Invasive Treatments for Low Back Disorders.

OBJECTIVE: This abbreviated version of the American College of Occupational and Environmental Medicine's Low Back Disorders guideline reviews the evidence and recommendations developed for invasive treatments used to manage low back disorders. METHODS: Comprehensive systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking and often relied on analogy to other disorders for which evidence exists. A total of 47 high-quality and 321 moderate-quality trials were identified for invasive management of low back disorders. RESULTS: Guidance has been developed for the invasive management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 49 specific recommendations. CONCLUSION: Quality evidence should guide invasive treatment for all phases of managing low back disorders.

Non-Invasive and Minimally Invasive Management of Low Back Disorders.

OBJECTIVE: This abbreviated version of the American College of Occupational and Environmental Medicine's (ACOEM) Low Back Disorders Guideline reviews the evidence and recommendations developed for non-invasive and minimally invasive management of low back disorders. METHODS: Systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking. A total of 70 high-quality and 564 moderate-quality trials were identified for non-invasive low back disorders. Detailed algorithms were developed. RESULTS: Guidance has been developed for the management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 121 specific recommendations. CONCLUSION: Quality evidence should guide treatment for all phases of managing low back disorders.

Development of surgical techniques for implantation of a wireless intraocular epiretinal retina implant in Göttingen minipigs.

BACKGROUND: The aim of this study was to develop surgical methods for the implantation of a wireless intraocular epiretinal retina implant (EPI RET3) in Göttingen minipigs. This animal model resembles closely the anatomical conditions in humans, and is thus suitable for investigating the EPI RET3 implant as designed for the application in humans. METHODS: Phacoemulsification and vitrectomy was performed on the right eye of 16 Göttingen minipigs under general anesthesia. The implants, consisting of a receiver module and an electrode array connected via a flexible micro cable, were inserted through a corneoscleral incision. The receiver module was placed into the sulcus ciliaris and the electrode array was fixed onto the retina temporal to the optic disc with a retinal tack. Minipigs were monitored for intra- and postoperative ocular complications. Follow-up times were 3 (seven minipigs) and 12 weeks (nine minipigs). RESULTS: Implantation was successfully performed in all 16 minipigs. The complete implantation surgery required on average 2 hours. Intraoperative findings were a minor hemorrhage of the anterior chamber angle in two eyes, one minor iris hemorrhage, and one minor punctiform retinal hemorrhage, which were all reversible. Postoperatively, the corneoscleral incision showed good wound healing in all eyes. Intraocular reactions included mainly fibrin exudation (six eyes) and formation of iris synechiae with the receiver module of the implants (three eyes). CONCLUSIONS: The performed implantation procedures of the intraocular EPI RET3 implant are feasible and reproducible within an acceptable surgical time. The development of inflammatory responses is a specific predisposition of the minipig following any intraocular intervention; nevertheless, the surgical techniques should be further improved to minimize procedure-related reactions. Our results provide a step towards the application of the EPI RET3 system in clinical studies.

Stimulation with a wireless intraocular epiretinal implant elicits visual percepts in blind humans.

PURPOSE: Electrical stimulation of retinal neurons has been shown to be a feasible way to elicit visual percepts in patients blind from retinal degenerations. The EPIRET3 retinal implant is the first completely wireless intraocular implant for epiretinal stimulation. Stimulation tests have been performed during a clinical trial that was carried out at the eye clinics of Aachen and Essen to evaluate the safety and the efficacy of the implant. METHODS: Six legally blind retinitis pigmentosa patients were included in the study. In accordance with the regulations laid down in the study protocol, three 1-hour perceptual tests for each subject were performed within 4 weeks of surgery. Stimuli were charge-balanced square current pulses of various durations and current amplitudes. RESULTS: All subjects reported visual percepts as a result of electrical stimulation by the implant. Thresholds for eliciting visual percepts varied between them but were below the safety limits of electrical stimulation. Stimulation success depended stronger on pulse duration than on current amplitude or total charge delivered. Subjects were able to discriminate between stimulation patterns of different orientations or at different locations of the electrode array. CONCLUSIONS: The EPIRET3 system is suitable to elicit visual percepts in blind retinitis pigmentosa patients.

Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial.

PURPOSE: Visual sensations in patients with blindness and retinal degenerations may be restored by electrical stimulation of retinal neurons with implantable microelectrode arrays. A prospective trial was initiated to evaluate the safety and efficacy of a wireless intraocular retinal implant (EPIRET3) in six volunteers with blindness and RP. METHODS: The implant is a remotely controlled, fully intraocular wireless device consisting of a receiver and a stimulator module. The stimulator is placed on the retinal surface. Data and energy are transmitted via an inductive link from outside the eye to the implant. Surgery included removal of the lens, vitrectomy, and implantation of the EPIRET3 device through a corneal incision. The clinical outcome after implantation and explantation of the device was determined. The implant was removed after 4 weeks, according to the study protocol. RESULTS: Implantation was successful in all six patients. While the anterior part was fixed with transscleral sutures, the stimulating foil was placed onto the posterior pole and fixed with retinal tacks. The implant was well tolerated, causing temporary moderate postoperative inflammation, whereas the position of the implant remained stable until surgical removal. In all cases explantation of the device was performed successfully. Adverse events were a sterile hypopyon effectively treated with steroids and antibiotics in one case and a retinal break in a second case during explantation requiring silicone oil surgery. CONCLUSIONS: The EPIRET3 system can be successfully implanted and explanted in patients with blindness and RP. The surgical steps are feasible, and the postoperative follow-up disclosed an acceptable range of adverse events.