The impact of vitrectomy on outcomes achieved with 0.19 mg fluocinolone acetonide implant in patients with diabetic macular edema.

BACKGROUND: There is a lack of consensus on the use of intravitreal corticosteroid therapies in patients with diabetic macular edema (DME) and prior vitrectomized eyes in clinical practice. METHODS: Retro-IDEAL was a 3-year retrospective, multicenter study in patients with chronic DME (i.e. DME that persists or recurs despite treatment) treated with ILUVIEN® (0.2 µg daily fluocinolone acetonide intravitreal implant), who had suboptimal outcomes with first-line vascular endothelial growth-factor inhibitors and other DME therapies. RESULTS: A total of 81 eyes (63 patients) were included of which 39 eyes had undergone prior vitrectomy (PV group) while 42 eyes had not undergone prior vitrectomy (NPV). Baseline characteristics were balanced; however, more patients had proliferative diabetic retinopathy in the PV group vs. the NPV group (21.62% vs 9.38%, respectively). Over 36 months, mean visual acuity (VA) increased in both groups with a tendency for more ETDRS letters being gained in the NPV group (+5.33) vs. the PV group (+2.42). By month 36, central retinal thickness was reduced to ⩽300 µm in two-thirds of the eyes in both groups and the mean change from baseline in intraocular pressure was similar in both groups (+0.50 mmHg -0.75 mmHg; NPV and PV group). CONCLUSIONS: These long-term data suggest that the 0.2 µg/day FAc implant is effective in both vitrectomized and non-vitrectomized patients, with a manageable safety profile, and improved VA and reduced supplemental therapies for patients with a suboptimal response to first-line DME therapies. Clinicians may consider utilizing the FAc implant earlier in the DME disease process.

[Monocentric, Retrospective, Comparative Study of the Safety and Effectiveness of Wound Modulation with Bevacizumab after Combined Cataract Surgery with Implantation of the CyPass Stent]. / Monozentrische, retrospektive, vergleichende Studie zur Sicherheit und Effektivität der Wundheilungsmodulation mit Bevacizumab nach kombinierter Kataraktoperation mit CyPass-Stent-Implantation.

BACKGROUND: Because of the known positive effect of bevacizumab (Avastin®) on wound modulation in trabeculectomy, a retrospective study evaluated the safety and efficacy of wound modulation with Avastin following combined cataract surgery with CyPass stent. METHOD: Retrospectively, the pre-, intra- and postoperative data (after three and six months) were collected from 484 eyes after combined surgery (n = 187 without Avastin, n = 297 with Avastin). The safety criteria were intraoperative complications and postoperative slit-lamp microscopic findings. Efficacy criteria were intraocular pressure (IOP) and number of IOP-lowering drugs. RESULTS: With respect to age and sex distribution, early postoperative fibrin reaction, intraocular pressure and reduction in medication, the two groups (with and without Avastin) did not differ statistically significantly. However, iris tissue reactions were statistically significantly more frequently observed three months postoperatively in the control group than in the Avastin group (chi square test: p = 0.02, n = 47/128); there is a slight trend after six months towards less iris tissue reaction in the Avastin group (chi square test: p = 0.15, n = 45/125). Other trends in favour of the Avastin group were identified within the failure rate (2% compared to 6% at three months (chi square test: p = 0.103, n = 50/130) and 4 to 10% at six months (chi square test: p = 0.106, n = 50/130) and within the proportion of eyes without supplemental hypotensive medication, with 86 vs. 74% and 68 vs. 56% (chi square test: three months: p = 0.053; six months: p = 0.12; n = 50/130). In addition, 85% of the eyes in the Avastin group reached the postoperative pressure threshold of ≤ 21 mmHg without supplemental hypotensive medication three months postoperatively and 65% after six months compared to 74% (chi square test: p = 0.099, n = 50/130) and 54% (chi square test: p = 0.11, n = 50/130) in the control group. CONCLUSION: The postoperative injection of Avastin into the anterior chamber is safe, reduces iris tissue reactions and improves efficacy up to six months postoperatively to a clinically limited extent.

Supraciliary Microstent in Refractory Open-Angle Glaucoma: Two-Year Outcomes from the DUETTE Trial.

PURPOSE: The aim of the study was to report longer term (24-month) outcomes for primary open-angle glaucoma (POAG) patients refractory to medical therapy implanted with a supraciliary microstent (CyPass Micro-Stent, Alcon) in the DUETTE clinical study. METHODS: Sixty-five eyes were enrolled in this multicenter single-arm trial. Enrolled patients had POAG and intraocular pressure (IOP) >21 mmHg at baseline on 1-4 ocular hypotensive medications. Microstent implantation was performed as stand-alone surgery in these phakic or pseudophakic patients through a standard clear corneal approach. IOP and the use of IOP-lowering medications were monitored in this 1-year extension beyond the 12-month primary endpoint. RESULTS: Two-year follow-up visits were scheduled to confirm the 12-month results; safety data were obtained for 37 eyes of 35 patients. IOP at the end of the 24-month follow-up was 16.8 mmHg (n = 32), with a mean reduction of 7.7 mmHg from the baseline IOP of 24.5 mmHg (n = 65). Medication use was decreased from an average of 2.1 (baseline) to 1.5 at 24 months. The IOP and medication use at 24 months were consistent with the 12-month results (16.4 mmHg, 1.4 medications) reported previously. The adverse event profile remained as described for the first 12 months postimplantation. CONCLUSIONS: Placement of a supraciliary microstent provides up to 24 months of effective IOP lowering for medication-refractory POAG patients while, on average, decreasing the requirement for ocular hypotensive medications.

[Healthcare Research of Cataract Surgery - Analysis of Patient's Satisfaction Following Cataract Surgery in Mecklenburg-Vorpommern/Germany]. / Versorgungsforschung in der Kataraktchirurgie ­ eine Analyse der Patientenzufriedenheit nach Kataraktchirurgie in Mecklenburg-Vorpommern.

Background The collection of pre-, peri- and postoperative data took place between 2005 and 2008, based on a contract between the social insurance company, AOK Mecklenburg-Vorpommern, and the outpatient cataract surgeons/centers in Mecklenburg-Vorpommern, Germany. The purpose of the contract was the monitoring of quality of cataract surgery in the outpatient healthcare system. Materials and Methods We analysed 2952 datasets of 2952 eyes, remaining after exclusion of 109 datasets because of lack of plausibility and missing data (initially 3058 eyes with surgery in our centre). Visual acuity (VA), refraction, comorbidities and further data were correlated to patient satisfaction with cataract surgery. Results The average age of our patients was 74.5 years (Cataracta senilis 96.51%) and they had a mean VA increase from decimal 0.4 ± 0.2 (LogMAR 0.5 ± 0.3) to 0.8 ± 0.3 (LogMAR 0.2 ± 0.2). The target refraction was reached by 78.9% (respectively 49.9%) of the eyes within ± 1.0 D (respectively ± 0.5 D). Factors correlating with a positive overall satisfaction of the patients with surgery were the postoperative increase of VA (Spearman, r = 0.404, p = 0.01), the absence of comorbidities (Spearman, r = - 0.168, p = 0.01) and absence of perioperative complications (Spearman, r = - 0.104, p = 0.01). 1.7% of our patients were dissatisfied despite an increase of VA ≥ 0.1, no comorbidities and no complications. We found the biggest percentage of not satisfied patients without objective reason (Patient-reported Outcome Measure negative/Clinical Outcome Measure positive, PROM-/COM+ 3.9%) in the sector of improvement of reading abilities. Conclusion With a not preselected patient cohort, we reached internationally comparable visual, refractive and satisfaction results. The overall satisfaction with cataract surgery is high. The majority of our patients (84.2%) were PROM+ combined with COM+ (VA increase ≥ 0.1). Dissatisfaction could be explained by the presence of comorbidities, perioperative complications and with a poor surgical outcome (no increase of VA ≥ 0.1). Nevertheless 1.7% of our patients remained unsatisfied without an objective reason (COM+, PROM-), which underlines the importance of general life satisfaction.

Experimental and Numerical Determination of the Local Temperature Distribution during Phacoemulsification and Comparison of Different Surgery Situations within Enucleated Porcine Eyes.

Phacoemulsification, a common treatment for cataract, is accompanied by cell damage at the corneal endothelium. Thermal exposure during treatment has been considered a reason for this damage, but a thorough experimental and theoretical assessment of the local temperature distribution inside the eye had not yet been conducted. Measurements in porcine eyes and a finite-element simulation enabled such an assessment and localized the highest temperature rise very close to the probe. The results described in this study indicate that a distance of 1 mm between the probe and the endothelium should be maintained during treatment as a safety margin, especially when fluid flow is blocked. The highest measured temperature rise with surgically reasonable system settings and unblocked fluid flow was 1.11°C. The finite-element simulation described here is able to calculate the temperature rise at the endothelium and could serve as a tool for comparing arbitrary surgical situations with respect to thermal exposure of the endothelium.

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.

Computation of the temperature rise at the corneal endothelium during cataract surgery by modeling of heat generation inside the anterior chamber.

The corneal endothelium sustaining the transparency of the cornea is a vulnerable cell layer. Thermal exposure during phacoemulsification is considered to be a potential cause of post-operative cell loss. Knowledge of the temperature rise and particularly of its dependence on region and system settings could deliver useful information about a potential correlation with cell damage. However, there exists a lack of understanding of the process and location of heat generation. Analytical calculations and experiments enabled the quantification of different mechanisms acting as heat sources during phacoemulsification. Heat generation caused by viscous friction was estimated using both an analytical approach and a numerical simulation. In contrast to absorption of sound and self-heating of the probe, this effect was ascertained to be the main heat source. Calorimetric measurement of the power input verified this modeling. On the basis of these results, the local temperature distribution inside a porcine eye was computed time dependently using the finite-element method. Two different amplitude settings were compared with respect to the temperature increase at the corneal endothelium. Various conclusions on the mitigation of thermal exposure during treatment can be drawn from this finite-element simulation.

[Intracorneal ring segments for the correction of myopia--suggestions to ensure a high standard of quality]. / Der intrakorneale Ring zur Myopiekorrektur - Vorschläge zur Qualitätssicherung.

INTRODUCTION: The implantation of intracorneal ring segments (ICR-S) is the first reversible refractive surgical technique for the correction of low myopia. It is an effective and safe technique with a low rate of complications. Despite numerous publications it is a relatively new technique and its long-term tolerance cannot yet be assessed. Hence, it is recommendable to examine operated patients according to a standardised protocol for a longer period of time postoperatively. In this paper we present appropriate documentation forms. MATERIAL AND METHODS: Based on experience gained in more than 100 ring implantations and a follow-up of three years, suggestions for follow-up dates and methods were developed. RESULTS: Follow-up dates are recommended before surgery, on the day of surgery, on the 1 st postoperative day, after the first postoperative week and the first, third, sixth and twelfth postoperative months and thereafter annually. The examination methods are listed in nine different documentation forms adapted to each follow-up date. In the Ophthalmological Department of the Clinic of Neubrandenburg, Germany, anonymous data are recorded by electronic data processing continuously and analyzed every three months. This guarantees to continually ensure the standard of quality. Other centres implanting intracorneal ring segments are welcome to make use of this system. SUMMARY: The documentation forms are a suggestion for standardisation of the follow-up after implantation of intracorneal ring segments. The adaptation of the forms to the further development is necessary and planned. It allows a comparison and early feedback on own results and is a contribution to long-term observation and to ensure a high standard of quality in a patient-oriented standard of care.