well tolerated in all eyes. [J Refract Surg. 2012;28(9):614-619.] doi:10.3928/1081597X-20120809-01

From Hull and East Yorkshire Eye Hospital, Hull, United Kingdom.

The authors have no financial or proprietary interest in the materials pre-sented herein.

Correspondence: Kevin Falzon, MD, MRCOphth, Hull and East Yorkshire Eye Hospital, Fountain St, Hull, HU3 2JZ, United Kingdom. Tel: 447506614819; Fax: 441482875875; E-mail: [email protected]

Received: November 6, 2011; Accepted: July 24, 2012

Correction of Undesirable Pseudophakic Refractive Error With the Sulcofl ex Intraocular Lens

Kevin Falzon, MD, MRCOphth; Owen G. Stewart, FRCOphth

Reprinted from The JOURNAL OF REFRACTIVE SURGERY, September 2012. Copyright© 2012, SLACK Incorporated. All rights reserved.

615Journal of Refractive Surgery • Vol. 28, No. 9, 2012

Correction of Pseudophakic Refractive Error With the Sulcoflex IOL/Falzon & Stewart

IOL to correct residual pseudophakic spherical and cylindrical errors.

PATIENTS AND METHODS

A chart review was conducted for all patients (identifi ed from an electronic database) who received a Sulcofl ex IOL for correction of residual refractive er-ror between January 2010 and April 2011. One patient with previous penetrating keratoplasty was excluded. The time interval between primary surgery and sec-ondary Sulcofl ex surgery was a minimum of 3 months. Preoperative assessment prior to Sulcofl ex implanta-tion surgery included measurement of Snellen uncor-rected (UDVA) and corrected (CDVA) distance visual acuity, refraction, and keratometry. All patients had at least two stable subjective refractions prior to second-ary surgery. Axial length and anterior chamber depth were measured with the IOLMaster (Carl Zeiss Med-itec AG, Jena, Germany). Slit-lamp microscopy, appla-nation tonometry, and fundus examination were per-formed for all patients. Written informed consent was obtained from all patients before surgery. This research followed the tenents of the Declaration of Helsinki.

Patients received either a Sulcofl ex aspheric (653L) or toric (653T) IOL based on two stable preoperative re-fractions, keratometry, and axial length measurements. The Sulcofl ex multifocal IOL was not assessed in our study. Calculation of the required spherical and cylin-drical powers of the IOL to achieve distance emmetro-pia and maximum astigmatic correction was performed using a web-based customized formula (Raytrace toric caluclator, http://www.rayner.com/raytrace/) devel-oped by the manufacturer. Calculations can also take account of surgically induced astigmatism (SIA) and axis for any new incision to achieve a target refraction of distance emmetropia. The new incision was specifi ed on the steep meridian in the calculations for all patients to minimize any signifi cant SIA affecting the postopera-tive result.

The same surgeon (O.G.S.) performed all secondary IOL implantations. The cornea was marked preopera-tively at the slit lamp using a needle to mark the hori-zontal meridian with the patient sitting upright and looking straight ahead. The steep meridian was marked intraoperatively using the Mendez ring (Malosa Medi-cal, Elland, England) and ink. An on-axis, self-sealing, clear corneal incision (2.75 mm) using a standardized technique was performed. The anterior chamber and retroiridial space were fi lled with an ophthalmic vis-cosurgical device (OVD). The secondary IOL was im-planted in the ciliary sulcus using the supplied one-piece, single-use injector. The IOL was rotated to the desired axis by aligning the cylinder axis with the

steep corneal meridian. The IOL has linear marks on its anterior surface to allow correct surgical alignment. The OVD was meticulously washed out and cefurox-ime (1.0 mg in 0.1 mL) was injected intracamerally. Correct alignment of the IOL was verifi ed at the end of surgery and at the slit lamp. After surgery, all patients received topical tobramycin-dexamethasone eye drops for 4 weeks.

All patients were examined 2 hours, 1 week, and 1, 3, 6, and 12 months postoperatively and as required. At each follow-up examination, Snellen UDVA was deter-mined. Snellen CDVA was obtained following subjec-tive refraction performed at 3 months postoperatively. Slit-lamp examination was performed to subjectively assess anterior chamber fl are, iris transillumination, and pigment dispersion. Intraocular pressure measure-ment was followed by dilated funduscopy. Dilation al-lowed subjective verifi cation of correct axis alignment but alignment was not formally measured with digital retroillumination imaging or anterior segment ultra-sound biomicroscopy.

For statistical analysis, Snellen acuity was converted to logarithm of the minimum angle of resolution (log-MAR) acuity. Descriptive statistics were calculated for various clinical characteristics. All data were analyzed using a Microsoft Excel (Microsoft Corp, Redmond, Washington) spreadsheet to produce standardized graphs.14 Linear regression analysis was performed to assess predictability. Vector analysis using pre- and postoperative refractive measurements was performed with Datagraph-med (version 4.10; Datagraph-med, Wendelstein, Germany).

RESULTS

The study evaluated 15 eyes from 13 patients. Mean patient age was 63 years (range: 52 to 81 years). Mean follow-up was 12 months (range: 5 to 21 months). The Sulcofl ex aspheric (653L) and toric (653T) IOLs were implanted in 3 and 12 eyes, respectively.

Preoperatively, mean logMAR (Snellen) UDVA was 0.4460.21 (20/55) (range: 0.20 to 0.78) and mean log-MAR CDVA was 0.0560.07 (20/22) (range: 20.20 to 0.10). All patients had improved UDVA postoperatively. At last follow-up, all eyes achieved logMAR UDVA of 0.20 (20/32) or better, with 10 (67%) eyes achieving logMAR UDVA of 0 (20/20) or better (Fig 1). No patient lost any lines of UDVA or CDVA (Fig 2).

Postoperatively, mean sphere at 3 months was 20.2560.38 diopters (D) (range: 0.25 to 20.50 D). Postoperative mean spherical equivalent refraction at 3 months was 20.1560.28 D (range: 0.38 to 20.75 D). All patients were within 1.00 D of attempted correc-tion, with 93% within 0.50 D (Fig 3). Linear regression



Figure 1. Cumulative plot of pre- and postoperative uncorrected dis-

tance visual acuity (UDVA). Figure 2. Change in corrected distance

visual acuity (CDVA). Figure 3. Equivalency plot of attempted versus

achieved spherical equivalent refraction. Figure 4. Spherical equivalent

refractive accuracy. Figure 5. Change in magnitude of astigmatism.

1 2

43

5



analysis showed good correlation (R2=0.72) between attempted versus achieved spherical equivalent refrac-tions (Fig 4).

Pre- and postoperative mean refractive astigmatism were 21.4560.98 D (range: 20.25 to 23.00 D) and 20.5060.57 (range: 0 to 21.25 D), respectively. Thir-teen (87%) eyes were within 1.00 D postoperatively, with 10 (67%) eyes within 0.50 D (Fig 5). Double-angle plots of the pre- and postoperative refractive astigma-tism are shown in Figure 6.

No intraoperative complications occurred. None of the Sulcofl ex IOLs needed to be repositioned at the end of surgery. One (6.7%) eye had an IOP increase to 23 mmHg 1 month postoperatively. The IOP remained stable without treatment throughout follow-up (4 months). Three (20%) eyes had increased anterior chamber fl are 1 month postoperatively treated with a further 4 weeks of topical prednisolone acetate (1%). Following dila-tion and retroillumination, all IOLs were well-centered and no cases of IOL rotation or tilt were observed. No interlenticular opacifi cation or other postoperative complications related to piggyback IOLs (eg, pigment dispersion syndrome, pupillary block glaucoma) were observed. No eyes required further surgery or removal of the secondary IOL. At last follow-up, 12 (92%) patients were spectacle-independent for distance. One patient with logMAR UDVA of 0.2 (20/32) was prescribed distance spectacles achieving logMAR CDVA of 20.1 (20/16). No other visual disturbances were reported.

DISCUSSION

In this study, the Sulcofl ex IOL offered an effective method to correct unexpected postoperative visually

signifi cant refractive error and astigmatism. All pa-tients achieved logMAR UDVA of 0.20 (Snellen 20/32) or better associated with a reduction in refractive astig-matism.

Refractive surprises are usually due to placement of an incorrect power IOL as a result of a preopera-tive error in axial length measurement or keratometry. However, postoperative decentration or axial shift of the IOL can lead to a discrepancy between expected and fi nal visual outcome, despite remarkable develop-ments in biometry, IOL manufacture, and operative techniques.15,16 During the healing process, anterior movement of the IOL results from postoperative cap-sular bag fi brosis and contraction. Studies have shown mean myopic shifts in spherical equivalent refraction of 0.70 D from 1 day postoperatively out to 2 months.17 The time interval in our study between primary sur-gery and secondary Sulcofl ex surgery was a minimum of 3 months. Furthermore, all patients had at least two stable subjective refractions prior to secondary surgery to minimize errors in refraction due to axial movement of the primary IOL.

Pentacam (Oculus Optikgeräte GmbH, Wetzlar, Ger-many) studies of the implanted Sulcofl ex IOL have shown a signifi cant distance between the IOL from the iris anteriorly and the primary IOL posteriorly, signifi cantly reducing the risk of iris chafi ng.10 Very high-frequency digital ultrasound (Artemis; ArcScan Inc, Morrison, Colorado) assessment of Sulcofl ex IOL insertion in the ciliary sulcus in pseudophakic human cadaver eyes showed overall appropriate centration and minimal or no tilt.17 Follow-up examinations to date showed no evidence of iris chafi ng, pigment dis-

Figure 6. Double-angle plots of the A) pre- and B) postoperative refractive astigmatism.

A B



persion, or interlenticular opacifi cation in our series indicating minimal interaction of the Sulcofl ex IOL with the primary IOL and uveal tissues.

Alternative surgical methods for subsequent cor-rection of unexpected residual refractive error after cataract surgery include corneal and limbal relaxing incisions, keratorefractive laser surgery, IOL exchange, or more recently, implantation of a LAL.2-9 Relaxing incisions can correct low and moderate astigmatic errors, but are less precise, and can be complicated by placement on the incorrect axis, perforation, pain, and infection.2 One patient in our series who had previ-ous unsuccessful limbal relaxing incisions achieved an improvement in logMAR UDVA from 0.3 (20/40) to 0 (20/20) following Sulcofl ex IOL implantation. Laser refractive surgery is also effective and safe for the correction of residual refractive error. However, it could create potential complications that might be more common in older patients related to dry eye and wound healing.18

Although the overall incidence of IOL exchange for correcting unexpected refractive errors after cataract surgery has decreased over the past decade, incorrect IOL power remains a common indication for foldable IOL exchange.19 If the error is discovered early in the postoperative course, the visual outcome can be very good after IOL exchange and remains an effective op-tion for the timely treatment of incorrect IOL power after cataract surgery. Intraocular lens exchange is a challenging process, especially if delayed, as it in-volves removing the existing IOL before implantation of a new one. The additional manipulation required due to strong IOL adhesion to the capsular bag increases the risk for retinal tears, cystoid macular edema, cyclo-dialysis, and posterior or anterior capsule rupture.1 Nd:YAG laser capsulotomy performed after primary surgery also signifi cantly increases the rate of anterior vitrectomy, further complicating the secondary IOL exchange procedure.3 The sulcus implantation of the secondary IOL was safe and relatively atraumatic. No serious intra- or postoperative complications were noted in our series and no patient lost any lines of CDVA.

One major advantage of piggybacking with the Sul-cofl ex IOL is predictability. The power calculation for the supplementary IOL depends solely on the patient’s current postoperative, not preoperative, measurements. Each Sulcofl ex IOL was chosen using the web-based customized calculator. Insertion of keratometric data and desired postoperative spherical equivalent refrac-tion produced a selection of appropriate lenses. Surgi-cally induced astigmatism and incision axis can also be factored into the lens choice. Our results showed good predictability of secondary piggyback Sulcofl ex

IOL implantation. In contrast, one of the limitations of IOL exchange is the diffi culty predicting the power of the replacement IOL. Few studies have evaluated power calculation for in-the-bag IOL exchange20 and it requires an accurate knowledge of the IOL power of the previous surgery, which may not always be avail-able.1 Moreover, the accuracy of the power calculation can be affected if the original IOL had been unknow-ingly mislabeled or axial displacement of the IOL oc-curred due to capsular contraction. A further advan-tage is reversibility. Unlike refractive laser correction, the supplementary Sulcofl ex IOL may be explanted from the sulcus if necessary. No eyes required removal of the secondary IOL in our series.

Recent studies have shown promising results for cor-rection of residual hyperopic or cylindrical refractive errors following cataract surgery using LAL technology (Calhoun Vision Inc). The refractive power of the IOL can be adjusted and “locked-in” postoperatively by the application of near-ultraviolet light.8,9,21 Also, because most cataract surgeons may not have equal access to a refractive laser, the Sulcofl ex IOL may provide an ex-cellent, yet cheaper, alternative to laser adjustment of IOL power in the eye.

A large cohort of postoperative refractive laser sur-gery patients will require cataract surgery in the near future, all of whom will have high expectations. As corneal power is often overestimated, these patients are frequently left hyperopic after cataract surgery. The Sulcofl ex IOL may be a feasible method for correcting any residual hyperopic error following cataract surgery in this patient cohort. The multifocal Sulcofl ex IOL also enables correction of pseudophakic presbyopia, thereby signifi cantly reducing the need for additional near correction. Successful spectacle independence following secondary Sulcofl ex insertion in one patient after bilateral LASIK and refractive lens exchange with an accommodating IOL has recently been reported.11 In the same study, the authors achieved logMAR UDVA of 0.1 (20/25) or better and uncorrected near visual acuity of N6 (Jaeger 4) or better using the multifocal Sulcofl ex IOL.11 The multifocal Sulcofl ex IOL was not assessed in our series.

Our study has several limitations including its retrospective nature and small patient cohort. First, piggyback IOL implantation with placement of two foldable IOLs in the capsular bag can be followed by a signifi cant hyperopic shift occurring between 1 and 2 years after implantation.22 This may be caused in part by interlenticular opacifi cation, resulting in displace-ment of the IOLs as demonstrated using Scheimpfl ug photography.23 This was not observed in our series. Although this could be due to shorter follow-up and



small study sample size, it is most likely due to im-plantation of the secondary IOL in the ciliary sulcus with all primary IOLs in the capsular bag in our series. Second, postoperative evaluation was not uniform over time. Third, correct axis alignment, decentration, and tilt, which are major concerns, were only performed subjectively and were not assessed further during the study period with digital retroillumination imaging or ultrasound biomicroscopy. Furthermore, specifi c tests other than UDVA (eg, contrast sensitivity, wavefront analysis) or patient satisfaction questionnaires may be better indicators of subjective satisfaction. However, 92% of patients in this study were satisfi ed with the outcomes of the IOL exchange procedure, with the surgery improving or resolving their visual symptoms. Despite these limitations, our data suggest the viability of the Sulcofl ex IOL as a surgical option for the treat-ment of such eyes.

Implantation of the Sulcofl ex IOL was a predictable and effective method for enhancing the refractive out-come and reducing spectacle dependence for distance in pseudophakic eyes. Appropriate patient selection, accurate preoperative measurements, good intraopera-tive technique, and careful postoperative management can result in excellent outcomes with minimal risk of complications. As with all refractive procedures, real-istic expectations should be established before surgical intervention.

AUTHOR CONTRIBUTIONS

Study concept and design (K.F., O.G.S.); data collection (K.F.);

analysis and interpretation of data (K.F.); drafting of the manuscript

(K.F.); critical revision of the manuscript (K.F., O.G.S.); statistical

expertise (K.F.); supervision (O.G.S.)

REFERENCES 1. Jin GJ, Crandall AS, Jones JJ. Intraocular lens exchange due to

incorrect lens power. Ophthalmology. 2007;114(3):417-424.

2. Kaufmann C, Peter J, Ooi K, et al. Limbal relaxing incisions ver-sus on-axis incisions to reduce corneal astigmatism at the time of cataract surgery. J Cataract Refract Surg. 2005;31(12):2261-2265.

3. Leysen I, Bartholomeeusen E, Coeckelbergh T, Tassignon MJ. Surgical outcomes of intraocular lens exchange: fi ve-year study. J Cataract Refract Surg. 2009;35(6):1013-1018.

4. Ayala MJ, Perez-Santonja JJ, Artola A, et al. Laser in situ ker-atomileusis to correct residual myopia after cataract surgery. J Refract Surg. 2001;17(1):12-16.

5. Kuo IC, O’Brien TP, Broman AT, Ghajarnia M, Jabbur NS. Ex-cimer laser surgery for correction of ametropia after cataract surgery. J Cataract Refract Surg. 2005;31(11):2104-2110.

6. Kim P, Briganti EM, Sutton GL, et al. Laser in situ keratomileusis for refractive error after cataract surgery. J Cataract Refract Surg. 2005;31(5):979-986.

7. Jin GJ, Merkley KH, Crandall AS, Jones YJ. Laser in situ ker-atomileusis versus lens-based surgery for correcting residual refractive error after cataract surgery. J Cataract Refract Surg. 2008;34(4):562-569.

8. Chayet A, Sandstedt CA, Chang SH, Rhee P, Tsuchiyama B, Schwartz D. Correction of residual hyperopia after cataract sur-gery using the light adjustable intraocular lens technology. Am J Ophthalmol. 2009;147(3):392-397.e1.

9. Lichtinger A, Sandstedt CA, Schwartz DM, Chayet AS. Cor-rection of astigmatism after cataract surgery using the light adjustable lens: a 1-year follow-up pilot study. J Refract Surg. 2011;27(9):639-642.

10. Kahraman G, Amon M. New supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010;36(7):1090-1094.

11. Khan MI, Muhtaseb M. Performance of the Sulcofl ex piggy-back intraocular lens in pseudophakic patients. J Refract Surg. 2011;27(9):693-696.

12. Chang DF, Masket S, Miller KM, et al. Complications of sulcus placement of single-piece acrylic intraocular lenses: recom-mendations for backup IOL implantation following posterior capsule rupture. J Cataract Refract Surg. 2009;35(8):1445-1458.

13. Werblin TP, Shalon T, Roberts JE, inventors; Emmetropia Inc, assignee. Compound intraocular lens. US patent 5,968,094. October 19, 1999.

14. Waring GO III, Reinstein DZ, Dupps WJ Jr, et al. Standardized graphs and terms for refractive surgery results. J Refract Surg. 2011;27(1):7-9.

15. Kim KH, Kim WS. Intraocular lens stability and refractive out-comes after cataract surgery using primary posterior continuous curvilinear capsulorrhexis. Ophthalmology. 2010;117(12):2278-2286.

16. Werblin TP. Capsular apposition after cataract surgery. Ophthalmology. 2004;111(2):409.

17. McIntyre JS, Werner L, Fuller SR, Kavoussi SC, Hill M, Ma-malis N. Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus fi xation in pseudophakic cadaver eyes. J Cataract Refract Surg. 2012;38(1):155-162.

18. Battat L, Macri A, Dursun D, Pfl ugfelder SC. Effects of laser in situ keratomileusis on tear production, clearance, and the ocular surface. Ophthalmology. 2001;108(7):1230-1235.

19. Mamalis N, Brubaker J, Davis D, Espandar L, Werner L. Compli-cations of foldable intraocular lenses requiring explantation or secondary intervention--2007 survey update. J Cataract Refract Surg. 2008;34(9):1584-1591.

20. Kora Y, Shimizu K, Yoshida M, Inatomi M, Ozawa T. Intraocu-lar lens power calculation for lens exchange. J Cataract Refract Surg. 2001;27(4):543-548.

21. Chayet A, Sandstedt C, Chang S, et al. Use of the light-adjust-able lens to correct astigmatism after cataract surgery. Br J Oph-thalmol. 2010;94(6):690-692.

22. Shugar JK, Schwartz T. Interpseudophakos Elschnig pearls associated with late hyperopic shift: a complication of piggy-back posterior chamber intraocular lens implantation. J Cataract Refract Surg. 1999;25(6):863-867.

23. Baumeister M, Kohnen T. Scheimpfl ug measurement of intra-ocular lens position after piggyback implantation of foldable in-traocular lenses in eyes with high hyperopia. J Cataract Refract Surg. 2006;32(12):2098-2104.

10187r

Correction of Undesirable Pseudophakic Refractive Error ... · approach is the implantation of a...

Documents

Transcript of Correction of Undesirable Pseudophakic Refractive Error ... · approach is the implantation of a...