Title: Macular Translocation Surgery for Patients with Age-Related Macular Degeneration: Clinical and Cost-Effectiveness Review

Transcription

1 Title: Macular Translocation Surgery for Patients with Age-Related Macular Degeneration: Clinical and Cost-Effectiveness Review Date: 08 November 2007 Context and Policy Issues: In North America, age-related macular degeneration (AMD) remains the single most common cause of legal blindness in individuals over 65 years old. 1 In general, AMD is the third most common cause of visual impairment in Canada. 2 The macula is the part of the retina that provides central vision. 3 There are two forms of AMD: dry or atrophic and wet or neovascular. 4 AMD is characterized by the thinning of the macula retina, and wet AMD is characterized by the growth of new vessels in the choroid layer underneath the retina, which threaten vision if they leak and cause scarring. 3 Ninety percent of people with AMD have dry macular degeneration, and 10% have wet macular degeneration. 3 Based on a 2005 study, an estimated 180,000 new cases of dry AMD and 17,000 new cases of wet AMD occur in Canada annually. 4 The prevalence of AMD increases with age. Overall, 1.47% of people over the age of 40, or approximately 1.75 million people in the USA, have AMD and approximately 1.25 million have the neovascular variant. The number of cases of neovascular AMD in the USA is expected to rise to million by the year AMD may have a detrimental effect on the quality of life of the people inflicted with the disease as well as adverse effects on the overall economy. 4 The annual GDP of the USA for 2003 was $ trillion, and AMD may result in a potential loss of close to $30 billion or 0.27% of the GDP. The 2003 GDP of Canada was $958.7 billion. Extrapolation of the US data to Canada suggests that AMD may cause a $2.6 billion loss to the Canadian economy annually. 4 Laser therapy is used to coagulate new vessels in neovascular macular degeneration. The procedure is associated with risks, such as permanently impaired vision, especially if the vessels are very close to the fovea. Recurrence is common, and laser therapy may be most effective in people with classic neovascular macular degeneration compared with occult neovascular macular degeneration 3 Other new treatments for AMD include surgery to remove new vessels, radiotherapy, photodynamic therapy and new drugs that suppress vessel formation (antiangiogenic drugs). 3 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.

2 Macular translocation involves moving the macula so that the fovea lies over a healthier part of the choroid. This may involve detaching and rotating the retina (macular translocation with 360 o retinotomy), or making an incision in the retina, folding the outer layers of the eye, making the sclera shorter and moving the choroid slightly in relation to the macula (limited macular translocation). 3 If the retina is detached, silicone oil tamponade is used for reattachment. This report provides evidence of the clinical-effectiveness and harm of macular translocation surgery. Research Questions: 1. What are the comparative clinical effectiveness and safety of macular translocation surgery for patients with AMD? 2. What is the comparative cost-effectiveness of macular translocation surgery for patients with AMD? Methods: A literature search was conducted on key health technology assessment resources, including PubMed, Embase via Ovid, The Cochrane Library (Issue 3, 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 articles published between 2002 and the present, and are limited to English language publications only. Filters were applied to limit the retrieval to systematic reviews, meta-analyses, health technology assessments, randomized controlled trials, economic studies and observational studies. Summary of Findings: From the literature search, we identified one meta-analysis 5, one randomized-controlled trial (RCT) 6 and seven observational studies No economic evaluations or literature on the costeffectiveness of this intervention were identified. Appendix A provides details on the RCT and observational studies selected on macular translocation for the treatment of AMD. Studies were selected if they measured the clinical-effectiveness or harm of macular translocation for patients with AMD. In all studies selected, macular translocation with 360 o peripheral retinectomy (MT360) was performed. Clinical outcomes measured include visual acuity (VA), reading speed, contrast sensitivity, colour vision, vision targeted quality-of-life (QoL), arm-retina time (time elapsed between injection of the dye into the anticubital vein and its appearance at these points) 14, and arteriovenous passage time (time elapsed between the appearance of dye at the reference point in the temporal arteries and an adjacent point in the corresponding vein). 14 Health Technology Assessments, Systematic Reviews and Meta-analyses One meta-analysis summarized and discussed the results of four main submacular surgical procedures for AMD. They include: the removal of subretinal choroidal neovascularization (CNV), macular translocation, pigment epithelium transplantation, and the removal of subretinal hemorrhage. 5 The mean best corrected preoperative and final VA and the total number of observed events and percentages with preoperative and final VA 20/200 or better were extracted from each study. The primary outcomes assessed were the proportion of patients with two or more lines of improvement in VA and proportion with two or more lines of deterioration in VA after surgery. 5 Overall rates were calculated from a model only adjusting for the treatment factor. These rates were contrasted with the total number of observed events over the total number of patients in these studies. The simple average of rates observed in the Macular Translocation Surgery for AMD 2

3 individual studies was also calculated. The author analyzed the main outcome variable VA after surgery with three parameter values: improvement, stability and deterioration. 5 Eighty-eight studies met the inclusion criteria, and 1,915 cases were analyzed. The surgical procedures performed were removal of subfoveal CNV in 35% (31 studies), macular translocation in 36% (32 studies), pigment epithelium transplantation in 10% (9 studies), and removal of subretinal hemorrhage in 18% (16 studies). 5 The treatment-specific estimates and 95% confidence intervals for improvement of VA for macular translocation are as follows: Model based=0.31 (0.22,0.39), overall rate=0.33 (0.29,0.36) and average of rates=0.34 (0.25,0.42). The results for deterioration of VA are as follows: Model based=0.27 ( ), overall rate=0.29 ( ) and average of rates=0.29 ( ). 5 Results for stability measurement were not reported. Macular translocation presents the most sufficient minimum follow-up with 66% of the included studies showing a minimum follow-up of either 6 or 12 months. Also, the overall recurrence rate was 16%. 5 Complications were seen in 71% (range:8-100%) of case series for macular translocation. For the other treatments, complications ranged from 39%- 60%. 5 The adverse events were not specified in the meta-analysis. The meta-analysis had some limitations. Results of the subgroup analysis according to duration of follow-up and number of cases included showed no significant influence on the treatment outcome and could not be used to substantiate the quality of the results of this meta-analysis. Comparing results was difficult due to the variation in follow-up time, number of cases and preoperative VA. Also, the results were influenced by the evolving surgical techniques and the varying outcome measures. 5 It was difficult to accurately compare the results of the four different treatments without adjusting for differences in the patient populations receiving those treatments, especially with respect to disease characteristics, such as type, size and location of choroidal neovascularization. Due to the lack of data, only mean values regarding these factors could be calculated for each treatment group. As a result, it was not possible to demonstrate the superiority of one of the four treatment groups. 5 Randomized Controlled Trials Authors Lüke et al. compared the best corrected VA and QoL of MT360 with photodynamic therapy in a prospective, randomized pilot-trial. 6 The study used the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). The NEI VFQ-25 is composed of 25 questions that address twelve subscales that can be grouped together in three broad categories. The first category is the general health subscale. The next category is comprised of five subscales that address the quality of a subject s vision, including general vision, difficulty with distance tasks, difficulty with near tasks, peripheral vision, and colour category. The third category is comprised of six subscales that assess a subject s vision-specific QoL, including dependency, role limitations, mental health, social function, driving, and ocular pain. 13 Results showed a statistically significant improvement in the subscale scores for general vision (p=0.03), mental health (p=0.02) and dependency (p=0.03) in the MT360 group compared with photodynamic therapy. Other outcomes measured, such as vision loss of <3 ETDRS lines or 3-5 ETDRS lines were not statistically significant (p>0.05). Observational Studies Results in all consecutive, interventional case series comparing the preoperative and postoperative clinical outcomes indicated an improvement or no change in the clinical Macular Translocation Surgery for AMD 3

4 effectiveness of MT Complications were reported in five studies and are outlined in Table 1. 7,9,10,12,13 Appendix B provides descriptions of tests used in these studies. One study examined the impact of MT360 on near-vision skills with standardized tests given to 25 patients. 7 Tests included: distance acuity using the Submacular Surgery Trials (SST) protocol and Bailey-Lovey charts, near acuity with the sensitivity using the Lighthouse chart, timed reading speed using Sloan cards, contrast sensitivity using the LEA near-contrast cards and colour vision using the Precision Vision (PV)16 discs. Preoperative outcomes were assessed and compared with postoperative outcomes. Results indicated a statistically significant improvement for near VA, reading speed and contrast sensitivity both at six months and at one year (p<0.05). 7 Lüke et al. evaluated potential electro-oculograph (EOG) change after MT360 in 30 patients with subfoveal choroidal neovascularization secondary to AMD. 8 EOG is a technique for measuring the resting potential of the retina. 15 EOG recordings were done one day prior to the translocation surgery and no earlier than three weeks after the silicone removal applied during surgery. The EOG was recorded in accordance with the International Society for Clinical Electrophysiology of Vision (ISCEV) standards, clinical protocols for electrophysiological examinations. 16 The best-corrected VA was measured by Early Treatment Diabetic Retinopathy (ETDRS) charts using line assessment and the forced choice method. Both outcomes showed a statistically significant postoperative improvement at twelve months (p<0.05). 8 Authors Mruthyunaya et al. 9 and Lai et al. 10 sought to measure visual outcomes following MT360 in patients with subfoveal choroidal neovascularisation secondary to AMD in separate studies. Both studies had the same eligibility criteria, intervention and outcomes measured. Visual outcomes analyzed in both studies include: near and distance VA and reading speed. Lai et al. measured outcomes preoperatively and postoperatively at six and twelve months 10 and Mruthyunjaya et al. measured outcomes preoperatively and at twelve months after surgery. 9 VA was measured using Bailey-Lovey charts with standardized refraction and VA protocols adapted from the Submacular Surgery Trials, and evaluation of reading speed was performed using the Submacular Surgery Trials reading cards. Outcome results varied between the two studies at twelve months, as seen in Table 1. The discrepancy may be due to the different sample sizes (n=15 10 and n=64 9 ). One study compared the retinal circulation times before and after MT A control group of patients who had not undergone any intraocular surgery was also evaluated. 11 A minimally invasive technique, scanning laser fluoresein angiography was used to measure the retinal circulation. The results suggest no statistically significant difference in the outcomes between the study group (preoperative and postoperative) and the control group (p>0.05). 11 Authors Mruthyunjaya et al. evaluated the relationship between preoperative lesion size and composition and visual outcomes at one year after MT360 for patients with bilateral neovascular AMD treated with MT360 in the eye with more recent vision loss. 12 All patients underwent a complete ophalmologic examination before the procedure. Best-corrected distance VA was measured using retroilluminated Bailey-Lovey charts with standardized refraction and VA protocols adapted from the Submacular Surgery Trials. Best corrected near VA was tested using a diopter addition to the distance correction with a Rosenbaum near-vision card under standard lighting. Lesion size was measured using the standard Macular Photocoagulation disk area (MPS DA) templates on fluorescein angiogram negatives from a Zeiss 30 o image or Topcon 35 o image. After all lesions were graded, they were assigned Macular Translocation Surgery for AMD 4

5 into three categories by size: small ( 4 MPS DAs), medium (>4-9 MPS DAs) and large (>9 MPS DAs). Patients were divided into three groups based on lesion size. The findings suggest no statistically significant differences in distance and near VAs and reading speed among the three groups of lesion size (p>0.05). 12 One study evaluated the QoL associated with VA and reading speed after MT360 for AMD using NEI VFQ Authors Cahill et al. also compared the preoperative and postoperative scores using Medical Outcomes 12-item short-form (SF-12). 13 SF-12 is composed of twelve questions that address eight general health subscales including physical functioning; role, physical; bodily pain; general health; energy/fatigue (or vitality); social functioning; role, emotional; and mental health. Thirty-five indicator variables are created from the answers to the SF-12 questions, and each indicator variable is then multiplied by physical and mental regression weights, derived from the general United States population, to generate the physical composite score and mental composite score, respectively. The composite scores are then transformed to a 100-point scale in which 100 represents the best possible score and 0, the worst. 13 Overall, mean postoperative near VA and overall mean postoperative reading speed were significantly better than the overall mean preoperative values (p<0.05). There were no statistically significant differences in the preoperative and postoperative SF-12 scores. The findings indicated a significant overall improvement in QoL for MT Conclusions and Implications for Decision or Policy Making: Our literature search identified one meta-analysis 5, one randomized-controlled trial 6 and seven observational studies No economic evaluations were identified. The study results demonstrated an improvement or no change with MT360 in the clinical outcomes measured for patients with AMD. Visual acuity and reading speed were the primary outcomes measured in most studies in the report. The most common adverse effects associated with MT360 are cystoid macular edema development and recurrent CNV. Findings must be interpreted with caution due to study limitations, such as small sample size and no control group. Preoperative and postoperative clinical outcomes were compared to measure effectiveness; therefore, it remains unknown if MT360 is more clinical effective compared with alternative treatments. One randomized controlled pilot-trial found results for best corrected VA and vision targets QoL favouring MT360 over photodynamic therapy. 6 Prepared by: Julie Polisena, MSc, Research Officer, HTA Monika Mierzwinski-Urban, B.A., M.L.I.S., Information Specialist Health Technology Inquiry Service htis@cadth.ca Tel: Macular Translocation Surgery for AMD 5

6 Appendix A: Clinical Effectiveness and Harm of Macular Translocation Surgery for AMD (Author, RCT Lüke et al. (2007) Germany 6 Prospective, randomized, controlled, non-masked, monocenter pilot-trial study One year follow-up 50 patients with classic subfoveal CNV secondary to AMD 90% (n=5) of the enrolled patients could not be examined at the month-12 examination because of illness or death Group 1 (n=25): Full macular translocation Mean age =79.1±6.47 years (range 65-91) Group 2 (n=25): Photodynamic therapy Mean age =75.7±5.75 years (range 65-87) 1. Best corrected VA 2. Vision targeted QoL 1. The difference in moderate vision loss (3-5 ETDRS lines) was not statistically significant (p=0.25), and the difference in vision loss less than 3 ETDRS lines was not statistically significant (p=0.35). The difference of a gain of 3 or more ETDRS lines of VA from baseline was statistically significant between both groups favouring the MT360 (p<0.01) Small sample size QoL self-reported outcomes were subjective 2. After 1 year, the results of the QoL scores indicate an improvement of the subscale scores general vision (p=0.03), mental health (p=0.02) and dependency (p=0.03) were significantly higher in the MT360 arm Macular Translocation Surgery for AMD 6

7 (Author, Adverse events: Observational studies Toth et al. (2004) Prospective USA 7 study with a 6-month and 1-year followup 25 (F=16 and M=9) consecutive patients with AMD and loss of vision in the fellow eye undergoing macular translocation surgery Macular translocation surgery No comparator was included 1.Distance VA 2. Near VA 3.Reading speed 4.Contrast sensitivity 5. Colour vision Diplopia was noted in 5 patients in the MT360 group, in which the diplopia was intermittent and tolerated well in 4 patients. Eight patients had tilted vision. Two of them were free of the symptom after adoption of prismatic glasses and the remaining 5 patients felt tilted vision not disturbing. One patient developed compensatory head position. 1. The difference in the mean change in distance acuity change from the preoperative acuity was not significant (p=0.89 for 6 months and p=0.32 for 1 year) Median age = 77 years (range years) 2. The change in near VA was significant both at 6 months and at 1 year (p<0.001) Macular Translocation Surgery for AMD 7

8 (Author, 3. The change in reading speed was statistically significant at 6 months (p=0.013) and 1 year (p=0.001) 4. The change in contrast sensitivity was statistically significant at both 6 months and 1 year (p<0.001) 5. The change in color vision was not significant at either 6 months or 1 year (p=0.09 for 6 months and p=0.12 for 1 year) Adverse events: The following complications occurred during the study: 28% of patients had cystoid macular edema found on fundus examination, fluoresce in angiography, or optical coherence tomography; 36% had recurrent choroidal neovasculaization with extension into the fovea in 20%; 28% Macular Translocation Surgery for AMD 8

9 (Author, Lüke et al. (2003) Germany 8 Prospective consecutive case series A consecutive series of 30 (F=18 and M=12) patients suffering from subfoveal choroidal neovascularization secondary to AMD underwent 360 o retinotomy and macular translocation Inclusion criteria: 1. Age 60 years or older 2. Best-corrected VA between 20/40 and 20/200 in the eligible eye 3. AMD with new or recurrent subfoveal CNV or 360 o retinotomy and macular translocation No comparator was included 1. Functional state of the photoreceptor-retinal pigment epithelium complex through an EGO 2. Visual acuity had epiretinal membrane. Three patients had at least one subretinal droplet of perfluorocarbon liquid, although none was in the fovea; and no patient had a macular fold. There were two retinal detachments involving the inferior retinal margin without macular detachment. 1. Postoperatively, a statistically significant decrease in mean dark trough to 24 μv was found for the treated eye (p<0.001), equivalent to a reduction to 64%. The postoperative difference between treated and untreated fellow eyes was also statistically significant (p<0.001) 2. At study enrollment and at 12months post-surgery the difference in VA was statistically significant (p=0.002; p=0.004) No patient adverse events were reported Macular Translocation Surgery for AMD 9

10 (Author, Mruthyunjaya et al. (2004) USA 9 A prospective, interventional, consecutive, noncomparati ve case series Follow up at 12 months subfoveal haemorrhages secondary to CNV 64 patients with bilateral vision loss from neovascular AMD Macular translocation with 360 o retinectomy and silicone oil tamponade No comparator was included 1. Distance acuity letter score 2. Near acuity 3. Reading speed 1. Median distance acuity letter score improved from 62 letters (Snellen equivalent of approximately 20/125) before surgery to 69 letters (approximately 20/80) by 12 months after surgery (p=0.03). 2. Median near acuity improved from 0.70 logmar units (approximately 20/55) at 12 months (p<0.001). 3. Median reading speed improved from 71 words per minute (wpm) before surgery to 105 wpm at 12 months after surgery (p<0.001) Adverse events: 43 patients (67%) had at least 1 complication during the 12-month follow-up period. Cystoid macular Macular Translocation Surgery for AMD 10

11 (Author, Lai et al. (2002) USA 10 A prospective consecutive interventional, noncomparati ve case series Follow-up at 6 months and at 12 months 15 consecutive patients with subfoveal CNV secondary to AMD. Their ages ranged from 71 to 84 years (median age, 76 years) Inclusion criteria: 1) age 55 years or older 2) AMD with subfoveal CNV of any type 3) Best-corrected Snellen VA between 20/50 and 20/400 in the surgically treated Macular translocation with 360 o peripheral retinectomy and silicone oil tamponade No comparator was included 1. Near VA 2. Distance VA 3. Reading speed edema (41%) epiretinal membrane formation (22%), and recurrent CNV (21%) were the most frequently observed events. All 5 retinal detachments were reattached successfully, with 1 additional vitreoretinal surgery with silicone oil tamponade. The silicone oil was removed subsequently, and the retina remained attached. 1. The median near VA logmar score improved significantly from 0.54 units to 0.40 units (p=0.02) at the 6-month follow-up and stabilized at 0.54 (12 months postoperatively) 2. Median preoperative distance VA (20/100) was maintained at both the 6-month and 12-month examinations. Small sample size Macular Translocation Surgery for AMD 11

12 (Author, eye 4) Maximum of 6 months of loss of central vision 3. Seven (54%) of 13 patients and 7(58%) of 12 patients achieved reading speeds of 70 words/min or greater at the 6-month and 12-month postoperative visits Adverse events: Cekic et al (2004) Japan 11 A prospective comparative study 17 patients with subfoveal choroidal neovascularization secondary to AMD Group 1 (n=9): FMT360 o ; patients ages ranged from 55 to 79 years (average, 67.4 years) Group 2 (n=8): No intraocular intervention; patients ranged from 65 to 78 years 1. Arm-retina time 2. Arteriovenous passage time No retinal detachments, proliferative vitreoretinopathy, or macular folds developed in this series of patients. The most common postoperative complications were the development of cystoid macular edema in edema in 3 patients (20%) and piretinal membrane in 3 patients (20%) 1. There was no statistically significant difference between the two groups for the preoperative and postoperative armretina time (p=0.65 and p=0.85) Small sample size No patient adverse events were reported Macular Translocation Surgery for AMD 12

13 (Author, (average, 74.1 years) 2. There was no statistically significant difference between the two groups for the preoperative and postoperative arteriovenous passage time (p=0.54 and p=0.93). Mruthyunjaya et al. (2005) USA 12 A prospective, interventional, consecutive, noncomparati ve case series 64 patients with bilateral neovascular AMD treated with MT360 in the eye with more recent vision loss Patients were divided into 3 groups based on lesion size: Group 1 (n=10): small ( 4 MPS DAs) Group 2 (n=31): medium (>4-9 MPS DAs) Group 3 (n=23): large (>9 MPS DAs) MT 360 o and silicone oil tamponade No comparator was included 1. Distance visual acuity (letters) 2. Near VA (logmar) 3. Reading Speed (wpm) 1. At 1 year after MT360, there was no significant difference between median improvements in distance VA among the 3 lesion size groups (p=0.94) 2. Median near VA improved in all 3 lesion composition groups, with equivalent and significant improvement in patients with predominately classic and predominately occult CNV lesions. There was no significant difference between the median improvements among the 3 lesion Macular Translocation Surgery for AMD 13

14 (Author, composition groups (p=0.99). 3. There was no difference in median improvement in recent speed at 1 year among the 3 groups (p=0.79). Adverse events: Cahill et al. A (2005) USA 13 prospective, interventional, consecutive, noncomparati ve case series 50 patients (F=34 and M=16) with AMD Mean age of 76.9 years (SD=5.7) Macular translocation with 360 o peripheral retinectomy 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) and the Medical Outcomes 12-item short form (SF- 12) health survey were A complete list of complications for the overall group of patients in the Duke MtS360 study has previously been reported. 9. Complications were spread across at subgroups with the exception that retinal detachment with proliferative vitreoretinopathy and cystoid macular edema were not reported in the smallsized lesion subgroup Postoperative mean NEI VFQ-25 QoL scores were higher than the preoperative mean scores, and this difference was Outcomes were selfreported No patient adverse events were reported Caution may b e needed Macular Translocation Surgery for AMD 14

15 (Author, used to assess visionrelated QoL and general health, respectively significant for important vision specific subscales 2.Patients with improved visual function had greater mean changes in NEI VFQ-25 QoL subscale scores than those with no improvement in interpreting the aggregate score of the 3 important qualities of vision NEI VFQ-25 subscales and the 4 important vision-specific NEI VFQ-25 subscales, as the NEI VFQ-25 was only tested on the composite of all 11 subscales. 3. Patients with the outlines higher levels of visual function had greater mean NEI VFQ-25 QoL scores than those who had worse visual function 4. Preoperative and postoperative mean SF-12 QoL scores were similar AMD=Age-related macular degeneration; CNV=choroidal neovascularization; ETDRS= Early Treatment Diabetic Retinopathy ; logmar=logarithm of the minimum angle of resolution; MPS DAs=Macular Photocoagulation disk areas; MT360=Macular translocation with 360 o retinotomy Macular Translocation Surgery for AMD 15

16 Appendix B: Descriptions of Selected Tests for Clinical Outcomes Measured Visual Outcome Test Test Description Distance VA SST protocol 7,9,12 Submacular Surgery Trials investigated outcomes of surgery being practiced by retinal surgeons to remove CNV that are linked with AMD and other causes 17 Bailey-Lovey charts 7,9,12 Test for determining VA via letter recognition. Bailey-Lovie charts incorporate the European design of logmar (i.e. letter sizes are rectangular). 18 As well, all letters in this chart have the same contrast but their size varies. 19 Near VA Lighthouse near card 7 Text size are reported in meters of text (e.g. 10 meters or 1.0 meters) measured on the card. 7 Best corrected VA Early Treatment Diabetic Retinopathy chart (ETDRS) 6,8 ETDRS was a multicenter, randomized clinical trial designed to evaute argon laser photocoagulation and aspirin treatment in the management of patients with nonproliferative and early proliferative diabetic retinopathy. 20 One line equals five letters using the standard refraction protocol, standard retro-illuminated ETDRS charts. 6 Reading speed Sloan reading card 7 Test measures reading speed at the patient s preferred focal distance, still using the add correction. 7 Contrast sensitivity LEA near-contrast 7 Contrast becomes lower with each number on the chart. The grading for contrast sensitivity was by number count, ranging from zero numbers read correctly to a top score of 30 numbers. 7 Colour vision Precision Vision (PV)16 7 Colours are categorized into the following grades: grade 5, all 16 discs in correct order; grade 4, three or fewer discs Macular Translocation Surgery for AMD 16

17 incorrectly placed by one place; grade 3, one colour family, but fewer than five discs, incorrect; grade 2, two colour families incorrect with fewer than six discs incorrect; grade 1, more then two families incorrect but at least three discs correct; grade 0, all plates incorrect. 7 Macular Translocation Surgery for AMD 17

18 References: 1. Canadian Ophthalmological Society evidence-based clinical practice guidelines for the periodic eye examination in adults in Canada. Can J Ophthalmol 2007;42(1): Colagiuri S, Miller JJ, Petocz P. Double-blind crossover comparison of human and porcine insulins in patients reporting lack of hypoglycaemia awareness. Lancet 1992;339(8807): Macular translocation for age-related macular degeneration. [International procedure guideline no 48]. London: National Institute for Clinical Excellence; Available: (accessed 2007 Oct 25). 4. Brown MM, Brown GC, Stein JD, Roth Z, Campanella J, Beauchamp GR. Age-related macular degeneration: economic burden and value-based medicine analysis. Can J Ophthalmol 2005;40(3): Falkner CI, Leitich H, Frommlet F, Bauer P, Binder S. The end of submacular surgery for age-related macular degeneration? A meta-analysis. Graefes Arch Clin Exp Ophthalmol 2007;245(4): Lüke M, Ziemssen F, Bartz-Schmidt KU, Gelisken F. Quality of life in a prospective, randomised pilot-trial of photodynamic therapy versus full macular translocation in treatment of neovascular age-related macular degeneration - a report of 1 year results. Graefes Arch Clin Exp Ophthalmol; Toth CA, Lapolice DJ, Banks AD, Stinnett SS. Improvement in near visual function after macular translocation surgery with 360-degree peripheral retinectomy. Graefes Arch Clin Exp Ophthalmol 2004;242(7): Lüke C, Alteheld N, Aisenbrey S, Lüke M, Bartz-Schmidt KU, Walter P, et al. Electrooculographic findings after 360 degrees retinotomy and macular translocation for subfoveal choroidal neovascularisation in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2003;241(9): Mruthyunjaya P, Stinnett SS, Toth CA. Change in visual function after macular translocation with 360º retinectomy for neovascular age-related macular degeneration. Ophthalmology 2004;111(9): Lai JC, Lapolice DJ, Stinnett SS, Meyer CH, Arieu LM, Keller MA, et al. Visual outcomes following macular translocation with 360-degree peripheral retinectomy. Arch Ophthalmol 2002;120(10): Çekiç O, KesercI B, Ohji M, Sawa M, Ikuno Y, Gomi F, et al. Macular translocation surgery and retinal circulation times. Retina 2004;24(1): Mruthyunjaya P, Stinnett SS, Toth CA. Impact of fluorescein angiographic characteristics of macular lesions on outcomes after macular translocation 360 degree surgery in eyes with age-related macular degeneration. Retina 2005;25(5): Macular Translocation Surgery for AMD 18

19 13. Cahill MT, Stinnett SS, Banks AD, Freedman SF, Toth CA. Quality of life after macular translocation with 360º peripheral retinectomy for age-related macular degeneration. Ophthalmology 2005;112(1): Schneider R, Rademacher M, Wolf S. Lacunar infarcts and white matter attenuation. Ophthalmologic and microcirculatory aspects of the pathophysiology. Stroke 1993;24(12): Electrooculography [web page]. In: Wikipedia encyclopedia; Available: (accessed 2007 Oct 26). 16. Standards, recommendations and guidelines. Glasgow (UK): International Society for Clinical Electrophysiology of Vision; Available: (accessed 2007 Oct 25). 17. News and events: NEI statement. In: National Eye Institute. Bethesda (MD): National Eye Institute; Available: (accessed 2007 Oct 26). 18. ETDRS Acuity Testing [web page]. In: VectorVision. Greenville (OH): VectorVision; Available: (accessed 2007 Oct 26). 19. Eye exam for cataract [web page]. In: The eye digest. Chicago: University of Illinois of Eye & Ear Infirmatory; Available: (accessed 2007 Oct 26). 20. Early treatment diabetic retinopathy study (ETDRS) [web page]. In: National Eye Institute. Bethesda (MD): National Eye Institute; Available: (accessed 2007 Oct 26). Macular Translocation Surgery for AMD 19