Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data.

BACKGROUND: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. METHODS: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. RESULTS: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. CONCLUSIONS: Further studies such as randomized controlled trials are needed to validate the findings.

Comparison of Verisyse and Veriflex Phakic Intraocular Lenses for Treatment of Moderate to High Myopia 36 Months after Surgery.

PURPOSE: To compare refractive stability, endothelial cell count (ECC), incidence of complications, and patients' satisfaction between a rigid Verisyse (group I, n = 198) and foldable Veriflex (group II, n = 212) phakic intraocular lenses (pIOL) over 36 months postop. MATERIALS AND METHODS: This was a retrospective study. Patients' satisfaction and incidence of photic phenomena were evaluated at one month and one year postop. Data were analyzed to determine difference between groups for astigmatism, mean spherical equivalent (MRSE), uncorrected (UDVA) and corrected (CDVA) monocular distance visual acuity, complication rate (acute and chronic), and ECC. Differences were considered statistically significant when p < 0.05. RESULTS: Group II cases had significantly higher UDVA, CDVA, and lower astigmatism during the entire follow-up. There was no significant difference in mean MRSE or mean ECC postoperatively. In both groups, mean ECC reduced significantly at one month postop, followed by a gradual linear decline between 1 and 36 months of 22.4 cells/mm2/annum (group I) and 13.32 cells/mm2/annum (group II). Overall complication rates were ≤ 10% with no significant inter-group differences. Group I patients reported lower incidence of halos at one month but more problems with night vision at one year compared with group II. Overall satisfaction was high and total incidence of reported photic phenomena was low. CONCLUSION: Both Verisyse and Veriflex pIOLs are effective in correcting myopia. The Veriflex lens demonstrated better refractive outcome; however, subclinical inflammation observed in the Veriflex group and potential influence of inflammation on ECC loss require further investigation.

Evaluation of sterile uveitis after iris-fixated phakic intraocular lens implantation.

PURPOSE: To evaluate the clinical features, and visual outcomes of sterile uveitis after iris-fixated phakic intraocular lens implantation (pIOLs) (Artisan-Artiflex(®) and Verisyse-Veriflex(®)). MATERIAL AND METHODS: In this retrospective non-comparative case series, the medical records of 117 eyes implanted with Artisan-Artiflex(®) (Ophtec BV, Groningen, Netherlands) and Verisyse-Veriflex(®) (AMO, Santa Ana, CA) iris claw phakic IOLs were analyzed for postimplantation sterile uveitis. The mean age of the 87 patients included in the study was 27.2±7.4 years. Of these patients, 56 (64.3%) were men and 31 (35.6%) were women. Patient age, gender, IOL brand type, refractive error, optic diameter, unilateral vs bilateral implantation, and anterior chamber depth were analyzed. Features of uveitis, uncorrected and best corrected visual acuity (VA) at presentation and at follow-up visits were examined. The mean follow-up time was 14.6 months (range: 6-37 months). RESULTS: Clinically significant uveitis was observed in 12 of 117 eyes (10.3%) in a total of ten patients. Of these ten patients, four (40%) were women and six (60%) were men, and the mean age was 25.1±5.3 years (range: 18-36 years). Among those with bilateral implantation, 6.9% of patients developed bilateral uveitis, while 13.8% (4 of the 29 implanted bilaterally) developed unilateral uveitis. Foldable pIOL implantation was the only variable associated with the development of uveitis (P=.03). CONCLUSION: Although the prognosis is usually benign, sterile uveitis occurred in 10.3% of patients after iris-fixated pIOL implantation. The implantation of a foldable pIOL was the only variable associated with sterile uveitis. Appropriate medical management can be effective treatment, without the need for pIOL replacement.