The gelatin stent reduced IOP and medication use without raising unexpected safety concerns, offering a minimally invasive surgical option for refractory glaucoma patients.
The 24-month results demonstrate that GATT is relatively safe and effective in treating various forms of open-angle glaucoma. The long-term results for GATT are relatively equivalent to those previously reported for GATT and ab externo trabeculotomy studies.
The preliminary results and safety for GATT, a minimally invasive conjunctival sparing circumferential trabeculotomy, are promising and at least equivalent to previous results for ab externo trabeculotomy for the treatment of PCG and JOAG. All eyes in the study were considered a clinical success.
for the INN005 Study Group* Purpose: To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG).Design: One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe.Participants: Eligible patients were aged 40e85 years with intraocular pressure (IOP) !15 and 40 mmHg and mild-to-severe POAG inadequately controlled on maximum tolerated medical therapy.Methods: Patients were randomized 3:1 to undergo stand-alone MicroShunt implantation or trabeculectomy, both performed with adjunctive mitomycin C (0.2 mg/ml for 2 minutes).Main Outcome Measures: The primary effectiveness end point was surgical success, defined as !20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events.Results: Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation, À12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP AE standard deviation decreased from 21.1 AE 4.9 mmHg at baseline to 14.3 AE 4.3 mmHg (À29.1%; P < 0.01) at year 1, with a mean of 0.6 AE 1.1 glaucoma medications (baseline 3.1 AE 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 AE 5.0 mmHg to 11.1 AE 4.3 mmHg (À45.4%; P < 0.01), with a mean of 0.3 AE 0.9 glaucoma medications (baseline 3.0 AE 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P < 0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients.Conclusions: Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications. Ophthalmology 2021;-:1e12
Glaucoma is a preventable cause of blindness if timely effective and successful treatment is provided. Patient adherence to the medication is a constant challenge that is now recognized as an essential component to treatment. Several studies have demonstrated that patients are more likely to be adherent to their medication if they understand the disease and the rationale for treatment and if their treatment regimen is simplified. Additionally, using eye drops has its own set of challenges that must be recognized and addressed at the clinical level. Although numerous socioeconomic factors are associated with poor adherence, these factors must be addressed at the societal level. Maximizing patient adherence to medication has the potential to reduce the number of surgical interventions required to treat glaucoma, prevent unnecessary vision loss, and save the overall healthcare system money in the long run.
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