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Adam J Roy, Keith Holliday, Tonya Porter, Maggie Young, Alan J Lang, Edna Favela, Arturo Chayet, Enrique Barragan, Sandra Gomez; The Effect of Pupil Size and Decentration from Pupil Center on Visual Outcomes after Corneal Inlay Surgery for Presbyopia. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1545.
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To investigate the effect of preoperative pupil size and accuracy of centration on the pupil center on the postoperative vision of patients implanted with a hydrogel corneal inlay (Raindrop® Near Vision Inlay*, ReVision Optics, Lake Forest, CA) designed to correct poor near and intermediate vision in presbyopes. *CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
249 presbyopic subjects were implanted with a hydrogel corneal inlay in the non-dominant eye beneath a femtosecond flap. The meniscus shape of the inlay is designed to change the curvature of the anterior cornea to progressively increase refractive power from the pupil center. Patients were a mix of emmetropes, myopes and hyperopes, some of whom underwent a concurrent LASIK treatment to correct distance vision. Mesopic and photopic pupil sizes were recorded preoperatively, and wavefront aberrometry determined inlay position postoperatively. Visual performance was evaluated via uncorrected visual acuity (UVA) as measured using an Optec 6500 vision analyzer and by the unaided ability to perform common tasks under good and dim lighting as indicated by questionnaire responses. Statistical analyses were conducted to determine the impact of pupil size and centration on these visual outcomes after inlay implantation.
1 year after surgery, 78% of all visual tasks could be ‘Easily’ performed in dim lighting without correction, compared to 43% preoperatively. Patients with larger preoperative mesopic pupils performed better, and this difference was most noticeable for intermediate (p = 2 x 10-7) and distance (p = 2 x 10-8) tasks. At 1 month postoperative, 88% of inlays were within 0.5 mm radius of the targeted pupil center, and 98% were within 1.0 mm radius. The 244 patients within this 1.0 mm radius region had mean monocular UNVA 0.08, UIVA 0.14, and UDVA 0.17 logMAR and this was not associated with the level of inlay decentration (UNVA p = 0.9, UIVA p = 0.9, UDVA p = 0.3).
Preoperative mesopic pupil size is a factor associated with the ability to perform visual tasks after surgery, in particular larger pupils improve intermediate and distance task ability. Inlay centration, within 1 mm of target, is not a factor associated with visual acuity or visual performance.
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