Mark R. Wieland

Perfluorocarbon liquid in the management of retinal detachment with proliferative vitreoretinopathy.

PURPOSE To describe the techniques and results of perfluoro-N-octane used during vitrectomy for managing retinal detachment with severe proliferative vitreoretinopathy (PVR). METHODS The authors retrospectively studied 223 consecutive patients who underwent vitreoretinal surgery for severe PVR (93% D1-D3). Patients underwent an average of 1.72 prior vitreoretinal surgeries. Perfluoro-N-octane was used intraoperatively to flatten the retina, avoiding posterior drainage retinotomy, to identify areas of residual retinal traction and periretinal membranes, to stabilize the peripheral retina during dissection of anterior PVR, and to help determine the extent and location of relaxing retinotomies. Extended-term gas tamponade was used in 91% of eyes. All patients were followed for a minimum of 6 months. RESULTS Seventy-eight percent of the retinas were reattached posterior to the scleral buckle after a single vitreoretinal surgery and 96% were reattached after multiple surgeries. An average of 1.24 vitrectomy surgeries were required. The final visual acuity was 20/400 or better in 74% of eyes and 20/80 or better in 30% (P = 0.004). Preoperative hypotony (intraocular pressure < or = 5 mmHg) and multiple prior vitreoretinal surgeries were associated with a poor final visual acuity (P = 0.01 and 0.02, respectively). Preoperative hypotony (intraocular pressure < or = 5 mmHg) was associated with a greater frequency of relaxing retinotomies (P = 0.02). Retained perfluoro-N-octane was observed postoperatively in the vitreous cavity in 1.3% and subretinal perfluoro-N-octane in 0.9%. CONCLUSION Experience with perfluoro-N-octane has demonstrated its usefulness both diagnostically and therapeutically as an intraoperative tool and improved the anatomic and visual outcome for retinal detachment complicated by severe PVR.

Influence of Glycosylated Hemoglobin on the Efficacy of Ranibizumab for Diabetic Macular Edema: A Post Hoc Analysis of the RIDE/RISE Trials

PURPOSE To investigate the influence of glycosylated hemoglobin (HbA1c) on treatment outcomes in patients with diabetic macular edema (DME) receiving intravitreal ranibizumab. DESIGN Post hoc analysis of 2 identical phase III clinical trials assessing the efficacy and safety of intravitreal ranibizumab in DME over 36 months (RIDE: NCT00473382/RISE: NCT00473330). PARTICIPANTS A total of 483 adults with vision loss from DME treated with ranibizumab were included in this analysis from RIDE/RISE. Participants received monthly intravitreal ranibizumab (0.3 or 0.5 mg). MAIN OUTCOME MEASURES Differences in visual and anatomic outcomes, and diabetic retinopathy (DR) severity score, between subgroups of patients with baseline HbA1c ≤7% versus HbA1c >7% at 36 months. RESULTS There were 195 patients in RIDE/RISE who were treated with ranibizumab with a baseline HbA1c ≤7% and 288 patients with a baseline HbA1c >7% included in this analysis. The mean improvement in visual acuity (VA) at 36 months was +13 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with baseline HbA1c ≤7% compared with +11 ETDRS letters in the patients with a baseline HbA1c >7% (P = 0.17). After adjustment for baseline central foveal thickness (CFT) and duration of diabetes, the mean CFT reduction was -268 μm in patients with a baseline HbA1c ≤7% and -269 μm in patients with a baseline HbA1c >7% (P = 0.98; 95% confidence interval, -22.93 to 23.54). The proportion of patients with a ≥2-step improvement in DR severity score was 38% in patients with baseline HbA1c ≤7% compared with 41% in the patients with a baseline HbA1c >7% (P = 0.53). There was no correlation of baseline HbA1c with any visual or anatomic parameter. CONCLUSIONS The improvement in VA, anatomic reduction of macular edema, and improvement in DR severity score with ranibizumab treatment seem to be independent of baseline HbA1c.

Sustained-release intravitreal liquid drug delivery using triamcinolone acetonide for cystoid macular edema in retinal vein occlusion.

PURPOSE To investigate side effects seen with this formulation and to search for evidence of effectiveness after a single intravitreal injection of IBI-20089 in eyes with cystoid macular edema (CME) secondary to retinal vein occlusion. DESIGN Prospective, phase 1 clinical trial. PARTICIPANTS Ten patients with chronic CME resulting from retinal vein occlusion. METHODS Patients received a single intravitreal injection of IBI-20089 using a sequential dose escalation schedule. Each cohort consisted of 5 patients who received the intravitreal injection of the sustained liquid drug delivery system containing either 6.9 mg (25 μl) triamcinolone acetonide (TA; cohort 1) or 13.8 mg (50 μl) TA (cohort 2). At each study visit, best-corrected visual acuity testing, slit-lamp biomicroscopy, IOP measurement, dilated ophthalmoscopy, fundus photography and optical coherence tomography (OCT) were performed. Patients also underwent laboratory testing and physical examinations to monitor for any systemic adverse events. MAIN OUTCOME MEASURES Optical coherence tomography central subfield thickness, ocular and systemic adverse events. RESULTS In cohort 1, mean baseline OCT central subfield thickness (CST) was 477 μm and decreased to 369 μm at day 1 (P<0.06), 387 μm at day 30 (P = 0.18), and 251 μm at day 360 (P = 0.46). In cohort 2, mean baseline OCT CST was 518 μm and decreased to 404 μm at day 1 (P = 0.134), 289 μm at day 30 (P = 0.003), 207 μm at day180 (P = 0.004), and 278 μm at day 360 (P = 0.009). Related adverse events included elevation of IOP in 3 patients, in 2 because of neovascular glaucoma (not related to study drug) and in 1 who required a glaucoma tube shunt. CONCLUSIONS A single intravitreal injection of IBI-20089 resulted in a controlled and sustained delivery of a TA. Side effects included elevated IOP in 3 eyes, 2 of which had neovascular glaucoma.

PROSPECTIVE EVALUATION OF A SUSTAINED-RELEASE DEXAMETHASONE INTRAVITREAL IMPLANT FOR CYSTOID MACULAR EDEMA IN QUIESCENT UVEITIS.

Purpose: To investigate dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc) in the treatment of uveitic cystoid macular edema that had persisted in the absence of intraocular inflammation. Methods: In this prospective interventional case series, 10 patients with uveitic cystoid macular edema and quiescent uveitis were treated with dexamethasone intravitreal implant at baseline and evaluated monthly for one year. Patients were retreated whenever cystoid macular edema recurred. The primary outcome measure was best-corrected visual acuity (BCVA) at day 90. Results: At day 90, mean improvement from baseline BCVA was 14.4 letters (P = 0.0003), 70% of patients had a ≥10 letter BCVA improvement, 50% of patients had a ≥15 letter BCVA improvement, and the mean decrease from baseline central subfield retinal thickness was 140 &mgr;m (P = 0.008). Improvements were maintained through day 360 with retreatment as needed. At day 360, mean improvement in BCVA was 16.5 letters (P = 0.006) and the mean decrease in central subfield retinal thickness was 158 &mgr;m (P = 0.002). One patient experienced intraocular pressure >25 mmHg (managed with topical medication). Two phakic patients (2/8; 25%) had worsening of lens opacity requiring cataract extraction. Conclusion: Dexamethasone intravitreal implant may be an effective treatment for patients with persistent cystoid macular edema in quiescent uveitis.

A Chemical Heat Pack-Based Method For Consistent Heating of Intravenous Fluids

BACKGROUND Transfusion of cold intravenous fluids (IVF) can exacerbate hypothermia. Civilian and military guidelines recommend heated IVF for hypothermic patients; however, there is currently no ideal IVF heating system for use in resource-limited settings. OBJECTIVE Development of a system that uses flameless ration heaters (FRH) and an insulated sleeve for the consistent delivery of IVF at physiologically appropriate temperatures (40°-42°C) over the range of ambient conditions typical of the prehospital and wilderness environments. METHODS The temperatures of 0.9% normal saline (NS) 1-L bags were measured under 3 ambient conditions: 3°C, 10°C, and 20°C. The IVF was placed in an insulated pouch along with a predetermined number of activated FRH (5 FRH for 3°C, 4 FRH for 10°C, and 3 FRH for 20°C) for 10 minutes before removing the FRHs. The insulated IVF bag was drained through 280 cm of intravenous tubing at a flow rate of 77 mL/min. Raw temperature data for internal and delivery temperatures were collected and analyzed. RESULTS The temperature of the IVF throughout the delivery of 1 L of NS under the 3 ambient conditions was as follows (mean ± SD): at 3°C ambient, 47° ± 2.1°C internal and 42.6°C ± 1.4°C at delivery; at 10°C ambient, 52.3° ± 2.7°C and 45.2° ± 1.6°C; and at 20°C ambient, 45.5° ± 1°C and 39.7° ± 0.7°C. CONCLUSIONS The IVF heating system described here reliably delivered physiologically appropriate temperature intravenous fluids in 2 of the 3 ambient treatment conditions. With the appropriate number of FRH for the ambient conditions, this system enables the delivery of warmed IVF to provide active warming, which may be clinically beneficial in the prevention and treatment of hypothermia.