RESUMEN
The purpose of this study was to report visual prognosis after explantation of a small-aperture corneal inlay used for the treatment of presbyopia. This is a retrospective case series conducted at a single site in Draper, Utah, USA (Hoopes Vision). Medical records of 176 patients who had received a small-aperture corneal inlay (KAMRA™, AcuFocus Inc., Irvine, CA, USA) were reviewed. Patients who had undergone explantation of the device were identified. Uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), and manifest refraction spherical equivalent (MRSE) were measured pre-implantation, post-implantation, pre-explantation, and post-explantation of the inlay. Ten eyes from ten patients were included in this study. The explantation rate was 5.7% over 31 months, with blurry vision as the most common complaint. After explantation, six patients achieved pre-implantation UDVA, and six achieved pre-implantation UNVA. Eight of nine patients who underwent final manifest refraction achieved pre-operative CDVA. All patients had residual donut-shaped corneal haze in the stroma at the previous position of the inlay. All patients experienced improvement in haze with 20% experiencing complete resolution. The degree of stromal haze was not related to the duration of implantation. Of the subset of patients who underwent explantation of their small-aperture corneal inlay, there was persistent loss of CDVA in 10%. The majority of patients experienced some level of residual stromal haze, which may contribute to deficits in UNVA and CDVA in few patients. A hyperopic shift induced by the corneal inlay may contribute to the blurry vision these patients experienced; there was a reduction of this shift post-explantation. While this device is removable, patients should expect some post-explantation changes such as residual haze with a small subset experiencing persistent deficits in CDVA.
RESUMEN
The purpose of this case series is to report visual outcomes in patients who underwent explantation of the Raindrop® hydrogel corneal inlay. Retrospective chart review comprising four cases of explantation of the Raindrop® corneal shape-changing hydrogel inlay: pre-implantation, pre-explantation, and post-explantation values for uncorrected distance visual acuity, uncorrected near visual acuity, and corrected distance visual acuity (CDVA) were measured; keratometric and tomographic data were collected using the Pentacam system (Oculus, Inc). Three eyes were explanted for progressive haze after implantation that persisted even after removal; one eye was explanted due to poor visual acuity with no haze formation. All patients experienced decreased unaided and corrected distance visual acuity. Persistent increase in corneal thickness and mean keratometry was noted post-explantation. All four patients regained their original near visual acuities, but one patient had persistent one-line loss in CDVA. There are long lasting tomographic corneal changes following Raindrop inlay explantation. In addition, persistent increased corneal thickness could be related to semi-permanent changes in corneal structure and may account for residual haze experienced by patients. After explantation, patients may not return to baseline CDVA.