Conductive keratoplasty to correct residual hyperopia after cataract surgery

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1 J CATARACT REFRACT SURG - VOL 32, SEPTEMBER 2006 Conductive keratoplasty to correct residual hyperopia after cataract surgery Pascual J. Claramonte, MD, PhD, Jorge L. Alió, MD, PhD, Mohamed I. Ramzy, MD PURPOSE: To evaluate the efficacy, predictability, safety, and stability of conductive keratoplasty (CK) for correcting residual hyperopia after cataract surgery with intraocular lens implantation. SETTING: Vissum-Instituto Oftalmologico de Alicante, Alicante, and Vissum-Instituto de Albacete, Albacete, Spain. METHODS: Sixteeneyesof16patientshadCKforthecorrection of residual hyperopia after cataract surgery. The CK was performed with the CK View Point Refractec (RCS-200, Refractec, Inc.). The follow-up was 12 months. RESULTS: One year after CK, 10 eyes (62.5%) achieved an uncorrected visual acuity (UCVA) of 0.50 or better. The mean UCVA was 0.50 G 0.21 (SD), and the mean best spectacle-corrected visual acuity (BSCVA) was 0.68 G One eye lost 1 line of BSCVA, and none lost 2 or more lines. The mean spherical equivalent refraction was C0.39 G 0.84 D 1 year after CK. No vision-threatening complications occurred. CONCLUSIONS: One-year data show that CK for the correction of low to moderate hyperopia after cataract surgery was safe, stable, relatively predictable, and efficient. No complications occurred when CK was performed after phacoemulsification. J Cataract Refract Surg 2006; 32: Q 2006 ASCRS and ESCRS Phacoemulsification and extracapsular cataract extraction are the most commonly used techniques for cataract surgery 1 and are constantly evolving in an attempt to decrease residual ametropia and postoperative astigmatism. Residual myopia, hyperopia, and astigmatism account for most of the decreased uncorrected visual acuity (UCVA) after Accepted for publication April 11, From the Instituto Oftalmológico de Alicante & Albacete Vissum, Refractive Surgery and Cornea Department (Claramonte, Alió), Miguel Hernández University, Medical School, Alicante, Spain, and the Research Institute of Ophthalmology (Ramzy), Cairo, Egypt. Supported in part by the Spanish Ministry of Health, Instituto de Salud Carlos III, Red Temática de Investigación Cooperativa en Oftalmología (ref C 03/13) Subproyecto Cirugía Refractiva y Calidad Visual and in part by a grant from the Spanish Generalitat Valenciana, ref: Grupos 05/036 Grants and Support for scientific research and technological development in the Comunidad Valenciana for the year No author has a financial or proprietary interest in any material or method mentioned. Corresponding author: Jorge L. Alió, MD, PhD, Vissum-Instituto Oftalmológico de Alicante, Avenida Denia s/n, Edificio Vissum, Alicante, Spain. jlalio@vissum.com. cataract surgery, even though intraocular lens (IOL) power is calculated for emmetropia. 2 The residual refractive error after cataract surgery may be the result of biometric errors, 3,4 inadequate calculation and selection of IOL power, 2 and other reasons. 5 In some cases, the residual refractive defect is intolerable because of anisometropia or it is undesirable because the patient rejects wearing corrective lenses. Contact lens fitting may be necessary in patients with anisometropia in whom spectacles would induce significant and intolerable aniseikonia. Intraocular lens exchange as a secondary procedure is a consideration in cases refractory to these measures. 6 Conductive keratoplasty (CK) is a laserless, electrical current-based (radio frequency 350 khz) technique that steepens corneal contours to reduce hyperopia. The treatment is administered by the stainless steel Keratoplast tip (Refractec, Inc.). The 450 mm long, 90 mm wide tip is inserted in the midperipheral cornea at 8 to 32 treatment spots and releases radio-frequency energy deep in the stroma. Tissue resistance to current flow generates localized heat (65 Cto75 C) that denatures and shrinks the peripheral corneal collagen in a controlled fashion (data on file, Refractec, Inc.). 7 Each cylindrical spot is approximately 150 to 200 mm wide and 500 mm deep (approximately 80% Q 2006 ASCRS and ESCRS Published by Elsevier Inc /06/$-see front matter doi: /j.jcrs

2 of the corneal depth). 7 A circle of treatment spots causes a band of tightening that flattens the peripheral cornea and steepens the central cornea. 8 Treatment spots may be titrated according to the degree of hyperopia. 7 9 Emerging techniques such as CK may eventually become more convenient for residual hyperopia correction after cataract surgery and myopic or hyperopic laser in situ keratomileusis (LASIK) than repeat LASIK. 10 However, CK outcomes for residual hyperopia after cataract surgery have not been systematically studied. 8 This study evaluated the efficacy, safety, stability, and predictability of CK correction of residual hyperopia and hyperopic astigmatism after cataract surgery. PATIENTS AND METHODS This prospective observational noncomparative study comprised 16 eyes of 16 consecutive patients who had CK to correct symptomatic residual hyperopia or hyperopic astigmatism after cataract surgery. Informed consent was obtained from all patients after they received a detailed description of CK and a thorough review of its known risks. The tenets of the Helsinki declaration concerning clinical research investigations 11 were followed in this study. Inclusion criteria were age older than 45 years, spherical equivalent (SE) between C0.50 diopter (D) and C4.50 D, stable refraction (change less than 0.50 D between 2 consecutive examinations), contact lens intolerance, inability to wear glasses because of anisometropia, undesirable residual refractive defect, normal anterior segment, and no general health problems (autoimmune disease, rheumatic fever or other collagen vascular disease, compromised immune system, insulin-dependent diabetes, clinically significant allergies). Exclusion criteria were ocular surgery other than phacoemulsification, corneal abnormality, history of ocular herpes infection, refractive surgery, severe dry-eye syndrome, glaucoma, ocular trauma, and retinal disease. Cataract Surgical Technique Phacoemulsification using a microincision cataract surgery (MICS) technique with posterior chamber IOL implantation was performed in all eyes. Phacoemulsification was performed through 2, 1.5 mm corneal incisions anterior to the corneoscleral limbus vascular arcades. The steepest meridian incision was enlarged to 2.8 mm to implant the IOL. 12 An AcrySof MA60MA IOL (Alcon Laboratories) was implanted in 4 eyes, an AcrySof MA50BM IOL (Alcon Laboratories) in 2 eyes, an ACR6D SE IOL (Corneal) in 3 eyes, an Acri.Sil IOL (Acri.Tec) in 2 eyes, an SA40N Array multifocal IOL (Allergan Medical Optics) in 4 eyes, and an AT-45 IOL (Eyeonics) in 1 eye. Conductive Keratoplasty Surgical Technique One surgeon (J.L.A.) performed all CK procedures. An independent observer (P.J.C.) followed the cases using an agreed protocol with case report forms at all visits. Topical anesthesia was induced with 1 drop of oxybuprocaine hydrochloride 0.4% and tetracaine hydrochloride 0.1% (Colircusí Anestésico Doble), administered 3 times at 5-minute intervals. Pilocarpine was not administered. Conductive keratoplasty was performed with the CK View Point Refractec (RCS-200, Refractec, Inc.). The eyelids were retracted with a Barraquer speculum, which provided maximum exposure and the electrical return path; the fellow eye was taped closed. Illumination was provided by the operating microscope. While the patient fixated on the microscope light, the cornea was marked with a gentian violet dampened, 8 intersection CK marker that marks the 7.0 mm optical zone and makes radial marks that extend from the 6.0 to 8.0 mm optical zones. The surface of the cornea was dried with a fiber-free sponge to avoid dissipation of applied energy through a damp surface. The surgeon placed the Keratoplast tip on the cornea at the treatment markings, maintaining it perpendicular to the corneal surface. The cuff around the probe, which settles perpendicular to the cornea, helped achieve placement. Light pressure was applied until the tip penetrated the stroma to its insulator stop. Energy was applied by depressing the foot pedal. All eyes were treated at the default setting of 350 khz at 60% power for 0.6 seconds. These parameters are set on the console so that each foot-pedal excursion delivers the same level and duration of energy to the keratoplasty tip. All eyes were treated with the sequence, placement, and number of spots indicated by the current nomogram. The probe tip was cleaned of tissue debris with a fiber-free sponge after each treatment spot. All eyes received a single CK treatment, and CK retreatments were not performed. Postoperative Care Eyes were not occluded or patched after the procedure. Patients were examined the following day to rule out immediate postoperative complications. During the first 15 days, the patients received norfloxacin 0.3% (Chibroxin), 1 drop 4 times a day. Unpreserved artificial tear solution (Vislube) was the only other ocular medication used. All eyes were followed for 1 year. Patient Examinations Preoperative and postoperative examinations included visual acuity tested with the decimal chart system at 5 m, manifest refraction, computerized corneal topography (Orbscan, Orbtek), slitlamp biomicroscopy (Shin-Nippon), Goldmann applanation tonometry, indirect ophthalmoscopy, and corneal thickness measurement with an ultrasound pachymeter (DGH-500, DGH Technology, Inc.). Post-CK examinations were conducted at 1 day and 1, 3, 6, and 12 months. The UCVA, best spectacle-corrected visual acuity (BSCVA), and manifest refraction were measured at all examinations. After the first postoperative month, intraocular pressure, keratometry, and topographic changes were recorded after the anterior segment examination. Statistical Analysis Data were analyzed with SPSS/Pc 10.1 software. Descriptive analysis of all parameters was performed by the 1-way analysis of variance (ANOVA). The normality of the data was checked by the Kolmogorov-Smirnov test. The efficacy index, which is the ratio between the mean postoperative UCVA at the end of the follow-up period and the mean preoperative BSCVA, was calculated as follows: mean postoperative UCVA/mean preoperative BSCVA. Efficacy was evaluated by calculating the percentage and/or the number of eyes having a postoperative UCVA from 0.5 to 1.0 at 1446 J CATARACT REFRACT SURG - VOL 32, SEPTEMBER 2006

3 the end of the follow-up period. The predictability was evaluated by calculating the number of eyes having a postoperative SE within G0.50 to G1.00 D of the desired preoperative correction. The safety index, which is the ratio between the mean postoperative BSCVA and the mean preoperative BSCVA, was calculated as follows: mean postoperative BSCVA/mean preoperative BSCVA. RESULTS Of the 16 patients, 6 were men (37.5%) and 10 were women (62.5%). The mean patient age was 60.5 years G 7.89 (SD) (range 50 to 81 years). The mean elapsed time between cataract surgery and CK was 3.57 G 1.38 months (range 2 to 7 months). After cataract surgery and before CK, the mean residual SE refraction was C1.73 G 0.64 D (range C0.75 to C3.00 D). The mean UCVA after cataract surgery was 0.32 G 0.16 (range 0.05 to 0.55), and the mean BSCVA was 0.67 G 0.26 (range 0.2 to 1.0). Four eyes (25.0%) had a UCVA of 0.5 (20/40) or better, and no eye achieved a UCVA of 0.8 (20/25) or better. The mean central corneal keratometric power was G 2.17 D (range to D). Slitlamp Findings One hour after CK, slitlamp examination revealed dense corneal epithelial opacities and epithelial staining with a band of striae connecting the treatment spots at each treatment site as small surface leukomas. There were depressions in the anterior surfaces at treatment spot sites, accompanied by noticeable central curvature steepening. Opacities in all treatment spots decreased over time. Efficacy The mean UCVA after CK was 0.39 G 0.18 (range 0.1 to 0.7) at 1 month, 0.44 G 0.19 (range 0.1 to 0.7) at 3 months, 0.5 G 0.23 (range 0.05 to 0.95 D) at 6 months, and 0.5 G 0.21 (range 0.05 to 0.95) at 12 months (Figure 1). Differences in UCVA before and after CK were statistically significant at all follow-up intervals (P!.01, 1-way ANOVA). There were no significant differences in UCVA after CK at any follow-up examination (PO.05, 1-way ANOVA). There were no significant differences between the patients at 1 month and 3 months or between 6 months and 12 months (PO.05, 1-way ANOVA). There were statistically significant differences between the patients at 1 month and 6 months (P!.01) and the patients at 1 month and 12 months (P!.01). Also, there were statistically significant differences between the patients at 3 months and 6 months (P!.01) and the patients at 3 months and 12 months (P!.01). In 8 eyes (50.00%) at 1 month, 9 eyes (56.25%) at 3 months, 10 eyes (62.50%) at 6 months, and 10 eyes (62.50%) at 12 months, UCVA was 0.5 (20/40) or better. One eye (6.25%) achieved a UCVA of 0.8 (20/25) or better at 12 months. The efficacy index was 0.66 after 3 months and 0.75 after 12 months. Safety No intraoperative complications or treatment-related adverse events occurred. The mean BSCVA after CK was 0.59 G 0.25 (range 0.2 to 1.0) at 1 month, 0.62 G 0.24 (range 0.2 to 1.0) at 3 months, 0.67 G 0.26 (range 0.2 to 1.0) at 6 months, and 0.67 G 0.24 (range 0.2 to 1.0) at 1 year (Figure 2). The BSCVA 6 months and 12 months after CK was similar to that before CK (PO.05, 1-way AN- OVA). The safety index was 0.93 at 3 months and 1.0 after 6 months and 12 months. Twelve months after CK, 2 eyes (12.50%) gained 2 lines of BCVA and 1 eye (6.25%) lost 2 lines. Stability The mean manifest postoperative SE refraction after CK was 0.03 G 0.99 D (range 2.38 to C1.38 D) at 1 month, C0.05 G 0.95 D (range 2.50 to C1.25 D) at 3 months, C0.4 G 0.86 D (range 1.25 to C2.12 D) at 6 months, and C0.39 G 084 D (range 1.25 to Figure 1. Uncorrected visual acuity (UCVA) (mean G SD) over time in 16 eyes having CK for residual hyperopia after cataract surgery. J CATARACT REFRACT SURG - VOL 32, SEPTEMBER

4 Figure 2. Best spectacle-corrected visual acuity (BSCVA) (mean G SD) over time in 16 eyes having CK for residual hyperopia after cataract surgery. C2.00 D) at 12 months (Figure 3). The differences between preoperative and postoperative values were statistically significant at all follow-up intervals (P!.01, 1-way ANOVA). There were no significant differences between the patients at 1 month and 3 months or at 6 months and 12 months (PO.05, 1-way ANOVA). There were statistically significant differences between the patients at 1 month and the patients at 6 months (P Z.001) and 12 months (P Z.001) and between the patients at 3 months and the patients at 6 months (P Z.001) and 12 months (P Z.001, 1-way ANOVA). Predictability After cataract surgery (previous CK), 5 eyes (31.25%), had an SE refraction within G1.00 D and no eye within G0.50 D of emmetropia. After CK, the SE refractive was within G1.00 D of emmetropia in 3 eyes (81.25%) at 1 month, 14 eyes (87.50%) at 3 months, 12 eyes (75.00%) at 6 months, and 13 eyes (81.25%) at 12 months. It was within G0.50 D in 7 eyes (43.75%) at 1 month and 3 months and in 9 eyes (56.25%) at 6 months and 1 year. The mean postoperative central corneal keratometry was G 2.92 D at 1 month, G 2.9 D at 3 months, G 2.86 D at 6 months, and G 2.81 at 12 months. The differences between values before and after CK were significant at all follow-up intervals (P!.01, 1-way ANOVA). There were no significant differences in postoperative central keratometric values after CK (PO.05, 1-way ANOVA). Complications During the first days after surgery, patients reported discomfort and photophobia. A demonstrable increase in the central keratometry readings and corneal topography occurred immediately after treatment. Figures 4 and 5 show the differences between the preoperative and postoperative topographies. There were no treatment-related adverse events or IOL-related problems in any eye (Figure 6). DISCUSSION Phacoemulsification with IOL implantation is 1 of the most common ophthalmic surgeries in the general ophthalmic practice. 10,13 Severe complications are rare, and postoperative problems are mainly related to surgically induced astigmatism and residual refractive errors. 2,10,14 16 Figure 3. Spherical equivalent refraction (mean G SD) after CK to correct residual hyperopia after cataract surgery in 16 eyes J CATARACT REFRACT SURG - VOL 32, SEPTEMBER 2006

5 Figure 4. Preoperative CK topography. Hyperopia with or without astigmatism is a frequent refractive error after cataract surgery. 2,14 Spectacles or contact lenses can correct these errors, but patients, particularly in a growing presbyopic patient population, whose primary aim is correction without spectacle dependence do not welcome such a solution. Thus, surgical intervention remains a strong option for symptomatic overcorrection after a cataract surgery procedure. 10,15 Although LASIK is currently the most popular treatment option for patients with low to moderate hyperopia, 17 CK may offer the advantages of safety and ease. Conductive keratoplasty is minimally invasive, which makes it appealing for the correction of low primary hyperopia and residual hyperopia after refractive corneal and cataract surgery procedures. 8 Lasers reshape the cornea by vaporizing tissue. 10,14 Conductive keratoplasty reshapes the cornea Figure 5. Postoperative CK topography shows the changes. J CATARACT REFRACT SURG - VOL 32, SEPTEMBER

6 Figure 6. Photograph shows the CK corneal applications after cataract surgery without complications. using low-level radio-frequency energy applied to specific spots around the cornea, 7,18 creating a constrictive band that makes the cornea steeper. In addition, CK is more economical than LASIK. As a nonexcimer laser technique for correcting hyperopia, CK preserves the central cornea and does not induce flap-related complications. The range of correction, however, is limited to low hyperopia, and LASIK or other procedures are necessary in patients who are outside the treatment range of CK. 19 With CK, treatment spots of thermal coagulation are visible on slitlamp examination. Conductive keratoplasty delivers energy deep into the stroma rather than on the surface, 19 and the spots appear as small surface leukomas with connecting lines. Our study evaluated the efficacy, safety, stability, and predictability of CK to correct residual hyperopia and hyperopic astigmatism after cataract surgery. The patients were older than those in other published studies of primary CK. 7,8,20 Uncorrected visual acuity is a main criterion to assess the effectiveness of a refractive procedure. 7,10,14,19 In our study, mean UCVA improved after CK, with 62.5% of eyes having a UCVA of 20/40 (0.5) or better at 6 months and 12 months. The safety profile after CK is similar to that after laser thermal keratoplasty, 19,21 probably because the visual axis is preserved in both procedures. In comparison, hyperopic photorefractive keratectomy and hyperopic LASIK studies report a loss of 2 lines or more of BSCVA in 5% to 6% of cases. In our study, only 1 eye (6.25%) lost 2 lines of vision. In a study of CK in virgin eyes by McDonald et al., 19 4% of patients lost 2 lines of BSCVA and 0.5% lost more than 2 lines. We found no statistically significant differences between the mean BSCVA before CK and that after the 12-month follow-up. Six months and 12 months after CK, 75.00% and 81.25% of eyes, respectively, had an SE within G1.00 D of emmetropia. Other studies 19,20 report stable refraction at 6 months. We found that CK after cataract surgery was stable after 6 months postoperatively and there were no statistically significant changes in UCVA between 6 months and 12 months. The 6 month-follow up showed that CK after cataract surgery in pseudophakic middle-aged patients was effective, relatively predictable, stable, and safe in correcting low to moderate residual hyperopia. No IOL-related complications were found when CK was performed 3 months after cataract surgery. REFERENCES 1. O Day DM. Management of cataracts in adults; quick reference guide for clinicians; the Cataract Management Guideline Panel of the Agency for Health Care Policy and Research. Arch Ophthalmol 1993; 111: Høvding G, Natvik C, Sletteberg O. The refractive error after implantation of a posterior chamber intraocular lens. The accuracy of IOL power calculation in a hospital practice. Acta Ophthalmol 1994; 72: Pierro L, Modorati G, Brancato R. Clinical variability in keratometry, ultrasound biometry measurements, and emmetropic intraocular lens power calculation. J Cataract Refract Surg 1991; 17: Snead MP, Rubinstein MP, Hardman Lea S, Haworth SM. Calculated versus A-scan result for axial length using different types of ultrasound probe tip. Eye 1990; 4: Erickson P. Effects of intraocular lens position errors on postoperative refractive error. J Cataract Refract Surg 1990; 16: Sinskey RM, Amin P, Stoppel JO. Indications for and results of a large series of intraocular lens exchanges. J Cataract Refract Surg 1993; 19: McDonald MB, Davidorf J, Maloney RK, et al. Conductive keratoplasty for the correction of low to moderate hyperopia; 1-year results on the first 54 eyes. Ophthalmology 2002; 109: ; discussion by CL Blanton, ; correction, Comaish IF, Lawless MA. Conductive keratoplasty to correct residual hyperopia after corneal surgery. J Cataract Refract Surg 2003; 29: Haw WW, Manche EE. Conductive keratoplasty and laser thermal keratoplasty. Int Ophthalmol Clin 2002; 42(4): Ayala MJ, Pérez-Santonja JJ, Artola A, et al. Laser in situ keratomileusis to correct residual myopia after cataract surgery. J Refract Surg 2001; 17: World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. Edinburgh, Scotland, 52nd General Assembly, October Alió JL, Rodríguez-Prats JL, Galal A, Ramzy M. Outcomes of microincision cataract surgery versus coaxial phacoemulsification. Ophthalmology 2005; 112: J CATARACT REFRACT SURG - VOL 32, SEPTEMBER 2006

7 13. Desai P. The National Cataract Surgery Survey: II. Clinical outcomes. Eye 1993; 7: Norouzi H, Rahmati-Kamel M. Laser in situ keratomileusis for correction of induced astigmatism from cataract surgery. J Refract Surg 2003; 19: Ayala MJ, Claramonte PJ, Sánchez S, et al. Corrección, con láser excimer, de la miopía residual tras cirugía de la catarata. Arch Soc Esp Oftalmol 1997; 72: Beatty J, Cook C, Murdoch I. Refractive error following cataract extraction with the implantation of a standard power intraocular lens in a rural African blindness prevention programme [letter]. Eye 2004; 18: Duffey RJ, Leaming D.U.S. Trends in refractive surgery: 2001 International Society of Refractive Surgery Survey. J Refract Surg 2002; 18: Choi B, Kim J, Welch AJ, Pearce JA. Dynamic impedance measurements during radio-frequency heating of cornea. IEEE Trans Biomed Eng 2002; 49: Asbell PA, Maloney RK, Davidorf J, et al. Conductive keratoplasty for the correction of hyperopia. Trans Am Ophthalmol Soc 2001; 99:79 84; discussion, McDonald MB, Hersh PS, Manche EE, et al. Conductive keratoplasty for the correction of low to moderate hyperopia: U.S. clinical trial 1-year results on 355 eyes; the Conductive Keratoplasty United States Investigators Group. Ophthalmology 2002; 109: ; discussion by DD Koch, Alió JL, Ismail MM, Sanchéz Pego JL. Correction of hyperopia with non-contact Ho:YAG laser thermal keratoplasty. J Refract Surg 1997; 13: Vinciguerra P, Epstein D, Radice P, Azzolini M. Long-term results of photorefractive keratectomy for hyperopia and hyperopic astigmatism. J Refract Surg 1998; 14:S183 S Nagy ZZ, Munkácsy G, Popper M. Photorefractive keratectomy using the Meditec MEL 70 G-scan laser for hyperopia and hyperopic astigmatism. J Refract Surg 2002; 18: Carones F, Gobbi PG, Vigo L, Brancato R. Photorefractive keratectomy for hyperopia; long-term nonlinear and vector analysis of refractive outcome. Ophthalmology 1999; 106: Pérez-Santonja JJ, Sakla HF, Ayala-Espinosa MJ, et al. Queratomileusis in situ con laser excimer (LASIK) para hipermetropía: resultados preliminares. Arch Soc Esp Oftalmol 1999; 74: Cobo-Sobriano R, Llovet F, González-López F, et al. Factors that influence outcomes of hyperopic laser in situ keratomileusis. J Cataract Refract Surg 2002; 28: Lian J, Ye W, Zhou D, Wang K. Laser in situ keratomileusis for correction of hyperopia and hyperopic astigmatism with the Technolas 117C. J Refract Surg 2002; 18: Ditzen K, Fiedler J, Pieger S. Laser in situ keratomileusis for hyperopia and hyperopic astigmatism using the Meditec MEL 70 spot scanner. J Refract Surg 2002; 18: Esquenazi S, Mendoza A. Two-year follow-up of laser in situ keratomileusis for hyperopia. J Refract Surg 1999; 15: J CATARACT REFRACT SURG - VOL 32, SEPTEMBER

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