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Session Title: Intracorneal inlays for correction of presbyopia
Session Date/Time: Tuesday 08/10/2013 | 08:00-10:30
Paper Time: 09:54
Venue: Main Lecture Hall (Ground Floor)
First Author: : J.Whitman USA
Co Author(s): :
To assess the evolution and stability of near visual acuity, visual symptoms and patient satisfaction after monocular implantation of the Raindrop Near Vision Inlay (ReVision Optics, Inc., Lake Forest, CA) in presbyopes.
Key-Whitman Eye Center. Dallas, TX, USA
As part of a multi-center, prospective FDA study, 46 subjects from one clinical site were implanted with the Raindrop Near Vision Inlay. Prior to implantation the subjects were given a LogMAR reading card, asked to note the line that could be read with ease, and then date and initial their selection. Visual acuity for distance (4 M), intermediate (80 cm) and near (40 cm) was tested using standardized ETDRS charts at 1 week, 1, 3 and 6 months. Visual symptoms, visual clarity, and patient satisfaction were also evaluated via patient response including the validated NEI Quality of Life questionnaire.
Pre-operatively subjects had an UCNVA (logMAR) range of 0.4 to 0.9 (mean 0.6), and a UCIVA range of 0 to 0.7 (mean 0.3). Near visual acuity at 1 week improved 4 lines in the treated eye (mean 0.1), and that improvement remained stable over time (mean UCNVA 0.0 at 6 months). UCIVA showed a similar pattern, with an improvement of approximately 2 lines vs preoperative values. Binocularly, all patients but one achieved 0.1 or better at all distances. Visual symptoms were minimal (one subject complained of fluctuation at 1 month, one subject had halos at 3 months). At the 6-month visit there were no patients complaining about visual symptoms. Patient satisfaction was 93% at 6 months.
All subjects reported their ability to perform unaided near and intermediate tasks by 1 week after implantation had exceeded expectations. Distance functional vision was little affected, and patient satisfaction with their near functionality achieved from the earliest postoperative period with the Raindrop Near Vision Inlay has proved sustainable for these patients throughout sequential follow-up visits.
... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented
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