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Clinical outcomes after implantation of a hydrogel shape-changing corneal inlay for the treatment of presbyopia

Poster Details

First Author: D.Tran USA

Co Author(s):                        

Abstract Details

Purpose:

To report clinical outcomes of emmetropic presbyopes implanted with the Raindrop�Â�® Near Vision Inlay (ReVision Optics, Inc., Lake Forest, CA, USA) as part of the US FDA clinical trial

Setting:

Multi-centers US FDA clinical trial including multiple private practices throughout the United States

Methods:

The Raindrop Near Vision Inlay was implanted under a femtosecond LASIK flap in the non-dominant eye of emmetropic presbyopes (MRSE: -0.50 D to �.00 D) to correct for presbyopia as part of a multi-center, non-randomized, prospective FDA study. Monocular and binocular ETDRS visual acuities were collected at various viewing distances throughout the study. Results at 24M will be presented and compared to pre-operative as well as other post-operative visits. Refractive stability will also be reported

Results:

At 24M (n=344), subjects on average gained 5.0 lines of near vision, 2.5 lines of intermediate, and ~1.0 line lost for distance in the treated eye. Nearly all subjects (88%) achieved 20/25 or better monocular uncorrected near visual acuity. 20/32 or better visual acuity was achieved in 90% of subjects at intermediate and 84% of subjects at distance. Binocularly, more than 96% of subjects had a visual acuity of 20/32 or better at all viewing distances (near, intermediate and distance). MRSE remained stable with more than 88% of subjects with less than 0.50 D change 3M to 24M

Conclusions:

Raindrop Inlay improves near and intermediate vision in the treated eye while maintaining good binocular function at all viewing distances. Subjects gained five lines at near 24 months after inlay implantation making the Raindrop an effective method for treating presbyopia. Refraction stabilizes shortly after implantation and remains stable out to 24 months

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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