Publications by authors named "Carl Awh"
Purpose: To evaluate for the presence, severity, and type of exudation at each study visit for a subgroup of patients with neovascular age-related macular degeneration from the Archway and Portal trials.
Design: Retrospective analysis of prospectively obtained data.
Methods: Spectral-domain optical coherence tomography scans from each study visit of 44 patients from the Port Delivery System (PDS) arm and 32 patients from the monthly injection arm of Archway were evaluated, and composites of horizontal scans through the fovea were created.
This work compares physician reimbursements for retinal detachment (RD) surgery with office-based patient care. A theoretical model was constructed from the physician's perspective for performing a 90-minute uncomplicated RD surgery with its associated perioperative work in the global period (Current Procedural Terminology code 67108) compared with managing 40 patients per 8-hour clinic day in the equivalent time period. The reimbursement rates were based on the 2019 values set by the US Centers for Medicare and Medicaid Services (CMS).
View Article and Find Full Text PDFPurpose: To assess the safety and efficacy of biweekly (every 2 weeks) intravitreal aflibercept injections (IAI) 2 mg in eyes with refractory neovascular age-related macular degeneration (NVAMD).
Methods: A prospective, single-arm, interventional study was conducted. Eyes with refractory NVAMD received six biweekly IAIs through week 12, followed by a 4-week treatment pause until week 16.
A Comparison of Peel-Induced Maculopathy Following ILM Peeling Using a Microvacuum Pick Versus Forceps.
Ophthalmic Surg Lasers Imaging Retina
January 2023
Objective: To compare peel-induced maculopathy (PIM) using surgical forceps versus the microvacuum pick (MVP).
Methods: Consecutive eyes undergoing internal limiting membrane (ILM) peeling using either the MVP or forceps were assessed. En face optical coherence tomography (OCT) images at the level of the nerve fiber layer were generated for 6-month postoperative visit.
Purpose: To provide strategies for the management of key ocular adverse events (AEs) that may be encountered with the Port Delivery System with ranibizumab (PDS) in practice and provide recommendations that may mitigate such AEs based on clinical trial experiences and considerations from experts in the field.
Design: Safety evaluation based on the phase 2 Ladder (NCT02510794) and phase 3 Archway (NCT03677934) trials of the PDS.
Methods: The PDS implant is a permanent, indwelling, and refillable ocular drug delivery system that requires standardized procedural steps for its insertion and refill-exchange procedures, which evolved during the PDS clinical program.
Implant Insertion Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Pearls.
Ophthalmic Surg Lasers Imaging Retina
May 2022
Objective: To describe the Port Delivery System with ranibizumab implant insertion procedure.
Methods: A surgical procedure based on the clinical trial program in patients with retinal diseases.
Results: An infusion line is placed in the infero-temporal quadrant; a superotemporal quadrant corneal traction suture is recommended.
Purpose: This work analyzes data from a series of surveys developed by the American Society of Retina Specialists (ASRS) that assesses the impact of COVID-19 on physicians, their practices, and their patients.
Methods: Five surveys were sent by the ASRS between March and July 2020 to more than 2600 US and international retina specialists. Data and trends from these surveys were analyzed.
Purpose: Intravitreal injection is the most frequently performed eye procedure in the world and is an essential component in the management of sight-threating retinal diseases and conditions. Given the seriousness and range of diseases treated and the risks of the procedure, retina specialists must weigh the pros and cons of each individual treatment. Complexities guiding injection treatment are multifaceted and involve patient-history review, careful examination, diagnostic testing selection and interpretation, customized medical decision-making, and follow-up considerations.
View Article and Find Full Text PDFThe real-world performance of a home telemonitoring strategy (ForeseeHome AMD Monitoring System, Notal Vision, Inc.,Manassas VA, USA) was evaluated and compared to the device arm of the AREDS2-HOME study among patients with intermediate AMD (iAMD) who converted to neovascular AMD (nAMD). All patients with confirmed conversion to nAMD who used the home monitoring system from 10/2009 through 9/2018 were identified by Notal Vision Diagnostic Clinic's medical records.
View Article and Find Full Text PDFPurpose: Current retinal tamponade strategies are limited by anatomic considerations (retinal break location), durability (short-term vs need for removal), and patient adherence (positioning, travel/altitude restrictions). Here we describe the preclinical safety and toxicology of a novel biodegradable hydrogel tamponade agent (PYK-1105) with the potential to improve both patient experience and outcomes after retina surgery.
Methods: We studied in vitro performance to assess hydrogel gelation time, modulus, viscosity, degradation time, refractive index, and transmittance.
Purpose: The safety and efficacy of X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor, was investigated for treatment of wet age-related macular degeneration (AMD) in a phase II clinical trial.
Methods: This phase II, randomised, double-masked, placebo-controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two intravitreal injections of anti-VEGF therapy. Subjects were randomised equally into four groups that received either daily 50mg, 100mg or 200mg dosages of X-82 or a placebo tablet.
A Microsurgical Vacuum Pick for Membrane Peeling Without Forceps During Vitreoretinal Surgery.
Ophthalmic Surg Lasers Imaging Retina
March 2020
Background And Objective: To describe a new device and method for peeling membranes without forceps during vitreoretinal surgery.
Materials And Methods: A novel micro-vacuum-pick (MVP) was used to peel internal limiting membrane (ILM) and/or epiretinal membrane (ERM) in 24 consecutive pars plana vitrectomy procedures. The MVP was used to create an edge in the membrane, strip the membrane from the retinal surface, and evacuate the membrane from the eye through the lumen of the device using active aspiration.
Purpose: To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) treatment.
Design: Phase 2, multicenter, randomized, active treatment-controlled clinical trial.
Participants: Patients diagnosed with nAMD within 9 months who had received 2 or more prior anti-vascular endothelial growth factor intravitreal injections and were responsive to treatment.
Purpose Of Review: To review the development of hypersonic vitrectomy and present the first case series in the United States.
Recent Findings: From 27 September 2017 to 4 December 2017, 64 patients underwent hypersonic vitrectomy with 20 patients having conventional 23-ga vitrectomy for comparison. The preoperative diagnoses ranged from vitreous opacities to rhegmatogenous retinal detachments.
Background: An interaction between genetic variants in complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) and high-dose zinc supplementation on progression to advanced age-related macular degeneration (AMD) exists. Because cognitive impairment (CI) is associated with AMD, we used data from the Women's Health Initiative (WHI) to search for a zinc/genetics interaction.
Objective: To study the interaction of chronic zinc supplementation with genetic variants in CFH and ARMS2 on the development of CI.
We evaluated the influence of an antioxidant and zinc nutritional supplement [the Age-Related Eye Disease Study (AREDS) formulation] on delaying or preventing progression to neovascular AMD (NV) in persons with age-related macular degeneration (AMD). AREDS subjects ( = 802) with category 3 or 4 AMD at baseline who had been treated with placebo or the AREDS formulation were evaluated for differences in the risk of progression to NV as a function of () and () genotype groups. We used published genetic grouping: a two-SNP haplotype risk-calling algorithm to assess , and either the single SNP rs10490924 or 372_815del443ins54 to mark risk.
View Article and Find Full Text PDFImportance: Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data.
Objective: To investigate whether bevacizumab is noninferior to aflibercept for the treatment of macular edema secondary to central retinal or hemiretinal vein occlusion.
Objective: To evaluate the impact of complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) risk alleles on the observed response to components of the Age-Related Eye Disease Study (AREDS) formulation.
Design: Genetic and statistical subgroup analysis of a randomized, prospective clinical trial.
Participants: White patients from the AREDS with category 3 or 4 age-related macular degeneration (AMD) with available DNA (n = 989).
Objective: The Age-Related Eye Disease Study (AREDS) demonstrated that antioxidant and zinc supplementation decreases progression to advanced age-related macular degeneration (AMD) in patients with moderate to severe disease. We evaluated the interaction of genetics and type of nutritional supplement on progression from moderate to advanced AMD.
Design: Genetic analysis of a randomized, prospective clinical trial.