Surgical Correction of Presbyopia

Lenticular, Corneal, and Scleral Approaches

Michael Greenwood, MD; Shamik Bafna, MD; Vance Thompson, MD

Disclosures

Int Ophthalmol Clin. 2016;56(3):149-166. 

In This Article

Space-occupying Inlay to Create a Hyperprolate Cornea

The Raindrop corneal inlay (Figs. 2A, B), previously known as the Presbylens and then the Vue+ (ReVision Optics, Lake Forest, CA), was developed in 2007 for the treatment of plano presbyopia. The Raindrop is a permeable hydrogel lenticule, which allows for fluid and nutrient flow. The lenticule is 2.0 mm in width and is approximately 10 mm thick at the periphery and ranges from 24 to 40 mm thick at the center. It has no refractive power and has a water content and refractive index similar to that of the human cornea. The inlay is inserted under either a LASIK flap or into a corneal pocket at a depth of approximately 120 to 130 μm in the nondominant eye. The lenticule induces a differential surface curvature change, which results in a multifocal cornea, improving near and intermediate vision. Distance acuity is minimally affected as light rays paracentral to the 2 mm inlay remain primarily focused on the retina, particularly with a dilated pupil. Pupil constriction creates a pseudoaccommodative state, utilizing the steepened central cornea. Complications related to the Raindrop are similar to that of other inlays and include repositioning or removing the device.

Figure 2.

Raindrop inlay under standard lighting (A) and retroillumination (B).

The Raindrop has received CE mark in the European Union and is currently in US FDA Phase III clinical trials. Sharma and colleagues [Sharma D, Porter T, Holliday K, Le A, Tran-Hata P, Gomez S, Barragan E. Sustainability and biocompatibility of the presbylens corneal inlay for the correction of presbyopia, 2010; ARVO Abstract 813, unpublished] reported data on 8 near-plano presbyopic eyes with the 1.5 mm inlay placed under a microkeratome-created lamellar flap. All eyes retained 20/32 or better UNVA at 2 years postoperatively. The mean gain in UNVA was 3.6 lines with a binocular mesopic UDVA of 20/25 or better for all patients. All subjects reported that they were satisfied with the surgery and were able to perform typical near tasks without glasses. Porter and colleagues described vision results from a series of hyperopic eyes with the 2.0 mm design implanted. There was an average UNVA improvement of >5 lines by 1 month after surgery, with 78% of the implanted eyes achieving 20/25 or better. Uncorrected intermediate visual acuity improved by an average of 4 lines, and mean distance UDVA was 20/25.[23] In another study, 25 hyperopic presbyopes underwent implantation of the 2.0 mm corneal inlay combined with LASIK. After 1 month, >80% of these eyes achieved J1 or better UNVA. There was also UIVA improvement, by an average of 5 lines, to 20/25, and improvement in UDVA averaged 2 lines, with 1 subject losing 1 line.[24] Barragan Garza and colleagues reported 1-year results of 20 emmetropic and presbyopic patients. Twelve months after implantation, the mean monocular and binocular UNVA were 0.1 logMAR (~20/25) or better and the mean monocular UDVA was 0.2 logMAR (~20/32) or better. A minimal mean CDVA and CNVA loss of 0.02 logMAR occurred, and no patient lost 2 or more lines. One patient required inlay removal because of poor UDVA (0.4 logMAR; ~20/50). One month after removal, the UDVA returned to 0.0 logMAR (~20/20). At 1 year, 16 of the remaining 19 patients seldom or never wore glasses, and all 19 were satisfied or very satisfied with their overall vision.[25]

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