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Daniel R. Neal, Thomas D. Raymond, Amelia Saliba, Stan Bentow, Ying Wang, Steve Farrer, James Copland, Wei Xiong, David Baer, Ron Rammage; Lasik Treatment Outcomes With A High Resolution Aberrometer/Corneal Topographer. Invest. Ophthalmol. Vis. Sci. 2012;53(14):1485.
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Evaluate the performance of a new combined aberrometer instrument and treatment planning software used for measurement of human ocular aberrations and treatment of myopia (near sightedness) by LASIK surgery. The iDesign instrument measures ocular aberrations, corneal topography, keratometry, refraction and pupillometry. The Customvue treatment planning software generates the treatment plan which is delivered by the field proven STAR S4IR laser, an ArF (193 nm) surgical excimer laser with iris registration.
A treatment study was conducted at four sites in Canada, with review by an independent review board and Health Canada, to evaluate the performance and acceptability of the measurement/treatment process. 101 eyes of 52 subjects were enrolled in the study (1/2 male and 1/2 female). Aberrometer measurements were acquired on each subject, and this data was used to create the Lasik treatment plan. No physician adjustments were allowed under this study. The surgery had a 1 month and 3 month follow up to evaluate UCVA and BCVA. In addition, the intended vs. achieved performance was evaluated at 3 months.
Uncorrected visual acuity (UCVA) of 20/40 or better was 96.7% at 1 month and 100% at 3 months. Furthermore, 94.1% of eyes were 20/20 or better and 76.5% were 20/16 or better at 3 months. Comparison of postoperative UCVA to preoperative best spectacle corrected visual acuity (BSCVA) was conducted to assist with the assessment of device performance and acceptability. 85.7% (78/91) and 90.6% (77/85) of eyes demonstrated no significant change (≤ 1 line) at the 1 and 3-month visit, respectively. At 3 months, 42.4% (36/85) of eyes did not see as well uncorrected as they did at preop with best correction. Within the myopic cohort as a whole, 80.2% (73/91) and 77.6% (66/85) of eyes were within 0.50 D of emmetropia at 1 and 3 months, respectively. Also, 98.9% (90/91) and 97.6% (83/85) of eyes were within 1.00 D of target at 1 and 3 months, respectively.
This trial was conducted to provide assurance that the product under study, the STAR S4 IR with the iDesign System, would produce results that are acceptable and perform as intended. To evaluate laser vision correction results, performance and acceptability was assessed through review of safety and effectiveness variables. Device performance was acceptable and exceeded effectiveness targets.
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