Juan F. Batlle

Three-Year Follow-up of a Novel Aqueous Humor MicroShunt.

Aims:An observational study to determine the safety and efficacy of filtering surgery employing a microlumen aqueous drainage device (InnFocus MicroShunt), used intraoperatively with Mitomycin C, implanted alone or in combination with phacoemulsification. Materials and Methods:Single-site, prospective, nonrandomized study of 23 eyes that had failed maximum tolerated glaucoma medication, followed for 3 years. A MicroShunt was implanted ab externo through a needle tract under the limbus, draining aqueous from the anterior chamber to the scleral surface. Prespecified outcome measures include: intraocular pressure (IOP) control, with and without supplemental medication, success rate, medication use, and adverse events. Results:Fourteen patients received the MicroShunt alone and 9 with cataract surgery. At 1 (n=23), 2 (n=22), and 3 (n=22) years of follow-up; the qualified success rate (IOP⩽14 mm Hg and IOP reduction ≥20%) was 100%, 91%, and 95%; mean medicated IOP was reduced from 23.8±5.3 to 10.7±2.8, 11.9±3.7, and 10.7±3.5 mm Hg, and the mean number of glaucoma medications/patient was reduced from 2.4±0.9 to 0.3±0.8, 0.4±1.0, and 0.7±1.1, respectively. The most common complications were transient hypotony (13%, 3/23) and transient choroidal effusion (8.7%, 2/23), all resolved spontaneously. There were no leaks, infections, migrations, erosions, persistent corneal edema, or serious long-term adverse events. Conclusion:Surgery with the InnFocus MicroShunt transscleral aqueous drainage tube with Mitomycin C achieved IOP control in the low teens in most subjects up to 3 years of follow-up with only transient adverse events occurring within the first 3 months after surgery.

The development of a micro-shunt made from poly(styrene-block-isobutylene-block-styrene) to treat glaucoma

Abstract Glaucoma is the second leading cause of blindness with ∼70 million people worldwide who are blind from this disease. The currently practiced trabeculectomy surgery, the gold standard treatment used to stop the progression of vision loss, is rather draconian, traumatic to the patient and requires much surgical skill to perform. This article summarizes the more than 10‐year development path of a novel device called the InnFocus MicroShunt®, which is a minimally invasive glaucoma drainage micro‐tube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenons Capsule. The safety and clinical performance of this device approaches that of trabeculectomy. The impetus to develop this device stemmed from the invention of a new biomaterial called poly(styrene‐block‐isobutylene‐block‐styrene), or “SIBS.” SIBS is ultra‐stable with virtually no foreign body reaction in the body, which manifests in the eye as clinically insignificant inflammation and capsule formation. The quest for an easier, safer, and more effective method of treating glaucoma led to the marriage of SIBS with this glaucoma drainage micro‐tube. This article summarizes the development of SIBS and the subsequent three iterations of design and four clinical trials that drove the one‐year qualified success rate of the device from 43% to 100%.

Candida Endophthalmitis After Descemet Stripping Automated Endothelial Keratoplasty With Grafts From Both Eyes of a Donor With Possible Systemic Candidiasis

Purpose: To report 2 cases with late postoperative Candida albicans interface keratitis and endophthalmitis after Descemet stripping automated endothelial keratoplasty (DSAEK) with corneal grafts originating from a single donor with a history of presumed pulmonary candidiasis. Methods: Two patients underwent uncomplicated DSAEK by 2 corneal surgeons at different surgery centers but with tissue from the same donor and were referred to the Bascom Palmer Eye Institute with multifocal infiltrates at the graft–host cornea interface 6 to 8 weeks later, and anterior chamber cultures that were positive for the same genetic strain of C. albicans. Immediate explantation of DSAEK lenticules and daily intracameral and instrastromal voriconazole and amphotericin injections failed to control the infection. Thus, both patients underwent therapeutic penetrating keratoplasty with intraocular lens explantation, pars plana vitrectomy, and serial postoperative intraocular antifungal injection. Results: Both patients are doing well at 2 years postoperatively with best-corrected vision of 20/20 and 20/30+ with rigid gas permeable lenses. One patient required repeat optical penetrating keratoplasty and glaucoma tube implantation 1 year after the original surgery. Literature review reveals that donor lenticule explantation and intraocular antifungals are often inadequate to control fungal interface keratitis, and a therapeutic graft is commonly needed. Conclusions: Interface fungal keratitis and endophthalmitis due to infected donor corneal tissue is difficult to treat, and both recipients of grafts originating from the same donor are at risk of developing this challenging condition.

The use of poly(styrene-block-isobutylene-block-styrene) as a microshunt to treat glaucoma

The InnFocus MicroShunt® is a minimally invasive glaucoma drainage microtube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenon’s capsule. The safety and clinical performance of this device approaches that of trabeculectomy with mitomycin C, the current ‘gold standard’ treatment for advanced glaucoma. The invention of a new biomaterial called poly(styrene-block-isobutylene-block-styrene) or ‘SIBS’ is the enabling factor which led to the success of this product. SIBS is ultrastable with virtually no foreign body reaction in the body, which manifests as clinically insignificant inflammation and capsule formation in the eye. The lack of capsule formation enables unobstructed flow through the 70 µm lumen tube and the achievement of controlled low intraocular pressure, which is important for the management of glaucoma. This article summarizes the integration of SIBS into a glaucoma drainage device and confirms its functionality with clinical success over a 2-year period.

Comparison of Low- and High-Volume Irrigation-Aspiration Systems for Extracapsular Cataract Extraction

A low-volume irrigation-aspiration system with a 1-mm tip (0.3-mm aspiration port) has been developed for extracapsular cataract extraction. This autoclavable system uses approximately 36% less irrigating fluid during the irrigation and aspiration of cortical material when compared to currently available models. The time required for cortical aspiration is also shortened by 33%. After three years of clinical experience with the low-volume system at the Miami Veterans Administration Medical Center, where almost all extracapsular cataract surgery is now performed with the new system, there have been no adverse effects and subsequent capsulotomy has rarely been necessary.

Comparison of phacoemulsification parameters between manual and femtosecond laser-assisted cataract surgery

OBJECTIVE To compare the nucleus removal time (NRT) and cumulative dissipated energy (CDE) outcomes of traditional phacoemulsification and femtosecond laser-assisted cataract surgery (FLACS) performed by cornea attendings and fellows. DESIGN Prospective nonrandomized comparative study. PARTICIPANTS A total of 410 eyes of 410 patients. METHODS Nucleus removal time and CDE were recorded from patients who underwent cataract surgery using either FLACS (Catalys, LenSx, or Victus) or traditional phacoemulsification technique performed by 3 cornea attendings and 4 cornea fellows. One-way analysis of variance with Bonferroni post hoc tests and unpaired t tests were used to determine the differences between groups. RESULTS There was no statistically significant difference in cataract grade between groups. NRT was significantly lower only when using the Catalys system compared with the LenSx and Victus platforms and the traditional surgery, in both the attending group (p = 0.006, p = 0.002, p < 0.000, respectively) and the fellow group (p = 0.049, p = 0.038, p = 0.011, respectively). With respect to CDE, there was no significant difference when using the laser systems compared with the traditional surgery in both attending and fellow groups (p > 0.05). NRT and CDE were significantly higher in the fellow group (NRT = 269.10 ± 117.67, CDE = 7.30 ± 4.83) compared with the attending group (NRT = 218.87 ± 109.67, CDE = 5.76 ± 3.66) in traditional cases; however, in FLACS cases, there was no significant difference in NRT and CDE between the fellow group and the attending group. CONCLUSIONS Inexperienced surgeons seem to require more time and use more ultrasound energy during traditional phacoemulsification when compared with experienced surgeons. The use of FLACS seems to significantly improve the NRT of experienced and inexperienced surgeons.

Association of Carotid-Cavernous Fistula with Central Retinal Vein Occlusion

576 Combined Central Retinal Vein Occlusion and Central Retinal Arterial Obstruction with Cilioretinal Artery Sparing A 37-year-old woman with stage IV chronic renal disease presented with shortness of breath 8 days after experiencing acute, painless vision loss in the right eye. Her systemic blood pressure was 209/122 mmHg. Vision examination revealed hand motion in the right eye and 20/15 in the left eye. Ophthalmoscopic examination of the right eye revealed extensive hemorrhages, cotton-wool spots, and ghost vessels with diffuse retinal edema and cilioretinal artery sparing (Fig 1A). The left fundus appeared normal. Fluorescein angiography (Fig 1B) showed retinal nonperfusion with cilioretinal artery sparing in early frames (Fig 1B, top), and leakage of the optic disc and peripheral retinal vessels in late frames (Fig 1B, bottom).

The Safety and Efficacy of Two-site Phacotrabeculectomy with Mitomycin C under Retrobulbar and Topical Anesthesia.

ABSTRACT Purpose: To evaluate and compare the safety and efficacy of combined two-site phacoemulsification and trabeculectomy surgery with mitomycin C (MMC) in glaucoma-cataract patients with retrobulbar or topical anesthesia. Patients and methods: A retrospective, nonrandomized review of consecutive phacotrabeculectomy patients with a minimum follow-up time of 6 months, no previous glaucoma surgeries, and a preoperative visual acuity (VA) greater than light perception. The main outcome measures were preoperative and postoperative VA, intraocular pressure (IOP), use of glaucoma medications, and complications. A complete surgical success required an IOP from 6 to 18 mm Hg, no visually devastating complications, no return to surgery, and no use of glaucoma medications. Qualified success allowed the use of up to two glaucoma medications. Anesthesia groups were compared by student t-tests and log rank comparison of Kaplan-Meier survival rates. Results: Eighty-seven eyes (83 patients) met inclusion criteria, with a mean follow-up of 19 ± 12 months (6-57 months). The average eye gained 3.1 ± 4.9 lines of VA, lost 4.0 ± 7.1 mm Hg of IOP, and decreased 1.0 ± 1.3 glaucoma medications. Retrobulbar and topical anesthesia groups had statistically equivalent mean changes in VA (p = 0.910), IOP (p = 0.268), and use of glaucoma medications (p = 0.964). Postoperative complication rates were also statistically similar (p = 0.580). Complete success was greater in the retrobulbar group (p = 0.006), however, qualified success was equivalent in both groups (p = 0.769). Conclusion: Two-site phacotrabeculectomy with MMC in West Indian patients is as safe and effective for glaucoma-cataract patients with topical anesthesia as it is under retrobulbar anesthesia, and without short-term losses in VA and the chance of serious complications from injection. How to cite this article: Rodriguez R, Alburquerque R, Sauer T, Batlle JF. The Safety and Efficacy of Two-site Phacotrabeculectomy with Mitomycin C under Retrobulbar and Topical Anesthesia. J Curr Glaucoma Pract 2016;10(1):7-12.