LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System.

PURPOSE: The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System. METHODS: LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were given multiwavelength PBM (590, 660, and 850 nm) or Sham treatment delivered in a series of nine sessions over 3 to 5 weeks every four months over 24 months. Subjects were assessed for efficacy and safety outcomes. Data from the 13-month analysis are presented in this report. RESULTS: A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy best-corrected visual acuity endpoint with a significant difference between PBM (n = 91 eyes) and Sham (n = 54 eyes) groups (Between group difference: 2.4 letters (SE 1.15), CI: -4.7 to -0.1, P = 0.02) (PBM alone: 5.4 letters (SE 0.96), CI: 3.5 to 7.3, P < 0.0001; Sham alone: 3.0 letters (SE 1.13), CI: 0.7-5.2, P < 0.0001). The PBM group showed a significant decrease in new onset geographic atrophy ( P = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed. CONCLUSION: LIGHTSITE III provides a prospective, randomized, controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM therapy.

Anatomic Biomarkers of Macular Edema Associated with Retinal Vein Occlusion.

PURPOSE: To assess the relationship between best-corrected visual acuity (BCVA) and anatomic features in patients with macular edema (ME) related to retinal vein occlusion (RVO). DESIGN: Post hoc analysis of 3 clinical trials, which included verified diagnoses, protocol refractions, and the assessment of OCT and fluorescein angiography (FA) images at a masked reading center. PARTICIPANTS: Patients diagnosed with RVO-ME. METHODS: Correlation analyses were performed to determine the correlation between BCVA and macular anatomy at baseline and at 12 and 24 weeks and between changes from baseline to 12 and 24 weeks. MAIN OUTCOME MEASURES: The correlations between BCVA and central subfield thickness (CST), ellipsoid zone (EZ) integrity, intraretinal fluid (IRF), subretinal fluid, central leakage, and ischemia were assessed. RESULTS: In a total of 828 eyes with RVO-ME, the mean age, BCVA, and CST at baseline was 64.7 years, 51.1 letters, and 656.9 µm, respectively. At baseline, a moderate negative correlation was observed between BCVA and CST (r = - 0.56, P < 0.001). At weeks 12 and 24, the mean BCVA of eyes with definitely abnormal (absent) EZ was statistically significantly worse than that of eyes with normal EZ. At week 12, a moderate negative correlation was observed between changes in BCVA and changes in CST (r = - 0.35, P < 0.001), with a similar degree of association noted at week 24 (r = - 0.35, P < 0.001). At weeks 12 and 24, eyes that showed any improvement in central IRF showed a greater improvement in BCVA than eyes that showed no improvement worsening (week 12: 463 eyes, 18.3 letters vs. 177 eyes, 13.0 letters, respectively, P < 0.001) and (week 24: 332 eyes, 20.2 letters vs. 131 eyes, 13.3 letters, respectively, P < 0.001). With respect to the correlation between baseline BCVA and fluorescein leakage or capillary nonperfusion, the Pearson correlation coefficients were - 0.41 (P < 0.001) and - 0.16 (P = 0.060), respectively. CONCLUSIONS: In addition to CST, there are important clinically relevant relationships between BCVA and both OCT and FA anatomic features in patients with RVO-ME.

Suprachoroidal CLS-TA plus Intravitreal Aflibercept for Diabetic Macular Edema: A Randomized, Double-Masked, Parallel-Design, Controlled Study.

PURPOSE: This study evaluated the potential safety, efficacy, and durability advantages of investigational triamcinolone acetonide suspension (CLS-TA; Clearside Biomedical, Alpharetta, GA) administered suprachoroidally in conjunction with intravitreal aflibercept compared with aflibercept monotherapy for treatment of diabetic macular edema (DME). DESIGN: TYBEE was a prospective, controlled, double-masked study. Patients were randomized 1:1 to CLS-TA and aflibercept (active) or aflibercept monotherapy (control), and assessed over 24 weeks. PARTICIPANTS: Treatment-naive DME patients with best-corrected visual acuity (BCVA) of 20 to 70 letters and central subfield retinal thickness (CST) of more than 300 µm. METHODS: Patients in the active group (n = 36) received CLS-TA and aflibercept at baseline and week 12. Patients in the control group (n = 35) received aflibercept at baseline, week 4, week 8, and week 12. To mask both groups, sham suprachoroidal and intravitreal injections were utilized. All patients were eligible to receive aflibercept as needed at weeks 4, 8, 16, and 20 per prespecified criteria. MAIN OUTCOME MEASURE: Mean change in BCVA from baseline. Treatment differences were assessed with a 2-sided significance level of 0.10. RESULTS: Mean BCVA changes from baseline to week 24 were not statistically different in the active and control groups (intention-to-treat [ITT] population: +11.4 letters and +13.8 letters [P = 0.288]; per protocol [PP] population: +12.3 letters and +13.5 letters [P = 0.664]; respectively). Greater improvement in CST was seen in the active versus control group (ITT population: -212.1 µm and -178.6 µm [P = 0.089]; PP population: -226.5 µm and -176.1 µm [P = 0.035]; respectively). Compared with the control group, eyes in the active group received fewer treatments (scheduled plus as-needed treatments averaging 4.6 versus 2.6, respectively). No treatment-related serious adverse events were observed. Ocular adverse events were low for both arms. Cataract events, all assessed as unrelated to treatment, and events of elevated intraocular pressure trended higher in the active group. CONCLUSIONS: CLS-TA administered suprachoroidally in conjunction with intravitreal aflibercept for treatment of DME provides simliar visual benefit at 24 weeks' follow-up compared with aflibercept monotherapy, is well tolerated and shows modest anatomic benefit with potential to reduce treatment burden.

Eustachian Tube Dysfunction in Children With Unilateral Cleft Lip and Palate: Differences Between Ipsilateral and Contralateral Ears.

OBJECTIVE: To evaluate Eustachian tube dysfunction in the ipsilateral and contralateral ears, in children with unilateral cleft lip and palate (UCLP). DESIGN: Retrospective chart review. SETTING: Tertiary care children's hospital. PATIENTS: Seventy-four consecutive patients with UCLP born between 2005 and 2011 and treated at UPMC Children's Hospital of Pittsburgh Cleft-Craniofacial Center were included. MAIN OUTCOME MEASURES: Conductive hearing loss, tympanogram type, number of middle ear effusions, tympanostomy tubes, and complications. Hypothesis was formulated prior to data collection. RESULTS: Conductive hearing loss was nearly twice as common in the ipsilateral ear (43.2%) compared with contralateral (23.0%; P = .001, McNemar test). There were no significant differences in the frequency of each type of tympanogram between the contralateral and ipsilateral ears. The proportions of ipsilateral (90.5%) and contralateral (91.9%) ears with effusion were not significantly different. The total number of tubes received was not significantly different between the 2 ears (median of 2 bilaterally). When combined, complications (retractions, perforations, and cholesteatomas) were significantly more common in the ipsilateral ear (29.7%) compared with the contralateral ear (18.9%; P = .039, McNemar test). CONCLUSION: In children with UCLP, there were significantly more instances of conductive hearing loss and complications on the cleft side compared to the noncleft side. This suggests that Eustachian tube dysfunction may indeed be more severe on the cleft side. Considering this information, clinicians may need to be especially observant of the ipsilateral ear.

Topical Squalamine 0.2% and Intravitreal Ranibizumab 0.5 mg as Combination Therapy for Macular Edema Due to Branch and Central Retinal Vein Occlusion: An Open-Label, Randomized Study.

BACKGROUND AND OBJECTIVE: To evaluate the effects of squalamine (OHR-102; Ohr Pharmaceuticals, New York, NY) and ranibizumab (Lucentis; Genentech, South San Francisco, CA) on macular edema (ME) secondary to retinal vein occlusion (RVO). PATIENTS AND METHODS: Twenty consecutive, treatment-naïve patients with RVO-related ME received topical squalamine and intravitreal ranibizumab 0.5 mg for 10 weeks, followed by randomization to continue or discontinue squalamine. Groups received as-needed ranibizumab from weeks 2 through 34. The primary endpoint was the proportion of eyes gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 38. Safety and tolerability were assessed. Data from 13 treatment-naïve control eyes previously enrolled in three similar trials evaluating monthly ranibizumab 0.5 mg for RVO-related ME were included for comparison. RESULTS: At baseline, mean best-corrected visual acuity (BCVA) measures were 55.6 ETDRS letters and 55.0 ETDRS letters in the squalamine and control groups, respectively. At week 38, BCVA improved 25.6 letters in the squalamine group; at month 9, BCVA improved 16.3 letters in the control group. This corresponds to a between-treatment-group difference of 9.2 letters. Squalamine and ranibizumab combination therapy was well-tolerated. CONCLUSIONS: In patients with RVO-related ME, topical squalamine combined with early, as-needed ranibizumab appears to enhance visual recovery versus ranibizumab alone. Combination therapy appears safe and was well-tolerated. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:914-923.].

Removal of posterior segment retained lens material using the OZil phacoemulsification handpiece versus Fragmatome during pars plana vitrectomy.

PURPOSE: To assess the utility of the torsional phacoemulsification handpiece compared to the Fragmatome during pars plana vitrectomy for removal of posterior segment retained lens material. DESIGN: : Retrospective comparative case series. METHODS: Thirty-four eyes of 34 patients at 2 centers who underwent pars plana vitrectomy for retained lens material with either torsional phacoemulsification or the Fragmatome were retrospectively reviewed. Lens material was graded by nuclear density and percentage of total nuclear size. The primary outcome measure was mean change in visual acuity. Secondary outcomes included intraoperative or postoperative complications, occurrence of mechanical malfunctions and metric data including the total ultrasound, phacoemulsification, and torsional times. RESULTS: In the torsional ultrasound group (17 eyes), mean nuclear density was 3.6 and mean size was 63%. Mean initial logarithm of minimum angle of resolution visual acuity was 1.58 (20/760) and improved to 0.66 (20/80) at postoperative Month 3, a gain of 0.92 (P = 0.003). One eye developed a self-limited, peripheral, serous, choroidal detachment intraoperatively, whereas two eyes developed postoperative cystoid macular edema. Mean total ultrasound, phacoemulsification, and torsional times were 76.7, 13.4, and 63.3 seconds, respectively. Mean total operative time to remove retained lens material (excluding vitreous gel removal) was 111 seconds. All the patients demonstrated excellent followability based on independent observations by the surgeons. In the Fragmatome group (17 eyes), initial logarithm of minimum angle of resolution visual acuity was 1.51 (20/640) and improved to 0.6 (20/80) at postoperative Month 3, a gain of 0.91 (P < 0.001). One eye developed a retinal detachment at postoperative Week 2, whereas 3 eyes developed postoperative cystoid macular edema. CONCLUSION: The use of torsional phacoemulsification during pars plana vitrectomy for retained lens material is a novel approach with potential advantages over the standard 20-gauge Fragmatome, including improved followability and purchase of lens material attributable to the addition of torsional movement.

Endophthalmitis in microincision vitrectomy: outcomes of gas-filled eyes.

PURPOSE: To assess whether performing an air or gas exchange at the conclusion of a microincision vitrectomy procedure is beneficial regarding the rate of endophthalmitis. METHODS: This was a collaborative, multicenter, retrospective chart review of 2,336 eyes that underwent microincision sutureless vitrectomy (23 or 25 gauge) with either SF6 or C3F8 gas endotamponade for macular hole between January 2008 and December 2009. For all eyes, the search methodology was structured to identify the main outcome measure, which was the occurrence of acute postoperative endophthalmitis (<6 weeks after pars plana vitrectomy). RESULTS: Of the cumulative 2,336 consecutive cases over a 2-year period, only 1 (0.04%) had postoperative endophthalmitis. All eyes had near-complete gas-fluid exchange at the end of surgery; C3F8 was the most common endotamponade agent. The majority of cases were performed with 23-gauge vitrectomy. No other complications were noted. CONCLUSION: Endophthalmitis was a rare occurrence in this large series of gas-filled eyes after macular hole surgery (0.04%). Gas endotamponade after microincision sutureless vitrectomy may be beneficial in reducing the risk of postoperative endophthalmitis; however, additional studies are necessary to make a definitive recommendation.

A pilot study of normative data for macular thickness and volume measurements using cirrus high-definition optical coherence tomography.

PURPOSE: To establish preliminary normative data for macular thickness (MT) and macular volume (MV) by Cirrus high-definition optical coherence tomography (Carl Zeiss Meditec, Dublin, CA). METHODS: Retrospective case series of 192 eyes of 192 subjects (age, 20-90 years) without retinal disease or surgery with best-corrected visual acuity ≥ 20/25, intraocular pressure <21 mmHg, and cup-to-disc ratio ≤ 0.5 were enrolled. Retinal thicknesses in nine Early Treatment Diabetic Retinopathy Study subfields (including central subfield thickness [CST]), MT, and MV were measured with Cirrus high-definition optical coherence tomography. Effects of age, gender, lens status, and diabetic status on these measurements were analyzed. RESULTS: The mean ± SD CST, MT, and MV were 262.4 ± 22.8 µm, 281.3 ± 14.5 µm, and 10.1 ± 0.6 mm3, respectively. Although CST and age were not associated (P = 0.45), both mean MT and mean MV declined with age (P < 0.0001). Central subfield thickness (P = 0.002), mean MT (P = 0.021), and MV (P = 0.041) were higher in men compared with women. Neither lens status nor diabetic status affected CST, MT, or MV. CONCLUSION: A pilot study showed that preliminary normative CST, MT, and MV values were obtained by Cirrus high-definition optical coherence tomography. The authors propose that CST ranges from 216.8 µm to 308 µm in normal eyes. Older age and female gender were associated with thinner MT.

Pupillary Block Glaucoma After Pars Plana Vitrectomy with Air-Fluid Exchange in Pseudophakic Air-Filled Eye.

Pupillary block is seen after pars plana vitrectomy (PPV) with gas or silicone oil endotamponade in aphakic eyes. A case of a pseudophakic patient with pupillary block glaucoma related to the migration of air into the anterior chamber was reported. A 76-year-old woman underwent combined PPV with air endotamponade and uncomplicated cataract extraction for epiretinal membrane and cataract. On postoperative day 1, she had an 80% air fill of the anterior chamber. She returned 6 days later with pupillary block glaucoma. She was managed with a surgical peripheral iridectomy, posterior synechiolysis, and evacuation of the air from the anterior chamber. The risk of pseudophakic pupillary block glaucoma after PPV with air tamponade may be increased with inflammation due to combined PPV and cataract extraction, zonular weakness, and efflux of air from the vitreous cavity into the anterior chamber. Early detection and treatment is recommended to avoid permanent sequelae.

Using a composite material containing waste tire powder and polypropylene fiber cut end to recover spilled oil.

The superior oil absorption capacity of recycled polypropylene (PP) fiber and waste tire powder were used to recover spilled engine oil. We used ASTM F726-99 method to evaluate oil adsorbing capability of PP fiber and found it to have a large, rapid oil sorption capacity. However, its lack of elasticity dramatically limited that capacity after repeated use. Tire powder, which absorbs less oil more slowly, is more elastic than PP fiber and can be used repeatedly up to a hundred times without losing its oil adsorption capability. We combined PP fiber and tire powder to develop a composite material capable of recovering greater amounts of oil than any of its components. This composite can be use repeatedly for at least 100 times. Thus, the material cost for recovering 1 ton of spilled oil is about USD $0.03, making it very competitive on the market.

Endophthalmitis after pars plana vitrectomy a 20- and 25-gauge comparison.

OBJECTIVE: Recent retrospective analyses have suggested that postoperative endophthalmitis may be more frequent with 25- than 20-gauge pars plana vitrectomy (PPV). Because the infection risk may depend on the suturing status of the sclerotomy, and the perioperative anti-infection protocol, we compared the incidence rate of endophthalmitis after sutureless 25-gauge versus sutured 20-gauge PPV on a large cohort of patients operated with a standardized perioperative anti-infection protocol. DESIGN: Retrospective comparative case series. PARTICIPANTS: Consecutive patients who underwent 20- or 25-gauge PPVs at a single center over a multi-year period. METHODS: We analyzed 3597 consecutive PPVs. Patients with a pre-PPV diagnosis of endophthalmitis, PPVs performed for implantation of drug delivery devices, or 25-gauge PPVs with all sclerotomies sutured closed were excluded. Patients with > or =1 week of follow-up were divided into 2 study groups by sclerotomy status at the end of surgery: the 20-gauge group had 3 sutured 20-gauge sclerotomies, and the 25-gauge group had > or =1 unsutured 25-gauge sclerotomy. Endophthalmitis was defined by clinical criteria independent of microbiological results. MAIN OUTCOME MEASURES: The incidence of endophthalmitis was compared between 25- versus 20-gauge groups. RESULTS: Of 3372 PPV surgeries meeting inclusion and exclusion criteria, 1948 and 1424 surgeries were 20- and 25-gauge PPVs, respectively. Average age (+/- standard deviation) of patients was 54.6 (+/- 22.6) and 64.4 (+/- 16.5) years in the 20- and 25-gauge PPV groups, respectively (P<0.0001). Median post-PPV follow-up time was not significantly different between the 2 groups (12.5 vs 13.0 months; P = 0.69). Endophthalmitis was observed in 1 patient (0.07%; 95% confidence interval, 0%-0.21%) from the 25-gauge group and none in the 20-gauge group (P = 0.42; Fisher exact test, 2-tailed). The use of air/gas endotamponade (P<0.0001) and intravitreal triamcinolone (P<0.001) was more common in 25- versus 20-gauge PPV. CONCLUSIONS: The incidence of endophthalmitis was low in both groups. We were unable to show a significant difference in the incidence of endophthalmitis between sutureless 25-gauge and sutured 20-gauge PPV, and conclude that a careful perioperative anti-infection protocol may reduce 25-gauge PPV endophthalmitis risk to that of 20-gauge PPV.

Ultra Wide Field Fluorescein Angiography Guided Targeted Retinal Photocoagulation (TRP).

We report two cases in which ultra wide field fluorescein angiography was used to direct targeted retinal photocoagulation (TRP) to areas of retinal capillary non-perfusion in an attempt to cause regression of diabetic neovascularization. By providing up to a 200 degree field of view, accurate delineation of retinal capillary non-perfusion and precise application of photocoagulation was possible. The application of TRP successfully led to the regression of the retinal neovascularization in our patients. Complications of conventional panretinal photocoagulation (PRP) such as visual field loss and macular edema may have been avoided. When TRP is used in conjunction with ultra wide field fluorescein angiography, preservation of functional retina may be possible while minimizing the amount of laser treatment that is applied to the retina.