Purpose: To compare the coaxial light intensity required during cataract surgery and rate of postoperative visual recovery, with surgical visualization achieved with a traditional analog operating microscope compared with a 3D digital visualization system. Setting: Weill Cornell Medical Center, New York Presbyterian Hospital, New York, New York. Design: Retrospective, consecutive, single-surgeon series. Methods: Patients undergoing femtosecond laser–assisted cataract surgery were retrospectively grouped into either: (1) visualization using the binoculars of a standard operating microscope (traditional group) or (2) visualization using a 3D digital visualization system affixed to the same operating microscope (digital group). Note was made in each case of light intensity used, light exposure time, intraoperative and/or postoperative complications, and postoperative visual acuities. Results: The study comprised 24 eyes in the traditional group and 27 eyes in the digital group. There were no intraoperative or postoperative complications in either group and no difference in mean light exposure time, but the mean light intensity used in the digital group was significantly less (18.5% ± 1.5%) than that in the traditional group (43.3% ± 3.7%; P < .001). Furthermore, the digital group achieved a postoperative day 1 visual acuity that was within 2 lines of the postoperative month 1 visual acuity a greater percentage of time than that in the traditional group (81.5% of eyes vs 54.2% of eyes; P = .04). Conclusions: Light intensity was significantly decreased in patients who underwent cataract surgery assisted by the 3D digital visualization platform without an increase in complications or surgical time and possibly with a faster postoperative visual recovery.
Inherited retinal diseases (IRDs) are a genetically variable collection of devastating disorders that lead to significant visual impairment. Advances in genetic characterization over the past two decades have allowed identification of over 260 causative mutations associated with inherited retinal disorders. Thought to be incurable, gene supplementation therapy offers great promise in treating various forms of these blinding conditions. In gene replacement therapy, a disease-causing gene is replaced with a functional copy of the gene. These therapies are designed to slow disease progression and hopefully restore visual function. Gene therapies are typically delivered to target retinal cells by subretinal (SR) or intravitreal (IVT) injection. The historic Food and Drug Administration (FDA) approval of voretigene neparvovec for RPE65-associated Leber's congenital amaurosis (LCA) spurred tremendous optimism surrounding retinal gene therapy for various other monogenic IRDs. Novel disease-causing mutations continue to be discovered annually, and targeted genetic therapy is now under development in clinical and preclinical models for many IRDs. Numerous clinical trials for other IRDs are ongoing or have recently completed. Disorders being targeted for genetic therapy include retinitis pigmentosa (RP), choroideremia (CHM), achromatopsia (ACHM), Leber's hereditary optic neuropathy, usher syndrome (USH), X-linked retinoschisis, and Stargardt disease.Here, we provide an update of completed, ongoing, and planned clinical trials using gene supplementation strategies for retinal degenerative disorders.
Patient safety is a primary priority in the conduction of retinal gene therapy trials. An understanding of risk factors and mitigation strategies for post-procedure complications is crucial for the optimization of gene therapy clinical trial protocols. In this review, we synthesize the literature on ocular delivery methods, vector platforms, and treatment-emergent adverse effects in recent gene therapy clinical trials for inherited retinal diseases.
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