Management of Persistent Hypotony after Supraciliary CyPass® Implantation Using Argon Laser.
ABSTRACT: Purpose:To report a case and management of persistent hypotony with hypotony-induced maculopathy after CyPass® device implant. Background:The CyPass® was the first supraciliary ab interno device approved by FDA and commercially available. Efficacy studies showed adequate intraocular pressure (IOP)-lowering results in combination with phacoemulsification. Hypotony induced by suprachoroidal minimally invasive glaucoma surgery (MIGS) was reported to be lower than 3% in the population that comprised the COMPASS study. Case description:A 57-year-old female patient with mild open-angle glaucoma with maximum topical medical therapy who underwent sequential bilateral CyPass® implantation developed persistent hypotony. Device obstruction was induced through argon laser burns directed to the peripheral iris, and the device was no longer visible on follow-up examinations. Topical IOP-lowering medication was restarted (timolol-dorzolamide) and has since been controlled under 16 mm Hg, without progression on visual fields. Conclusion:Argon laser burns directed to the peripheral iris to induce synechiae development that produces device obstruction are an effective technique to manage persistent hypotony after supraciliary CyPass® implantation. Clinical significance:Here, authors show a novel approach for treatment of persistent hypotony secondary to CyPass® implantation. In the knowledge of the authors, this is the first report that describes a noninvasive management for this complication, and this case could help other physicians to manage similar cases. How to cite this article:Fernando DV-N, Díez-Cattini GF, Alfonso G-L, et al. Management of Persistent Hypotony after Supraciliary CyPass® Implantation Using Argon Laser. J Curr Glaucoma Pract 2019;13(3):116-118.
Project description:Objective:To describe the safety and effectiveness of CyPass supraciliary microstent implantation alone in eyes with open-angle glaucoma (OAG) followed up for up to 3 years. Methods and analysis:This registry study included subjects with primary or secondary OAG who underwent CyPass Micro-Stent implantation alone at 12 sites in four European countries to reduce intraocular pressure (IOP) and/or use of IOP-lowering medications. The primary safety outcome was the incidence of adverse events. Secondary efficacy outcomes included mean changes from baseline in IOP and IOP-lowering medications. Eyes were subgrouped into those with low (< 21 mm Hg) and high (> 21 mm Hg) baseline IOP. Results:This study included 225 eyes of 178 patients, with mean baseline IOP of 22.6 ± 6.7 mm Hg and a mean 2.2 ± 1.2 medications per eye. Common ocular adverse events included device obstruction (10.2%), IOP elevation > 10 mm Hg during follow-up (8.9%), retinal complications (4.4%) and loss of > 2 lines of best-corrected visual acuity (2.7%). Seventy-one eyes (31.6%) required secondary glaucoma surgery, with trabeculectomy (33 eyes) and second microstent implantation (13 eyes) being most common. At months 6-36, mean IOP reductions ranged from 4.4 to 5.1 mm Hg (15.8%-19.5%) and mean medication reductions from 0.2 to 1.2 (9.1%-54.5%). Mean IOP reduction was greater in eyes with higher than lower baseline IOP. Both subgroups showed reductions of 0.5-1.0 medication at 12-18 months. Conclusion:CyPass microstent implantation demonstrated a safety profile consistent with other minimally invasive glaucoma surgeries and effectively lowered IOP for up to 3 years in eyes with OAG.
Project description:PurposeTo report the results of subconjunctival ologen Collagen Matrix implantation to manage ocular hypotony after filtration glaucoma surgery.Patients and methodsThis retrospective observational case series included 12 consecutive implantations of ologen in nine eyes of nine Japanese subjects (five men, four women; mean age±SD, 72.1±12.7 years) who underwent subconjunctival implantation of the device to treat hypotony after glaucoma filtration surgery. Demographic data and surgical results were collected by chart review.ResultsThe subjects included six patients who underwent trabeculectomy and three who underwent an EX-PRESS shunt surgery. The duration between the last glaucoma surgery and the initial ologen implantation was longer than 2 years in seven (78%) eyes. Bleb leakage in five (56%) eyes preoperatively stopped in all cases by 8 days after the device implantation. After the initial implantation, three (33.3%) eyes required a second implantation of ologen because of insufficient efficacy. After a mean follow-up of 12.6±6.8 months, the mean preoperative intraocular pressure (IOP) of 3.8±2.7?mmHg increased significantly (P=0.0001) to 9.0±3.2?mmHg; no eye required glaucoma medication to control the IOP. No vision-threatening complications developed in association with the treatment.ConclusionWhen conservative management failed, subconjunctival implantation of ologen Collagen Matrix in combination with bleb revision can be a useful therapeutic option for ocular hypotony after glaucoma filtration surgery.
Project description:Primary open-angle glaucoma is estimated to affect 3% of the population aged 40-80 years. Trabeculectomy is considered the gold standard in surgical management of glaucoma; however, it is a technically complex procedure that may result in a range of adverse outcomes. Device-augmented, minimally invasive procedures (micro-invasive glaucoma surgeries, MIGS) have been developed aiming for safer and less invasive intraocular pressure (IOP) reduction compared with traditional surgery.This paper presents results from a systematic literature review conducted in accordance with National Institute for Health and Care Excellence requirements for the Medical Technology Evaluation Programme via multiple databases from 2005 to 2016. For clinical outcomes, randomized clinical trials (RCTs) comparing MIGS with trabeculectomy or other therapies, observational studies, and other non-RCTs were included. Clinical outcomes reviewed were the change from baseline in mean IOP levels and change in topical glaucoma medication. Safety was assessed by reported harm and adverse events. For economic evidence, trials on cost-effectiveness, cost-utility, cost-benefit, cost-consequences, cost-minimization, cost of illness, and specific procedure costs were included. Risk of bias was assessed for clinical studies using the Cochrane Risk of Bias tool.A total of nine RCTs (seven iStents®, one Hydrus®, and one CyPass®), seven non-RCTs (three iStent®, three CyPass®, and one Hydrus®), and 23 economic studies were analyzed. While various forms of trabeculectomy can achieve postoperative IOP of between 11.0 and 13.0 mmHg, MIGS devices described in this review were typically associated with higher postoperative IOP levels. In addition, MIGS devices may result in increased hypotony rates or bleb needling in subconjunctival placed devices, requiring additional medical resources to manage. There is limited available evidence on the cost-effectiveness of MIGS and therefore it remains unclear whether the cost of using MIGS is outweighed by cost savings through decreased medication and need for further interventions.Larger randomized trials and real-world observational studies are needed for MIGS devices to better assess clinical and economic effectiveness. Given the shortage of published data and increasing use of such procedures, living systematic reviews may help to provide ongoing and timely evidence-based direction for clinicians and decision makers. This review highlights the current unmet need for treatments that are easy to implement and reduce long-term IOP levels without increasing postoperative aftercare and cost.Santen GmbH, Germany.
Project description:PRECIS:In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. PURPOSE:This study evaluates the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627) for surgical treatment of primary open-angle glaucoma in patients refractory to topical hypotensive medications. METHODS:In a prospective, interventional, single-arm, multicenter, European study (STAR-II), MINIject was successfully implanted in a stand-alone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal IOP ?21 and >5?mm?Hg with ?20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361. RESULTS:At the 6-month follow-up, the primary endpoint was fulfilled, with 75.9% of patients reaching prospectively defined success. The mean IOP was reduced by 40.2% (9.9?mm?Hg) to 14.7±6.0?mm?Hg at 6 months from 24.6±3.8?mm?Hg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% from 2.9±1.2 at baseline to 1.0±1.3. Furthermore, 79.3% of the patients had mean IOP ?18?mm?Hg, 82.8% achieved a ?20% IOP reduction, and 55.2% were medication free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion, and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density. CONCLUSION:Ab-interno supraciliary surgical implantation using MINIject DO627 in a stand-alone procedure significantly lowers IOP by 40% at the 6-month follow-up, while reducing the need for IOP-lowering medication.
Project description:Purpose:Microinvasive glaucoma surgery and its associated devices remain a field of continued interest and innovation in the management of patients with glaucoma. While a range of outflow optimisation devices have been designed, the efficacy and safety and these devices remains to be proven, particularly in the long term. Observations:The authors present the first reported case to our knowledge of bilateral hypertensive crisis associated with CyPass® Micro-stent insertion two months post-operation and its resultant management. Conclusions and importance:Despite the recall of the CyPass Micro-stent (Alcon, Fort Worth, Texas, USA), further clinical experience in the use of these and similar stents is required. Possible hypotheses explaining this phenomenon are also presented, the most likely being sudden closure of the suprachoroidal space.
Project description:To report a case of recurrent hypotony and choroidal effusion following trabeculectomy.A 70 year old male with advanced pseudoexfoliation glaucoma in both eyes underwent trabeculectomy in the left eye. Initially intraocular pressure (IOP) was controlled without topical therapy, but dorzolamide-timolol and brimonidine were added when IOP elevated above target. Aqueous suppressant glaucoma medications were thought to cause three episodes of hypotony resolving with discontinuation of these medications. Conclusions and Importance: Although hypotony and choroidal detachment associated with the use of aqueous suppressants is rare, it should be considered in patients with hypotony of unclear etiology following a glaucoma filtering procedure. Aqueous suppressants should be discontinued and it is recommended that the glaucoma drop regimen be switched to non-aqueous suppressants in patients with these findings.
Project description:To understand the reasons for refusal of fellow eye surgical treatment for glaucoma after first eye trabeculectomy.Post hoc analysis of data collected in a multicenter, randomized clinical trial.Data from participants in the Collaborative Initial Glaucoma Treatment Study (CIGTS) who were randomized to and underwent initial trabeculectomy on their study eye, and whose fellow eye was eligible for surgical treatment, were analyzed. Participant demographic data and characteristics, surgical data from the study eye, and quality-of-life survey results were compared between groups that received or refused trabeculectomy in their fellow eye. The main outcome measure was patient refusal of fellow eye surgery for glaucoma.Of 159 participants who were randomized to and underwent trabeculectomy on their study eye and had a fellow eye that was eligible for surgery, 30 (19%) refused fellow eye surgery. Eligible patients who refused fellow eye trabeculectomy did not differ significantly in visual function or local eye symptoms from those that underwent fellow eye trabeculectomy (all P > .05). In a multivariable analysis of data, increased fellow eye preoperative intraocular pressure (IOP) was associated with decreased odds (OR = 0.89, P = .0188), study eye hypotony at 3 months postoperatively was associated with increased odds (OR = 7.24, P = .0125), and argon suture lysis procedure was associated with decreased odds (OR = 0.38, P = .0385) of surgery refusal.Refusal of fellow eye surgery was not uncommonly encountered in the CIGTS. Those who refused fellow eye surgery had lower fellow eye IOP and were more likely to have had hypotony after study eye trabeculectomy.
Project description:To compare two surgical approaches for treating encapsulated blebs after trabeculectomy with mitomycin C, in terms of the development of intraocular pressure and progression of glaucoma in a long-term follow up: 1. bleb needling alone vs. 2. a combined approach of needling with additional transconjunctival scleral flap sutures, to prevent early ocular hypotony.Forty-six patients with failing blebs after trabeculectomy with mitomycin C were enrolled in this study. Patients received either needling revision alone (group 1; n = 23) or a combined needling with additional transconjuctival flap sutures, if intraoperatively the intraocular pressure was estimated to be low (group 2; n = 23). Intraocular pressure (IOP), visual acuity, visual fields, and optic nerve head configuration by means of Heidelberg Retina Tomograph (HRT®) were analysed over time. Results from both groups were compared using Mann-Whitney U-test for single timepoints.IOP did not differ significantly between the two groups during follow-up at three months (P = 0.13), six months (P = 0.12), one year (P = 0.92) and two years (P = 0.57) after surgery. Furthermore, there was no significant difference in the course of glaucoma concerning the optic nerve anatomy between the two groups (Rim Area Change in the Moorfields Regression Analysis of HRT®) till two years after surgery (P = 0.289). No functional impairment in visual acuity and visual fields was found in the groups of the study.Single needling procedure is a standard successful method for restoring the function of encapsulated blebs. Postoperative hypotony represents a possible hazard, which can be minimized by additional transconjunctival flap sutures. Long-term results suggest that this modification is equally effective in lowering the IOP and preventing the progression of glaucoma as the standard needling procedure. To our knowledge this is the first study to investigate the long-term effect of tranconjunctival sutures for the prevention of hypotony.
Project description:Intraoperative intraocular bleeding can present a major challenge during anterior segment operations, such as cataract and glaucoma surgery. In the presence of significant intraocular bleeding, the surgeon may be unable to proceed if the bleeding cannot be controlled. Uncontrolled bleeding may also result in intraoperative or postoperative complications. Intracameral injection of phenylephrine was used in three consecutive cases of intraoperative anterior chamber bleeding during cataract surgery, one of which was combined with CyPass® Micro-Stent insertion. This resulted in complete cessation of bleeding within a minute of the injection. No further intraoperative or postoperative hemorrhage was seen. As far as we know, this is the first report of intracameral phenylephrine use intraoperatively to successfully stop anterior chamber bleeding, enabling safe completion of surgery.
Project description:Trabeculectomy has been the traditional primary surgical therapy for open-angle glaucoma. While trabeculectomy is effective in lowering intraocular pressure, complications associated with the procedure have motivated the development of alternative techniques and devices, including the EX-PRESS Glaucoma Filtration Device. This review describes the efficacy, safety, complication rates, and potential advantages and disadvantages of the EX-PRESS Glaucoma Filtration Device. EX-PRESS implantation is technically simpler compared with that of trabeculectomy, with fewer surgical steps. Vision recovery has been more rapid after EX-PRESS implantation compared with trabeculectomy. Intraocular pressure variation is lower during the early postoperative period, indicating a more predictable procedure. While efficacy of the EX-PRESS implant has been comparable to trabeculectomy, postoperative complications appear less common after EX-PRESS implantation compared with trabeculectomy. The EX-PRESS Glaucoma Filtration Device appears to be safe and effective in the surgical management of open-angle glaucoma.