Impact of sham-controlled vertebroplasty trials on referral patterns at two academic medical centers.

Debate persists regarding the merit of vertebroplasty following publication of blinded vertebroplasty trials in 2009, one of which was the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST). This study was performed to determine whether referring physicians at two academic medical centers were aware of the trial results and to assess if this awareness prompted a change in their treatment of osteoporotic fractures. E-mail surveys were distributed to physicians within the Mayo Clinic and Baylor Health Care System (BHCS). Of 1390 surveys sent, 194 (14%) were returned. Results showed that 92 of 158 respondents (58%) reported familiarity with INVEST; 66 of 92 (72%) agreed that INVEST changed their understanding of vertebroplasty efficacy; and 64 of 92 (70%) agreed that INVEST diminished their enthusiasm to refer patients for vertebroplasty. However, 105 of 159 respondents (66%) felt vertebroplasty was an effective procedure in appropriate patients. Mayo physicians were more likely than BHCS physicians to be aware of INVEST (73% vs 67%, P < .0001), respond that INVEST changed their understanding of the appropriate treatment for osteoporotic compression fractures (79% vs 57%, P = 0.026), view vertebroplasty less favorably (45% vs 21%, P = 0.005), and treat osteoporotic compression fractures with medical therapy/pain management alone (73% vs 48%, P = 0.003). INVEST changed referring physicians' understanding of the role of vertebroplasty and diminished their willingness to refer osteoporotic compression fracture patients; the impact varied by location.

Prospective evaluation of PermaVision intracorneal implants using in vivo confocal microscopy.

PURPOSE: To report effects of the PermaVision intracorneal lens at the cellular level using in vivo confocal microscopy. METHODS: Four eyes implanted with intracorneal lenses beneath an IntraLase flap for correction of hyperopia were evaluated preoperatively and 1 to 6 months postoperatively. RESULTS: Intracorneal lenses were tolerated in three eyes with little or no haze observed clinically and good visual results. Minimal keratocyte activation was detected by confocal microscopy, and cell density was decreased posterior to the implants. Epithelial thinning was observed 1 month after implantation. Thickness stabilized by 6 months but remained thinner than baseline (33 +/- 2 microm vs 48 +/- 8 microm, P < .01). The fourth eye had a complicated course with early flap displacement followed by diffuse lamellar keratitis. Confocal microscopy revealed activated keratocytes throughout the anterior stroma. The implant was removed, and recovery was promising. CONCLUSIONS: Implantation of intracorneal lenses can induce side effects of epithelial thinning, keratocyte loss, and keratocyte activation.

Confocal assessment of the corneal response to intracorneal lens insertion and laser in situ keratomileusis with flap creation using IntraLase.

PURPOSE: To assess the response of the cornea to hydrogel intracorneal lens (ICL) insertion or laser in situ keratomileusis (LASIK) with IntraLase (IntraLase Corp.) at the cellular level. SETTING: Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, USA. METHODS: Twenty patients (29 eyes) were evaluated by in vivo confocal microscopy 1 to 6 months postoperatively: 20 eyes had LASIK with flap creation by IntraLase, and 9 eyes had ICL insertion (8 following IntraLase). RESULTS: For LASIK with IntraLase, keratocyte activation and/or interface haze was detected in 8 of 20 eyes. The remaining eyes had interface particles but no cell activation. Keratocyte activation was generally limited to a few cell layers adjacent to the interface. However, 2 patients exhibited multiple layers of activation and increased extracellular matrix (ECM) reflectivity (haze) surrounding the interface by confocal microscopy. Both patients also had clinical haze and photophobia. For ICLs, following insertion, 5 of 9 eyes had activated keratocytes adjacent to the implant surfaces. The largest amount of cell activation and ECM haze detected by confocal microscopy was in 2 patients with significant clinical haze. Structures with an epithelioid morphology were detected on some implant surfaces. Epithelial thickness was 33.3 microm +/- 2.3 (SD) in the ICL eyes and 49.2 +/- 6.5 microm in the LASIK with IntraLase eyes. CONCLUSIONS: Both LASIK with IntraLase and ICL insertion following IntraLase induced keratocyte activation, which may underlie clinical observations of haze in some patients. Intracorneal lens implant also induced thinning of the overlying corneal epithelium.