One-Year Efficacy and Safety of the PAUL Glaucoma Implant Using a Standardized Surgical Protocol.

PRCIS: The PAUL Glaucoma Implant is an effective intraocular pressure (IOP)-lowering device with an acceptable safety profile. Its design as a nonvalved device with a small tube diameter using a vicryl ligation suture around the tube that is posteriorly reabsorbed instead of an ab luminal stent makes it an option in cases selected for glaucoma drainage device implantation. PURPOSE: The aim was to determine the 1-year efficacy and safety of PAUL Glaucoma Implant using a uniform, standardized surgical procedure. MATERIALS AND METHODS: Retrospective, cohort study. Patient charts were screened between December 2018 and January 2020, with inclusion requiring a minimum follow-up of 12 months. Primary outcome was IOP-lowering at 12 months, with surgical success defined as ≤18 mm Hg and at least 30% reduction and higher than 5 mm Hg. Absolute success was achieved if no IOP-lowering medication was needed and qualified success if otherwise. Safety outcomes were also analyzed. A standardized protocol was followed in all cases, which included mitomycin C application and 1 vicryl ligation of the tube. RESULTS: A total of 24 eyes from 21 patients fulfilled inclusion criteria. Median patient age at time of surgery was 42 years (range: 1 to 76 y). IOP decreased from 31.4 (10.0) mm Hg in preoperative period to 12.5 (4.3) mm Hg in the last follow-up (P<0.001). Qualified success criteria were fulfilled by 75% of cases, while absolute success was 33%. The mean number of IOP-lowering drugs used before surgery was 3.0 and 0.9 at the 12-month visit (P<0.001). No postoperative hypotony requiring intervention was recorded. CONCLUSIONS: PAUL Glaucoma Implant appears to be a safe and effective glaucoma drainage implant for the treatment of moderate and advanced glaucoma.

Efficacy of biofeedback rehabilitation based on visual evoked potentials analysis in patients with advanced age-related macular degeneration.

Age-related macular degeneration (AMD) is a progressive and degenerative disorder of the macula. In advanced stages, it is characterized by the formation of areas of geographic atrophy or fibrous scars in the central macula, which determines irreversible loss of central vision. These patients can benefit from visual rehabilitation programmes with acoustic "biofeedback" mechanisms that can instruct the patient to move fixation from the central degenerated macular area to an adjacent healthy area, with a reorganization of the primary visual cortex. In this prospective, comparative, non-randomized study we evaluated the efficacy of visual rehabilitation with an innovative acoustic biofeedback training system based on visual evoked potentials (VEP) real-time examination (Retimax Vision Trainer, CSO, Florence), in a series of patients with advanced AMD compared to a control group. Patients undergoing training were subjected to ten consecutive visual training sessions of 10 min each, performed twice a week. Patients in the control group did not receive any training. VEP biofeedback rehabilitation seems to improve visual acuity, reading performances, contrast sensitivity, retinal fixation and sensitivity and quality of life in AMD patients.

Biofeedback Low Vision Rehabilitation with Retimax Vision Trainer in Patients with Advanced Age-related Macular Degeneration: A Pilot Study.

PURPOSE: To evaluate the effectiveness of Visual Evoked Potential (VEP) biofeedback rehabilitation in selected low vision patients with advanced age-related macular degeneration (AMD). DESIGN: Retrospective observational cohort study. METHODS: Patients affected by advanced AMD, central macular atrophy with unstable fixation and best corrected visual acuity (BCVA) between 20/100 and 20/320 were considered. Selected patients underwent fundus photography and microperimetry with fixation analysis for the selected eye (highest BCVA). Ten consecutive training sessions of 10 min each were performed twice a week in the selected eye with Retimax Vision Trainer (CSO, Florence). BCVA, reading acuity and reading speed, contrast sensitivity, fixation, retinal sensitivity and quality of life questionnaire (VFQ-25) were evaluated at baseline and 7 days following the final session. RESULTS: Significant improvements in terms of BCVA [p = .011], reading speed [p = .007], VFQ-25 score [p = .007], retinal sensitivity [p = .021] and fixation stability in the central 2° and 4° [p = .048; p = .037] post-treatment were observed for the 9 patients enrolled, with insignificant improvements observed in reading acuity and contrast sensitivity [p = .335; p = .291]. CONCLUSIONS: Preliminary results support VEP biofeedback rehabilitation improvements for visual function and quality of life in advanced AMD patients with low vision.