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Adam Roy, Alan Lang, Tonya Porter, Keith Holliday, Guru Sharma, Arturo Chayet, Edna Favela, Enrique Barragan, Sandra Gomez; Bilateral Implantation of Hydrogel Corneal Inlays in Hyperopic Presbyopes. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3129.
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To provide hyperopic, presbyopic patients with improved near, intermediate, and distance vision using bilateral hydrogel corneal inlays.
Twenty-two hyperopic (mean pre-op spherical equivalent (MRSE): 0.99 D (non-dominant eye) and 0.97 D (dominant eye) [+0.25 to +1.75 D]), presbyopic (mean pre-op reading add requirement: 1.89 D (both eyes) [+1.50 to +2.25 D]) subjects were implanted with 2.0 mm diameter hydrogel corneal inlays (ReVision Optics, Inc.)* under a femtosecond corneal flap, in the non-dominant eye, followed for 3 to 6 months, and then implanted with a like inlay in the dominant eye. The Optec® 6500 Vision Tester was used to record visual acuities. Ability to perform everyday tasks (five tasks for each of three distance ranges) without additional visual aid was ascertained using a questionnaire. The study was performed in conformance with an IRB-approved protocol.
The non-dominant (NONDOM) and dominant (DOM) eyes in the same subject responded similarly to the corneal inlay. In both eyes measured separately, uncorrected visual acuity (UCVA) had improved significantly at 3 months, by an average of 5 lines of near, 3 lines of intermediate, and 1 line of distance vision. Near and intermediate vision improved in 100% of the eyes. 86% of implanted NONDOM eyes and 95% of DOM eyes achieved 20/25 or better near UCVA compared to 0% preoperatively. 77% of implanted NONDOM eyes and 86% of DOM eyes achieved 20/25 or better intermediate UCVA compared to 0% preoperatively. Both groups had an average improvement of 1 line distance UCVA though two subjects lost one line of distance vision in the NONDOM eye. The average distance UCVA for each eye was 20/21. At 3 months after the second inlay, binocularly, 95% of subjects achieved 20/25 or better near UCVA and intermediate UCVA, and 100% of subjects achieved 20/20 or better distance UCVA. There was a significant improvement in task performance and patient satisfaction with bilateral inlays in comparison to pre-op. At 3 months after the 2nd implantation, 95% of subjects were satisfied or very satisfied with their overall vision.
Bilateral implantation of the ReVision Optics corneal inlay is potentially an effective tool to improve near, intermediate, and distance vision in hyperopic presbyopes up to +1.75 D MRSE. *CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
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