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Volume 11, Number 30
Monday, July 25, 2011
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JULY IS EYE INJURY PREVENTION MONTH  





In this issue: (click heading to view article)
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######### Prediction of Subjective and Functional Deterioration in Recurrences of Neovascular AMD

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######### Impact of Disc Size on ONH vs. RNFL Assessment for Glaucoma Diagnosis
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######### Role of Fellow Eye in Progression of Age-Related GA
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######### Evaluation of Visual Quality Following Monovision Correction by LASIK in Presbyopic Patients
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http://ecatalog.alcon.com/PI/Nevanac_us_en.pdf


Prediction of Subjective and Functional Deterioration in Recurrences of Neovascular AMD

German investigators performed a prospective interventional case series in which they applied different tests to assess the sensitivity of patient self-control; Amsler grid and visual acuity (VA) assessment, as well as fundus examinations to reveal recurrent choroidal neovascularization (CNV) activity in age-related macular degeneration as detected by spectral domain optical coherence tomography (SD-OCT) in monthly controls.

They examined a series of patients with exudative age-related macular degeneration (AMD) that received ranibizumab injections until complete resolution of fluid in SD-OCT. They conducted an analysis of changes in subjective perception, Amsler grid, early treatment diabetic retinopathy study (ETDRS) VA, Radner reading VA and fundus examination in the case of OCT-confirmed CNV recurrences.

Out of 40 morphological recurrences determined by SD-OCT, six (15%) were noticed by subjective patient perception. According to the investigators, Amsler grid testing revealed deterioration in 12 cases (30%); 11 recurrences (28%) were accompanied by loss of ≥5 letters in ETDRS VA and/or ≥1 line in Radner VA; fundus examination showed signs of novel CNV activity in 10 out of 40 recurrences (25%). They reported that the combined sensitivity of all diagnostic methods compared to SD-OCT for recurrence detection was 67.5% (27 out of 40 recurrences).

Subjective patient perception, Amsler grid, VA and fundus examination lead to pronounced underestimations of CNV recurrences, the investigators determined. They concluded that morphologic recurrences can be detected prior to functional deterioration and as any delay of treatment can result in irreversible vision loss, attempts should be made to provide monthly OCT controls to detect recurrences as early as possible.

SOURCE: Hoerster R, Muether PS, Hermann MM, et al. Subjective and functional deterioration in recurrences of neovascular AMD are often preceded by morphologic changes in optic coherence tomography. Br J Ophthalmol. 2011; July 18 [Epub ahead of print].







Impact of Disc Size on ONH vs. RNFL Assessment for Glaucoma Diagnosis

An Italian observational, cross-sectional evaluation of diagnostic tests explored and compared the influence of optic size on the diagnostic accuracy of retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) quantitative assessment.

Included were 120 eyes of 50 normal subjects and 70 glaucomatous patients classified by the presence of a repeatable visual field defect for the analysis. The RNFL thickness was measured by scanning laser polarimetry with variable corneal compensator (GDx-VCC, Carl-Zeiss Meditec) and spectral-domain optical coherence tomography (Cirrus HD-OCT). Imaging was obtained by means of confocal scanning laser ophthalmoscopy (HRT3; Heidelberg Engineering, GmbH). Main outcome measures were sensitivity and specificity for normative classifications, sensitivity at fixed specificity and area under the receiving operating characteristics curve (AUC) for continuous parameters. A logistic marginal regression model and coefficients of variation (CoV) have been used to test and quantify the influence of optic disc size on the diagnostic accuracy of the 3 technologies under investigation.

Among continuous parameters average RNFL thickness for Cirrus HD-OCT, nerve fiber indicator for GDx-VCC and cup shape measure for the HRT3 showed the best diagnostic accuracy with an AUC of 0.97, 0.94 and 0.94, respectively. Among normative classifications, the highest sensitivity and specificity were found for OCT average RNFL thickness (75.8% and 94.7%), for GDx superior thickness (77.1% and 97.5%), for HRT3 Moorfields regression analysis result (89.4% and 73.7%) and for HRT3 GPS global (92.3% and 76.5%). It was reported that the diagnostic performance of HRT3 parameters seemed to be significantly influenced by optic disc size, although the same was not true for Cirrus HD-OCT and GDx VCC. The most steady performers for each imaging device across disc groups were Cirrus HD-OCT average thickness (CoV, 1.6%), GDx-VCC inferior thickness (CoV, 2.5%) and HRT3 GPS temporal and nasal (CoV, 21.4%).

To conclude, the diagnostic accuracy of quantitative RNFL assessment as performed by Cirrus HD-OCT and GDx-VCC is high and virtually unaffected or only minimally affected by the size of the optic disc and may provide more consistent diagnostic outcomes across small and large discs than ONH assessment as performed by HRT3.


SOURCE: Oddone F, Centofanti M, Tanga L, et al. Influence of disc size on optic nerve head versus retinal nerve fiber layer assessment for diagnosing glaucoma. Ophthalmol. 2011;118(7):1340–7.

http://www.revophth.com/ResFellowEdu2011







Role of Fellow Eye in Progression of Age-Related GA

To evaluate the role of the fellow eye status for progression of geographic atrophy (GA) in patients with age-related macular degeneration (AMD), the authors of this study classified 300 eyes with GA of 193 patients from the prospective, longitudinal natural history FAM-Study into 3 groups according to the AMD manifestation of the fellow eye at baseline examination: (1) bilateral GA, (2) early/intermediate AMD, and (3) exudative AMD. They quantified the GA areas based on fundus autofluorescence images using a semi-automated image processing method and estimated progression rates (PR) using 2-level linear mixed effects-models.

Crude GA-PR in the bilateral GA group (mean 1.64mm²/year, 95% CI [1.478;1.803]) was significantly higher compared to the fellow eye early/intermediate group (0.74mm²/year [0.146;1.342]), the authors found. Although there was significant difference in baseline GA-size (p=0.0013, t-test), and there was a significant increase of GA-PR by 0.11mm²/year (95% CI [0.05; 0.17]) per one disc area (1DA=2.54mm²), an additional mean change of –0.79 (95% CI [–1.43, –0.15]) was given to the PR beside the effect of baseline GA size. However, according to the authors, this difference was only significant when GA size was ≥1DA at baseline with a GA-PR of 1.70mm²/year, 95% CI [1.54; 1.85] in the bilateral and 0.95mm²/year [0.37; 1.54] in the early/intermediate group. They determined that there was no significant difference in PR comparing with the fellow-eye exudative group.

The results indicate that the AMD manifestation of the fellow eye at baseline serves as an indicator for disease progression in eyes with GA ≥ 1DA. Predictive characteristics may not only contribute to the understanding of pathophysiological mechanisms, but are also useful for the design of future interventional trials in GA patients.

SOURCE: Fleckenstein M, Schmitz-Valckenberg S, Adrion C, et al; for the FAM Study Group. Progression of age-related geographic atrophy: role of the fellow eye. Invest Ophthalmol Vis Sci. 2011; July 14 [Epub ahead of print].


Evaluation of Visual Quality Following Monovision Correction by LASIK in Presbyopic Patients

In the following cohort study, researchers in Spain sought to evaluate visual quality after laser in situ keratomileusis (LASIK) performed to achieve monovision in presbyopic patients.

They performed LASIK with the Allegretto Wave Eye-Q 400 Hz laser and corrected the dominant eye for far vision and the nondominant eye for near vision by targeting –1.25D of myopia. The researchers programmed the F-CAT algorithm targeting a postsurgical corneal asphericity of –0.80 in the dominant eye and –1.00 in the nondominant eye and analyzed visual acuity, contrast sensitivity function, ocular aberrations, stereoacuity, the scattering index and the visual discrimination capacity preoperatively and 3 months postoperatively.

The study researchers enrolled 25 patients (50 eyes) with a mean age of 49.3 years ± 4.5 (SD). They found that postoperatively, more than 90% of patients had a binocular uncorrected distance and near visual acuity of 0.0 logMAR or better, although the contrast sensitivity function diminished, especially in the nondominant eye and with binocular vision. They noted that stereoacuity was significantly worse in all patients (p<.001) and that the visual discrimination capacity declined in nondominant eyes and under binocular conditions (p<.005); no significant changes occurred in dominant eyes (p=.614). Moreover, in all eyes, the mean objective scatter index value increased postoperatively, but not significantly (p>.05).

The researchers found that monovision correction by LASIK improved functional near vision in presbyopic patients. They found that although visual acuity was good for far vision, contrast sensitivity and stereoacuity diminished significantly.

SOURCE: Alarcón A, Anera RG, Villa C, et al. Visual quality after monovision correction by laser in situ keratomileusis in presbyopic patients. J Cataract Refract Surg. 2011;July 13 [Epub ahead of print].




  • APPLICATION FOR AN EXTENSION OF THE INDICATION FOR MACUGEN WITHDRAWN BY PFIZER LIMITED. According to a news release by The European Medicines Agency, Pfizer Limited has decided to withdraw its application for an extension of the therapeutic indication for the centrally authorized medicine Macugen (pegaptanib sodium), 0.3 mg solution for injection. Pfizer Limited submitted the application to extend the marketing authorization for Macugen on June 14, 2010 to include the treatment of visual impairment due to diabetic macular edema in the indication. The company stated in an official letter that its decision to withdraw the application was based on the European Medicines Agency's Committee for Medicinal Products for Human Use's (CHMP's) view that the data provided thus far does not allow the Committee to conclude on a positive benefit-risk balance in the application for indication. Additional information about Macugen and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer documents, which, together with the withdrawal letter from Pfizer Limited, will be published on the Agency's website following the July CHMP meeting.
  • RANIBIZUMAB NOT RECOMMENDED BY NICE FOR DME TREATMENT. In final draft guidance issued, The National Institute for Health and Clinical Excellence (NICE) has not recommended ranibizuamb (Lucentis) for the treatment of diabetic macular edema (DME). The independent Appraisal Committee considered that the manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) for ranibizumab monotherapy compared with the current standard treatment for people with DME: laser photocoagulation. It concluded that a model that relied on a combined set of plausible assumptions would be certain to produce an ICER that substantially exceeded the range that NICE considers represents an effective use of National Health Service (NHS) resources. Therefore, ranibizumab could not be recommended as a treatment for people with DMO. Final guidance is expected to be published in August 2011, but until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology, it replaces local recommendations across the country. Read more here.
  • VISIAN ICL CANDIDATES HAVE CHANCE TO WIN FREE LENSES AND RELATED SURGERY. STAAR Surgical Company recently launched the “Want My Visian” contest on Facebook to provide free Visian ICLs (Implantable Collamer Lenses) and related surgery for up to 12 grand prize winners. To compete, they will be required to upload a 30-second video explaining why they want the clear vision provided by the Visian ICL. Videos submitted as part of the contest will be made available on Facebook for public viewing and each video that earns at least 100 votes by 12:01 a.m. on September 24th will be entered into a random drawing for the grand prize. To be eligible, participants must have been informed by a certified Visian ICL ophthalmologist that they are a candidate for the lens. July 31st is the official entry deadline, and on or before September 30th, STAAR Surgical will randomly select a number of grand prize winners equal to 50% of the total number of qualified participants. The application form and rules can be requested by e-mailing [email protected] (include subject line: “contest”). Click here for more information.