Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent.

PURPOSE: To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery. PATIENTS AND METHODS: Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP): ≥21 mm Hg (cohort 1, n=65) or <21 mm Hg (cohort 2, n=102). Glaucoma medications were discontinued or tapered at surgery, and restarted at investigator discretion. The main postoperative outcome measures were adverse events, IOP changes, and number of IOP-lowering medications. RESULTS: Mean±SD follow-up was 294±121 days. No major intraoperative or postoperative complications occurred. Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP-lowering medications was 2.0±1.1. Cohort 1 showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage; cohort 2 demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline). Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes, respectively. Two subjects developed mild transient hyphema, and none exhibited prolonged inflammation, persistent hypotony, or hypotony maculopathy. CONCLUSIONS: CyPass Micro-Stent implantation, combined with cataract surgery, resulted in minimal complications and reduced IOP and IOP-lowering medication use at 12 months postoperatively.

Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study.

PURPOSE: To evaluate the safety and efficacy of a supraciliary micro-stent (CyPass Micro-Stent; Transcend Medical, Menlo Park, California, USA) for surgical treatment of glaucoma in patients refractory to topical medications. DESIGN: Multicenter, single-arm interventional study. METHODS: Patients with open-angle glaucoma (Shaffer Grade 3 and 4) and uncontrolled medicated intraocular pressure (IOP) >21 mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled. Glaucoma medications were discontinued at surgery and resumed at investigator discretion. CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach. Adverse events, postoperative IOP changes, and need for IOP-lowering medications during the first 12 postoperative months (12M) were monitored. RESULTS: Sixty-five eyes were enrolled, and 55 were available at 12M, accounting for loss to follow-up and early termination. Baseline IOP was 24.5 ± 2.8 mm Hg, and the mean number of medications recorded was 2.2 ± 1.1. There were no serious intraoperative events or major adverse events (eg, retinal or choroidal detachment, persistent uveitis, persistent hyphema, hypotony maculopathy). The most common adverse events included IOP increases >30 mm Hg beyond 1 month (11%, 7/65), transient hyphema (6%, 4/65), and cataract progression (12%, 5/41 phakic eyes). Mean IOP was 16.4 ± 5.5 mm Hg at 12 months-a 34.7% reduction (P < .0001). Mean medication usage also decreased from baseline to a mean of 1.4 ± 1.3 medications at 12M (P = .002). In eyes originally indicated for conventional glaucoma surgery, no secondary surgery was performed in 83% (53/64). CONCLUSION: Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma, precluding the need for more invasive glaucoma surgery in >80% of patients at 1 year, thereby reducing postoperative glaucoma surgical complications.

Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery.

PURPOSE: To evaluate the safety of a new suprachoroidal device, the Cypass micro-stent, for the surgical treatment of open-angle glaucoma (OAG) implanted in conjunction with cataract surgery. SETTING: Multicenter clinical study. DESIGN: Prospective interventional case series. METHODS: This is an interim report of an ongoing safety study. Patients with OAG glaucoma (Shaffer grade 3 and 4) who were also candidates for cataract surgery in the affected eye had standard phacoemulsification followed by micro-stent implantation in the supraciliary space. Included were patients with uncontrolled (≥ 21 mm Hg, Cohort 1) or controlled (<21 mm Hg, Cohort 2) medicated intraocular pressure (IOP) at baseline. Glaucoma medications were discontinued at surgery and resumed at the discretion of each investigator. Measures included adverse events/complications and postoperative changes in IOP or medication. RESULTS: The mean baseline medicated IOP was 21.1 mm Hg ± 5.91 (SD); the mean number of IOP-lowering medications was 2.1 ± 1.1 (N = 184). There were no major events such as retinal or choroidal detachment or endophthalmitis. The most common complications were transient early hypotony (13.8%) and transient IOP increase (10.5%). Uncontrolled patients (n = 57) had a 37% IOP reduction (P<.001), with more than a 50% reduction in glaucoma medications at 6 months (P<.001). Intraocular pressure-controlled patients (n = 41) had a 71.4% reduction in glaucoma medications (P<.001). CONCLUSION: Initial clinical experience with the new micro-stent showed a low rate of surgical complications with concomitant decreases in IOP and/or glaucoma medications.

Intrastromal corneal ring implantation for the correction of myopia: 12-month follow-up.

PURPOSE: To evaluate the efficacy, predictability, and stability of refraction obtained after intrastromal corneal ring segment (ICRS) implantation for low to moderate myopia. SETTING: Single-center clinical practice. METHODS: In this prospective 2-surgeon study, 9 patients (15 eyes) with low to moderate myopia were recruited to receive ICRS implants. RESULTS: At 1 day, 10 of the 15 eyes had an uncorrected visual acuity (UCVA) of 20/40 or better. At 12 months, all eyes had this UCVA and 66.6% had 20/25 or better. The mean manifest refraction stabilized after the first week at <-0.5 diopter (D). At 12 months, all eyes were within +/-1.0 D of the intended manifest refraction; 67% were within +/-0.5 D. Sixty percent of eyes had no change from the preoperative best corrected visual acuity; 13.3% improved by 1 line, and 26.6% lost 1 line. The postoperative complications included lamellar channel deposits (n = 12), ICRS dislocation (n = 2), corneal infiltrates (n = 2), bleeding in the positioning ring hole (n = 1), 0.3 mm segment decentration (n = 1), and prolonged wound healing (n = 1). CONCLUSIONS: Intrastromal corneal ring segment implantation for the correction of low to moderate myopia afforded good visual recovery and efficacy similar to that with laser in situ keratomileusis and superior to that with photorefractive keratectomy. However, light or blunt trauma and insufficient hygiene can have serious consequences and there is the potential for induced astigmatism. Corneal infiltrates can occur and must be treated immediately. The ring implantation technique is demanding. Advantages of ICRS implantation include rapid and stable visual recovery as well as reversibility.

[Initial results obtained with the multifocal lens MF4]. / Erste Ergebnisse der multifokalen Linse MF4.

BACKGROUND: Most patients depend on glasses for near vision after a cataract surgery with implantation of a monofocal IOL. Implantation of a multifocal IOL offers these patients the possibility to become independent of glasses. The aim of this study was to gain clinical experience with the multifocal MF4-Lens (IOLtech, France). PATIENTS AND METHODS: The MF4-lens was implanted in 80 eyes of 40 patients. Corrected and uncorrected near and far vision acuity were evaluated 3 months postop. Patients' satisfaction, the appearance of disturbing optical phenomena and the dependence on glasses were ascertained by means of an anonymous questionnaire. RESULTS: No surgical complications occurred in the course of this study. Three months after surgery, 92 % of all patients had an uncorrected visual acuity of 0.5 (20/40) or better. The binocular, uncorrected visual acuity was 0.63 (20/32) or better. The corrected far-vision acuity was 0.5 (20/40) or better. 86 % of all patients had an uncorrected near-vision acuity of 0.8 (20/25) and 45 % an uncorrected near-vision acuity of 1.0 (20/20). 94 % of the patients were satisfied with the results of the surgery. 38 % reported on glare and 45 % noticed halos. 67 % of all patients were totally independent of glasses, 27 % needed glasses frequently and 6 % generally. CONCLUSION: The implantation of the multifocal MF4-lens is an effective procedure in particular for near-vision acuity and patient satisfaction. The majority of patients were less dependent on glasses.