(<5%¡Ý2 line loss)
English translation: iY is a mistake/typo. Should be (5%< or > or = 2 line loss)
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| 11:50 Jun 28, 2005 |
| English language (monolingual) [PRO] Medical - Medical: Instruments / IMPLANTABLE CONTACT LENS | |||||||
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|  Selected response from: Lingo Pros United States Local time: 15:05 | ||||||
Grading comment
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| SUMMARY OF ALL EXPLANATIONS PROVIDED | ||||
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| 3 | Which part exactly do you want explained? |
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| 3 | iY is a mistake/typo. Should be (5%< or > or = 2 line loss) |
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Answers
2 hrs confidence: 
| (<5%¡Ý2 line loss) Which part exactly do you want explained? Explanation: As I read it, the FDA set certain guidelines, requiring that less then 5% of operated eyes should have a vision loss of about 2 lines. The researchers' data were way below the upper threshold. Hooray to them! Here's an extract from the FDA recommendations (from it, you can see why there is an approximation sign before "2 lines"): ====== The chart luminance should be 3 cd/m2 or less and the ambient illumination should be lower than the chart luminance. In order to limit pupil constriction and maintain uniform glare conditions across the test chart, the glare source should be an array of two or more small spots symmetrically positioned around the chart. The level of glare should be the minimum necessary to significantly reduce the contrast sensitivity of young adult subjects with normal corneas and normal vision, but the illumination should not be so great as to completely wash out the target in these young, normal subjects. The reduction in contrast sensitivity due to glare in normal subjects should be a mean loss of between 0.15 and 0.45 log units at 6 cycles/degree (for grating charts) or an approximate two line loss on a letter acuity chart of approximately 10% contrast. A small pilot study of normal subjects may be necessary to determine an appropriate glare level. ========= |
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14 hrs confidence:
| (<5%¡Ý2 line loss) iY is a mistake/typo. Should be (5%< or > or = 2 line loss) Explanation: Six months after ICL implantaiton we have: 2 line loss in 2.8% of eyes + a more than 2 line loss in 0.4% of eyes Both percentages added together in this ICL method of implantation is equal to 3.2% which is well below the FDA (US Food and Drug Administration)targets for Refractive Implants or Refractive Lasers which are 5% of the eyes experiencing line losses. So this method of implantation has a better result. -------------------------------------------------- Note added at 14 hrs 26 mins (2005-06-29 02:16:09 GMT) -------------------------------------------------- Explanations about ICL Implantations: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3991t1.ht... -------------------------------------------------- Note added at 14 hrs 41 mins (2005-06-29 02:31:53 GMT) -------------------------------------------------- Corrections: 1- \"Both percentages added together in this method of ICL implantation...\" 2- \"...Refractive Lasers in which about 5% of the eyes experience line loss\" |
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