Orbital Implants Receiving Food and Drug Administration Premarket Notification.

Purpose: This perspective explores the Food and Drug Administration (FDA) 510(k) program, occasionally referred to as premarket notification, which facilitates faster marketing of Class II medical devices, such as orbital implants by demonstrating "substantial equivalence" to previously approved devices. This allows for FDA clearance, rather than FDA approval of orbital implants via comparison to currently marketed implants rather than clinically proven safety standards.

Methods: Utilizing the FDA's publicly available 510(k) Premarket Notification database, we conducted a thorough search of FDA-cleared orbital implants dating back to the inception of the 510(k) process in 1976.

A Contemporary Risk Analysis of Iatrogenic Transmission of Creutzfeldt-Jakob Disease (CJD) via Corneal Transplantation in the United States.

Background: Creutzfeldt-Jakob disease (CJD) is a rare, fatal, neurodegenerative prion disease potentially transmissible through corneal transplantation. While statistical analyses performed two decades ago estimated the overall prevalence of CJD in the corneal donor pool to be low, the recent significant increase in corneal transplants performed and deaths due to CJD in the U.S.

Risks Posed to Corneal Transplant Recipients by COVID-19-Affected Donors.

The recent emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its resultant human disease, COVID-19, will likely have a significant impact on the corneal tissue donor pool. Current recommendations from the United States and global eye bank associations call for the outright avoidance of tissues from donors recently infected with or exposed to COVID-19. This conservative recommendation is currently appropriate given the reported ocular sequelae, tear film viral detectability, and transmissibility of COVID-19.

Long-term changes in keratometry and refraction after small aperture corneal inlay implantation.

Purpose: To assess longitudinal refractive, keratometric, and topographic changes following KAMRA small-aperture inlay implantation.

Design And Setting: Prospective study at a single site refractive surgery center.

Methods: Fifty patients underwent KAMRA small-aperture corneal inlay implantation for the correction of presbyopia.

Mechanisms of Optical Regression Following Corneal Laser Refractive Surgery: Epithelial and Stromal Responses.

Laser vision correction is a safe and effective method of reducing spectacle dependence. Photorefractive Keratectomy (PRK), Laser In Situ Keratomileusis (LASIK), and Small-Incision Lenticule Extraction (SMILE) can accurately correct myopia, hyperopia, and astigmatism. Although these procedures are nearing optimization in terms of their ability to produce a desired refractive target, the long term cellular responses of the cornea to these procedures can cause patients to regress from the their ideal postoperative refraction.

Ectasia following small-incision lenticule extraction (SMILE): a review of the literature.

Purpose: Four cases of corneal ectasia after small-incision lenticule extraction (SMILE) have been reported. In this review, we provide an overview of the published literature on corneal ectasia after SMILE and risk factors associated with this complication.

Methods: Case reports were identified by a search of seven electronic databases for pertinent heading terms between 2011 and July 2017.

Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays.

Aim: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED) submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia.

Methods: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA), adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE), and achieved monocular uncorrected near visual acuity (UNVA) at 24mo.

Results: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo.

Corneal Hydrops Secondary to Intrastromal Corneal Ring Intrusion into the Anterior Chamber 7 Years after Implantation: A Case Report.

Introduction: This report describes the first known case of late-onset intrusion of an intrastromal ring segment into the anterior chamber due to posterior migration of a ring segment. To our knowledge, intrastromal ring segment penetration has only been shown to occur in the intraoperative or immediate postoperative period. We postulate that the perforation in this case is due to progressive thinning of the cornea, possibly in combination with habitual eye rubbing.

Case of Presumed Transient Light-Sensitivity Syndrome After Small-Incision Lenticule Extraction.

Purpose: To report the first presumed case of transient light-sensitivity syndrome (TLSS) after small-incision lenticule extraction (SMILE).

Methods: A 27-year-old male patient was treated for severe photophobic symptoms occurring 7 weeks after undergoing a bilateral SMILE procedure. His comprehensive ocular examination was unremarkable and his visual acuity was unaffected.

Neodymium:YAG laser posterior capsulotomy in eye with an intrastromal inlay.

We report intraoperative issues, patient outcomes, and lessons learned from inadvertently contacting a Kamra corneal inlay with a neodymium:YAG (Nd:YAG) laser during a routine capsulotomy procedure for posterior capsule opacification. We also present scanning electron microscopic and histopathologic images from a series of 4 inlays implanted in postmortem porcine eyes that were purposely contacted with an Nd:YAG laser. Our capsulotomy patient developed a clinically insignificant and transient corneal opacity accompanied by mild blanching on the inlay.

Cataract Surgery in Patients with a Previous History of KAMRA Inlay Implantation: A Case Series.

Introduction: The visual outcome of cataract surgery in patients with a previous history of KAMRA inlay implantation is an emerging issue for which limited research exists. The purpose of this study is to describe postoperative visual outcomes in this patient population.

Methods: This is a case series with retrospective chart review.

Stereoacuity after small aperture corneal inlay implantation.

Purpose: The aim of this study was to compare stereoacuity before and after KAMRA corneal inlay implantation for the correction of presbyopia.

Patients And Methods: This is a prospective study of 60 patients who underwent KAMRA inlay implantation. Patients were examined before and 6 months after surgery for stereoacuity, uncorrected distance visual acuity (UDVA), and uncorrected near visual acuity (UNVA).

Short-term visual result after simultaneous photorefractive keratectomy and small-aperture cornea inlay implantation.

Purpose: To report the short-term results of simultaneous photorefractive keratectomy (PRK) and small-aperture cornea inlay implantation (KAMRA) surgery in treating presbyopia.

Methods: Simultaneous PRK and KAMRA inlay surgery was performed on 21 patients from July 2015 to March 2016. Follow-up exams were conducted at 1, 3, and 6 months postoperatively.

Rainbow glare after laser-assisted in situ keratomileusis: a review of literature.

This article reviews the current literature pertaining to rainbow glare (RG), including incidence rate, clinical presentation, etiology, prognosis, and management. RG is a rare optical complication of femtosecond laser-assisted in situ keratomileusis that results in patients seeing an array of spectral bands surrounding point sources of light under mesopic and scotopic conditions. The mechanism is thought to be a consequence of the formation of a transmissive diffraction grating on the posterior surface of the corneal flap created by the FS laser.