Title: Intraocular Lenses for Cataract: Clinical and Cost Effectiveness Review Date: October 17, 2007 Context and Policy Issues: A 2006 study estimated that the prevalence of low vision and blindness in the Canadian population to be 35.6 and 3.8 per 10,000 individuals, according to the World Health Organization classification, and 71.2 and 23.6 per 10,000 individuals, using the North American definition. 1 Appendix A highlights descriptions of both categorizations, with the North American definition seeming less restrictive which may account for the discrepancy in the estimation of prevalence. Among individuals with some visual loss (vision worse than 20/40), cataract and visual pathway disease were the common causes, accounting for 40% of visual impairment. In the USA, cataract is the most frequently cited self-reported cause of visual impairment and the third leading cause of preventable blindness. 2 According to the American Optometric Association s Guidelines, cataract is an opafication of the lens that leads to measurably decreased (visual acuity) VA and/or some functional disability as perceived by the patient. Causes of cataract are aging or secondary to hereditary factors, trauma, inflammation, metabolic or nutritional disorder or radiation. 2 Three common types of cataract are nuclear, cortical and posterior subcapsular. 2 Initial treatments for cataract may include changing a spectacle or contact lens prescription to improve vision, incorporating filters into the spectacles to decrease glare disability, advising the patient to wear brimmed hats and sunglasses to avoid the glare and dilating the pupil to allow for viewing with more peripheral areas of lens. 2 Surgery is an option for patients with decreased visual activity to the level that it interferes with the patient s lifestyle and everyday activities, and when satisfactory functional vision cannot be obtained with spectacles, contact lenses or other optical aids. Surgical procedures include extracapsular cataract, extraction by nuclear expression and intracapsular cataract extraction. Cataract extraction with intraocular lenses (IOL) implants leads to improved vision in the majority of patients and leads to better ability to perform daily activities and improved quality of life and mental status. 2 Potential risks associated with surgery include postoperative complications that may result in vision worse than Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.
that prior to surgery or in total vision loss or may require additional medication or prolonged followup. 2 In Ontario, the number of cataract surgeries increased from 44,943 to 109,506 between 1992 and 2004, and the prevalence of cataract increased from 696,963 to 946,857 during the same period. 3 This report provides evidence of the clinical- and cost-effectiveness of foldable IOLs, specifically blue-light filtering, aspheric, multi-focal and accommodating lens. Blue light filtering lenses reduce the eye s exposure to blue light that can damage the retina 4, and aspheric lenses have a complex front surface that gradually changes curvature from the center of the lens all the way out to the edge. In plus (farsighted) lenses, the front surface gradually flattens towards the edge of the lens, and, in minus (nearsighted) lenses, the surface gradually steepens toward the lens edge 5. Multi-focal lenses are corrective lenses with two or more different lens powers to help one focus both near and far 6, and accommodating lenses are lenses designed adjust, like the natural eye, to see at multiple distances 7. Research Question: 1. What is the comparative clinical effectiveness of different types of foldable intraocular lenses [(a) blue light filtering, b) aspheric, c) multi-focal and d) accommodating lens] for patients with cataracts. 2. What is the comparative cost- effectiveness of different types of foldable intraocular lenses [a) blue light filtering, b) aspheric, c) multi-focal and d) accommodating lens] for patients with cataracts. Methods: A literature search was conducted on key health technology assessment resources, including PubMed, The Cochrane Library (Issue 2, 2007), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI s HTAIS, EuroScan, international HTA agencies, and a focused Internet search. Results include English language publications from 1997 to date. Summary of Findings: From the literature search, we identified five randomized controlled trials (RCTs) 8-12 and two economic evaluations 13,14. Appendix B provides details on the RCTs identified on foldable IOLs. Studies were selected if they compared foldable IOL types listed in the research question with at least one alternative IOL and if they measured the clinical-effectiveness of IOLs. IOL types examined were blue light filtering, aspheric, multi-focal, and accommodating lens. The patient population was adults with cataract undergoing surgery. All RCTs evaluated VA, wavefront aberration (imperfections in the way light passes through the eye, which affects the ability to focus properly) 15, glare and contrast testing, haze of vision, accommodation error and refractive error (a disorder where the shape of the eye does not bend light correctly, resulting in blurred image) 16, and/or Nd: YAG laser capsulotomy rate (the disruption of the opacification or cloudiness on the posterior lens capsule) 17. Intraocular Lenses for Cataract 2
Randomized Controlled Trials Blue light filtering One clinical study compared blue light filtering IOLs that were bilaterally implanted with acrylic IOL implantation. No statistically differences were found in the uncorrected VA, best corrected VA and Nd YAG laser capsulotomy rate between the two groups (p>0.05). A high patient satisfaction was reported among 96.6% of patients in the intervention group. 8 Aspheric Author Kershner evaluated the contrast and visual performance of aspheric, silicone and acrylic IOLs. Patients requiring cataract surgery in one eye or both eyes were randomly assigned to receive one of three IOL implantations. The results indicated that there were no statistically differences in the preoperative and postoperative spherical and astigmatic refractive errors and best corrected VA among the study groups. However, the aspheric IOL provided a statistically improvement in retinal contrast and visual acuity and functional acuity contrast testing. The effects were greatest in night vision and night vision with glare. 9 A two-part study measured the wavefront aberration profile of eyes with three different types of IOLs: one aspheric IOL (Tecnis Z9000) and two different acrylic IOLs (Arysof MA60BM and the Sensar Optiedge AR40ev). The findings showed that the implantation of the aspheric IOL led to statistically reduction in spherical aberration of the eye compared with the other study groups. There were no statistically differences in the total order aberrations among the three IOL groups. 10 Multi-focal Authors Javitt et al. compared bilateral implantation of a multi-focal with a mono-focal IOL with respect to visual function, patient satisfaction and quality of life. The results demonstrated that patients with bilateral implants of the multi-focal IOLs obtained better uncorrected and distancecorrected near VAs and reported better overall vision, less limitation in visual function, and less spectacle dependency than patients with bilateral mono-focal IOLs. 11 The differences in outcomes were in mean uncorrected binocular near VA, binocular near VA with best distance correction, with 0.5 (20/40) or better uncorrected binocular distance VA and a Jaeger value of J3 or better uncorrected binocular near VA at the final prospective examination, and with 1.0 (20/20) or better uncorrected binocular near visual acuity. 11 Accommodating lens One study compared the distance and near VA, accommodation amplitude and the presence of corneal multi-focality, a regional variation in corneal curvature potentially created by refractive corneal surgery 18, between the 1CU accommodating lens and the foldable acrylic IOL. The authors concluded that the 1CU IOL restored accommodation and provided additional near visual acuity postoperatively, but the benefit disappeared at 12 months with a concomitant decreased accommodation amplitude as a results of an increase in capsule opacities. 12 Intraocular Lenses for Cataract 3
Economic Evaluations In 2002, authors Orme et al. compared the cost and outcomes of bilateral cataract surgery with the foldable AMOArray multi-focal IOLs versus foldable mono-focal intraocular lens from the health care payer s perspective in Germany. The direct medical costs associated with bilateral cataract surgery were calculated. The outcomes measured were subjective and included a self-rated quality of vision, self-rated degree of satisfaction with vision without spectacles and self-rated limitation in vision related function. Satisfaction with vision was recorded on a scale of 0 to 4, with 0 meaning not all satisfied and 4 meaning extremely satisfied. Limitation with vision was calculated on a reciprocal scale of 0 to 4, with 0 being no limitation and 4 being extremely limited. Quality of vision was measured on a rating scale of 0 to 10. The costeffectiveness of each treatment was determined by dividing the average cost per patient by the proportion of patients experiencing a particular outcome experienced by the patient. Sensitivity analyses were also conducted based on the average number of spectacles required by the patient. The best case scenario assumed that a patient required two pairs of single vision spectacles in total (one pair each for near and distance vision). It is assumed in the worst case scenario that if a patient needs spectacles for near and distance vision, these patients require one pair of multi-focal spectacles. Under this assumption, the total cost of the procedure using the multi-focal IOL will be more than the total cost of the procedure using monofcal lenses. In the base case scenario, the average number of spectacles required is the mid-point between the average number of spectacles required in the worst and best scenarios. The study results are shown for the base case scenario. 13 The results indicated that the average cost per patient per procedure is greater with the multifocal IOL (US$989.83) compared with the mono-focal IOL (US$957.71). The multi-focal IOL was more cost-effective than the mono-focal lens in terms of cost per patient. However, the multi-focal was less cost-effective than the mono-focal lens in achieving vision without glare, halos or rings around the lights. The incremental cost of the multi-focal IOL for a one-point increase was US$29.02 in the self-rated score quality of vision, US$45.76 in satisfaction with day vision, and US$64.17 in satisfaction with night vision. The small additional cost of the multi-focal IOL was outweighed by the increased satisfaction with vision experienced by the multi-focal IOL patients. 13 A 2004 study by Dolders et al. conducted a cost-minimization analysis (CMA) of foldable monofocal IOLs compared with foldable multi-focal IOLs in cataract surgery following a prospective, multicentre RCT. The RCT and CMA were carried out at separate times. A societal perspective was adopted, where direct health care and non-health care costs and the indirect costs were considered. The clinical outcomes measured were VA in logmar and postoperative refraction error in spherical equivalents (SE). 14 The findings showed that VA was not ly different between the two groups. The monofocal group showed a myopic SE compared with the multi-focal group at 1-2 weeks before first eye surgery (p<0.01) and at 3 months after the first eye surgery (p<0.01). The exchange rate for the study period varied from 1 = 0.85US$ to 1 = 1.07US$. The mean costs for glasses per patient in mono-focal group were 41.67 and 149.58 in the multi-focal group. The difference was statistically (p=0.008). No differences were found in total costs or in clinical effectiveness between the mono-focal and multi-focal IOL groups. The study results demonstrated that the savings in the direct patient costs compensate for the additional direct healthcare costs for the multi-focal IOL group since patients spent less on non-refractive glasses (Mono-focal: mean = 241.67, SD = 219.91versus multi-focal: mean = 149.58, SD = Intraocular Lenses for Cataract 4
185.01). It concluded that the use of multi-focal IOLs in cataract surgery resulted in a decrease in costs of patient s postoperative spectacle. 14 Conclusions and Implications for Decision or Policy Making: Our search identified five RCTs and two economic evaluations on foldable IOLs. The studies have shown that aspheric and multi-focal IOLs are more clinically effective compared with their alternatives in the trials; however, we do not know their efficacies across all foldable IOL types. Multiple outcomes were measured across the studies, but visual acuity was assessed in all RCTs in the report. Results must be interpreted with caution due to study limitations outlined in Appendix B. Such limitations include small sample size, follow-up durations, differences in clinical characteristics among patient groups, and lack of harm data. Findings in one economic evaluation suggested that multi-focal lens may be slightly more costly from a health care payer s perspective, but it is outweighed by increased satisfaction with vision reported by multi-focal IOLs patients. Also, multi-focal IOL implants resulted in ly decreased costs from a patient s perspective. It is noteworthy that both economic studies were carried out in Europe, and one study used subjective clinical outcomes as part of the cost-effectiveness analysis. 13 Prepared by: Julie Polisena, MSc, Research Officer, HTA Emanuel Nkansah, MLS, MA, Information Specialist Health Technology Inquiry Service Email: htis@cadth.ca Tel: 1-866-898-8439 Intraocular Lenses for Cataract 5
References: 1. Maberley DA, Hollands H, Chuo J, Tam G, Konkal J, Roesch M, et al. The prevalence of low vision and blindness in Canada. Eye 2006;20(3):341-6. 2. Murrill CA, Stanfield DL, VanBrocklin MD, Bailey IL, DenBeste BP, DiIorio RC, et al. Optometric clinical practice guideline: care of the adult patient with cataract. St. Louis (MO): American Optometric Association; 2004. Available: http://www.aoa.org/documents/cpg-8.pdf (accessed 2007 Oct 11). 3. Rachmiel R, Trope GE, Chipman ML, Buys YM. Cataract surgery rates in Ontario, Canada, from 1992 to 2004: more surgeries with fewer ophthalmologists. Can J Ophthalmol 2007;42(4):539-42. 4. Reddy P, Gao X, Barnes R, Fairchild C, Boci K, Waycaster C, et al. The Economic Impact of Blue Light Filtering Intraocular Lenses on Age-Related Macular Degeneration Associated with Cataract Surgery[poster]. International Society for Pharmacoeconomics and Outcomes Research (ISPOR 2006) Annual International Meeting; 2006 May 20; Philadelphia, PA. Available: http://www.abtassociates.com/posters/reddyp_poster_ispor2006.pdf (accessed 2007 Oct 16). 5. Bruneni JL. Aspheric Lenses for Better Vision and Appearance [web site]. In: All About Vision. La Jolla, CA: Access Media Group, LLC; 2006. Available: http://www.allaboutvision.com/lenses/aspheric-lenses.htm (accessed 2007 Oct 16). 6. Multi-focal lenses [web site]. In: Encyclopedia. Apollo Beach, FL: LaserMyEye, Inc; 2004. Available: http://www.lasermyeye.org/encyclopedia/multifocallens.html (accessed 2007 Oct 16). 7. What are Accommodating IOL's? (Intra-Ocular-Lenses) [web site]. In: AccommodatingIOL.com; 2007. Available: http://www.accommodatingiol.com/ (accessed 2007 Oct 16). 8. Barišiæ A, Dekaris I, Gabriæ N, Bosnar D, Laziæ R, Martinoviæ ZK, et al. Blue light filtering intraocular lenses in phacoemulsification cataract surgery. Coll Antropol 2007;31(Suppl 1):57-60. 9. Kershner RM. Retinal image contrast and functional visual performance with aspheric, silicone, and acrylic intraocular lenses. Prospective evaluation. J Cataract Refract Surg 2003;29(9):1684-94. 10. Padmanabhan P, Rao SK, Jayasree R, Chowdhry M, Roy J. Monochromatic aberrations in eyes with different intraocular lens optic designs. J Refract Surg 2006;22(2):172-7. 11. Javitt J, Brauweiler HP, Jacobi KW, Klemen U, Kohnen S, Quentin CD, et al. Cataract extraction with multifocal intraocular lens implantation: clinical functional, and quality-of-life outcomes: multicenter clinical trial in Germany and Austria. J Cataract Refract Surg 2000;26(9):1356-66. Intraocular Lenses for Cataract 6
12. Dogru M, Honda R, Omoto M, Toda I, Fujishima H, Arai H, et al. Early visual results with the 1CU accommodating intraocular lens. J Cataract Refract Surg 2005;31(5):895-902. 13. Orme ME, Paine AC, Teale CW, Kennedy LM. Cost-effectiveness of the AMOArray multifocal intraocular lens in cataract surgery. J Refract Surg 2002;18(2):162-8. 14. Dolders MG, Nijkamp MD, Nuijts RM, van den BB, Hendrikse F, Ament A, et al. Cost effectiveness of foldable multifocal intraocular lenses compared to foldable monofocal intraocular lenses for cataract surgery. Br J Ophthalmol 2004;88(9):1163-8. Available: http://bjo.bmj.com/cgi/content/full/88/9/1163 (accessed 2007 Sep 28). 15. Wavefront aberrations [web site]. In: Encyclopedia. Apollo Beach, FL: LaserMyEye, Inc; 2004. Available: http://www.lasermyeye.org/encyclopedia/aberrations.html (accessed 2007 Oct 16). 16. Refractive Errors [web site]. In: Eye Conditions. Ann Arbor, MI: University of Michigan Kellogg Eye Center; 2007. Available: http://www.kellogg.umich.edu/patientcare/conditions/refractive.errors.html (accessed 2007 Oct 16). 17. Hayden M. Nd:YAG laser posterior capsulotomy for cataracts [web site]. In: Kaiser Permanente [Health encyclopedia]. Oakland, CA: Healthwise, Incorporated; 2005. Available: http://members.kaiserpermanente.org/kpweb/healthency.do?hwid=hw36757&rop=mrn (accessed 2007 Oct 16). 18. Oshika T, Mimura T, Tanaka S, Amano S, Fukuyama M, Yoshitomi F, et al. Apparent Accommodation and Corneal Wavefront Aberration in Pseudophakic Eyes. Investigative Ophthalmology and Visual Science 2002;43:2282-886. Available: http://www.iovs.org/cgi/content/full/43/9/2882 (accessed 2007 Oct 16). Intraocular Lenses for Cataract 7
Appendix A: Categorizations of Visual Loss Based on the Better Seeing Eye 1 World Health Organization Category Definition 0-Normal vision 20/25 or better 0-Near normal vision 20/30-20/60 1-Moderate low vision 20/70-20/160 2-Severe low vision 20/200-20/400 3-Profound vision loss (blindness) 20/500-20/1000 or visual field < 10 degrees 4-Near total vision loss (blindness) <20/1000 or visual field <5 degrees 5-Total vision loss (blindness) No light perception North America Category Definition Not impaired Better than or equal to 20/40 Low vision Worse than 20/40 but better than 20/200 Blind 20/200 or worse Intraocular Lenses for Cataract 8
Appendix B: Clinical Effectiveness and Harm of Foldable Intraocular Lenses for Cataracts Study (Author, Study Year, Country) Design Barišiæ et al., Prospective, 2007, Croatia 8 randomized comparative study with a 6-month follow-up 30 participants with cataract. Patients with glaucoma, retinal, or any other severe ocular pathology were excluded from the study. Group 1: Blue light filtering intraocular lens that was bilaterally implanted (n=30; 60 eyes) Group 2: Conventional AcrySof MA60BM IOL implantation (n=30; 60 eyes) 1. Uncorrected VA 2. Best corrected VA 3. Nd YAG laser capsulotomy rate 1. No statistically differences between both groups were found (p=0.793). Uncorrected VA better than 0.8 (20/25) was achieved in 86.7% patients in Group 1 compared with 85% in Group 2 A larger sample size and longer follow-up period may be required to make the comparison more conclusive. 2. All patients in both groups achieved best corrected VA better than 0.8 (20/25) Kershner, 2003, USA 9 6-month randomized, prospective study Patients who required cataract surgery in one eye or both eyes Group 1 (n=105 eyes of 64 patients): 1-piece silicone Group 2 (n=41 eyes of 27 patients): 1-piece acrylic 1. Preoperative best corrected VA 2. Postoperative uncorrected VA 3. Nd YAG laser capsulotomy rate was low, and there were no statistically difference between both groups 1. The mean preoperative best corrected VA in all patients was 20/265 ± 23 (SD) (range 20/50 to counting fingers); Present study did not control for pupil size or for IOL type or style as the 3 lenses tested were intentionally different Intraocular Lenses for Cataract 9
Study (Author, Year, Country) Study Design Group 3 (75 eyes of 65 patients): 3-piece aspheric 3. Preoperatively and postoperatively mean refractive error 4. Functional acuity contrast testing (FACT) 5. Photopic contrast with glare 6. Contrast for night (mesopic) levels with glare testing there was no statistically differences among the groups 2. There was a statistically difference in mean uncorrected VA from 3 to 6 months between the aspheric group (20/25 ± 2) and the silicone (20/36 ± 1) and acrylic ( 20/30 ± 1) groups (p<0.001) 3. The difference among groups was not statistically 4. The aspheric group had increased contrast sensitivity at all spatial frequencies under photopic conditions 5. All 3 IOL groups had a 38% improvement in contrast over Intraocular Lenses for Cataract 10
Study (Author, Year, Country) Study Design preoperative values at spatial frequencies of 1.5, 3.0 and 6.0 cycles per degree. There was no statistically difference among the 3 IOL groups Padmanabhan et Part 1: al., 2006, USA 10 Randomized open study Part 2: Wavefront aberrations of 16 eyes that underwent an identical surgical as in Part 1 but or Sensar Optiedge AR40e IOL 16 patients with bilateral cataract who underwent bilateral phacoemulsification with a foldable IOL in the capsular bag Group 1: Tecnis Z9000 IOL was implanted one eye (aspheric) Group 2: Acrysof MA60BM IOL was implanted on the other eye (acrylic) 1. Wavefront aberrations of each eye, 2 weeks after surgery 2. Waverfront aberrations of Optiedge AR40e group compared with the Tecnic Z9000 results and Acrysof MA60BM IOL results 6. Differences in contrast for high (mesopic) levels with glare testing at 1.5, 3.0 and 6.0 cycles per degree among the silicone and acrylic groups and preoperative values were not statistically 1. 16 patients showed a statistically ly lower magnitude of spherical aberration in the eye with the Tecnis IOL as compared with the fellow eye 2. The mean spherical aberration in the A larger sample size and an intra-individual study may be required to make the comparison more conclusive. Intraocular Lenses for Cataract 11
Study (Author, Year, Country) Study Design implantation were studied and compared with eyes with the Tecnis Z9000 and Acrysof MA60BM IOLs Sensar Optiedge AR 40e group was 0.20±0.09 μm as compared with the corresponding value in the Tecnis group of 0.07±0.12 μm (p=0.002) 3. No statistically differences were reported between Sensar Optiedge AR40e IOLs and Acrysof MA60BM IOLs Javitt et al., 2000, Germany and Austria 11 Prospective, randomized masked clinical trial 124 patients who had a bilateral implantation Group 1: multi-focal IOL (n=64) Group 2: mono-focal IOL (n=54) 1. Uncorrected binocular distance visual acuity 2. Best corrected binocular distance visual acuity 3. Uncorrected binocular near visual acuity 4. Binocular near visual acuity with best distance correction 4 of 16 eyes in the Tecnis group had a negative spherical aberration postoperatively. 1. No between-group difference in mean uncorrected binocular distance visual acuity. Mean uncorrected binocular distance visual acuity was 1.0 (20/21) in Group 1 and 0.9 (20/22) in Group 2 2. No 1. Patients who enroll may differ from the general population in health status, personality, and attitudes towards medical care. 2. Patients in both groups were comparable in terms of demographics, lack of ocular comorbidity, Intraocular Lenses for Cataract 12
Study (Author, Year, Country) Study Design 5. Binocular near visual acuity with best distance correction 6. Combined visual acuities 7. Mean refractive results difference between-group difference in mean corrected distance visual acuity. Group 1 achieved a mean binocular corrected distance visual acuity of 1.1 (20/18) and Group 2 of 1.2 (20/17) postoperative best corrected acuity, surgical approach and IOL characteristics, but not in terms of multifocality. 3. A statistically difference (p<0.001) was found between both groups and 86.8% (46/53) in mean uncorrected binocular near VA: 0.8 (20/25) in the multi-focal group and 0.5 (20/41) in the mono-focal group 4. A statistically difference was found between Group 1 and Group 2 (p<0.001) for binocular near VA with best distance correction, with Intraocular Lenses for Cataract 13
Study (Author, Year, Country) Study Design means of 0.8 (20/26) and 0.4 (20/46), respectively 5. No statistically difference between Group 1 and Group2 was found in mean binocular near VA with best distance correction and additional add power 6. A statistically difference was achieved between groups with 0.5 (20/40) or better uncorrected binocular distance visual acuity and J3 or better uncorrected binocular near visual acuity at the final prospective examination (p<0.001). Combined distance and near VAs of 0.5 (20/40) or better and a Jaeger value of J3 Intraocular Lenses for Cataract 14
Study (Author, Year, Country) Study Design or better were achieved by 96.7% (59/61) in Group 1 and 66.0% (35/53) in Group 2. A statistically difference was achieved between groups with 1.0 (20/20) or better uncorrected binocular near visual acuity (p<0.001). 55.7% in Group 1 and 13.2% (7/53) in Group 2 7. No statistically difference was found between groups in the mean spherical equivalent after either first or second IOL implantation, with mean results ranging from -0.27 to -0.51 D. No statistically difference in mean scores was found for refractive Intraocular Lenses for Cataract 15
Study (Author, Year, Country) Study Design cylinder for firsteye implantation, with a mean score of 0.40 D in Group 1 and 0.47 D in Group 2. A difference (p=0.011) was found between groups in secondeye implantation, with Group 2 having a higher mean refractive cylinder (0.60D) than Group 1 Dogru et al., Randomized 2005, Japan 12 clinical trial 26 patients with corticonuclear cataracts had small-incision clear corneal cataract surgery. Group 1: 1CU Accommodating IOL Group 2: foldable acrylic IOL (AcrySof MA60BM) 1. Distance visual activity 2. Contrast visual acuity 3. Near visual acuity 4. Accommodative response and capsule opacity 5. Amplitude of accommodation One adverse event was a lens exchange in the second eye implanted with a multi-focal lens. 1. No statistically differences between the mean uncorrected VA and best corrected VA scores at any examination (p>0.05) 2. No statistically differences in relation to the Long-term studies with a larger patient population may be necessary to accurately measure the effect of intraoperative peripheral capsule polishing on the accommodative capacity of 1CU accommodating IOLs. Intraocular Lenses for Cataract 16
Study (Author, Year, Country) Study Design 6. Intraocular pressure and corneal endothelial cell density mean contrast visual acuity scores measured with the high contrast and reverse polarity charts as well as intermediate and low-contrast charts at 12 months between 2 IOL groups (p>0.05) 3. No statistically differences in best corrected near VA scores between both groups at all examination points in eyes implanted (p>0.05) 4. In Group 1, the accommodometer displays revealed an accommodative response in 3 of 22 eyes (14%) at the first postoperative week followed by 4 eyes (18%), 13 eyes (62%), 14 eyes (66%), and 3 eyes (14%) at the 1-month, 3-month, Intraocular Lenses for Cataract 17
Study (Author, Year, Country) Study Design 6-month, and 12- month follow-up visits 5. A time-wise decrease in accommodation amplitude was observed in patients who received 1CU accommodating IOL. The increase in the amplitude at 3 and 6 months was statistically (p<0.05) 6. The differences in the preoperative and postoperative endothedial cell counts were not (p0>0.5). The difference in the mean intraocular pressure was not statistically between both groups (p>0.05) Intraocular Lenses for Cataract 18