A Randomized, Controlled Comparison of NCX 470 (0.021%, 0.042%, and 0.065%) and Latanoprost 0.005% in Patients With Open-angle Glaucoma or Ocular Hypertension: The Dolomites Study.

PRCIS: NCX 470 0.042% and 0.065% were statistically superior in intraocular pressure (IOP) lowering to latanoprost 0.005%, and NCX 470 0.021% was noninferior. All NCX 470 concentrations were safe and well tolerated. PURPOSE: The purpose of this study was to compare varying concentrations of NCX 470 (a nitric oxide-donating bimatoprost) to latanoprost in a dose-response safety and efficacy trial. PATIENTS AND METHODS: Adult patients with bilateral open-angle glaucoma or ocular hypertension were randomized to NCX 470 0.021% (n=111), 0.042% (n=108), 0.065% (n=107), or latanoprost 0.005% (n=107) once daily in the evening. IOP was measured at 8:00 am, 10:00 am, and 4:00 pm at weeks 1, 2, and 4. The primary efficacy endpoint was the reduction from baseline in mean diurnal IOP at week 4. Secondary efficacy endpoints included reductions from baseline in mean diurnal IOP at weeks 1 and 2, and reductions from baseline in time-matched IOP at 8:00 am, 10:00 am, and 4:00 pm at weeks 1, 2, and 4. Adverse events were evaluated. RESULTS: All concentrations of NCX 470 resulted in significant reductions of mean diurnal IOP. The 0.042% and 0.065% concentrations were statistically superior to latanoprost 0.005%, and 0.021% was noninferior to latanoprost for change from baseline in mean diurnal IOP at week 4. The 0.065% concentration was also superior to latanoprost by up to 1.4 mm Hg for reduction from baseline at 8:00 am, 10:00 am, and 4:00 pm at week 4. NCX 470 was safe and well tolerated; conjunctival hyperemia was the most frequently reported adverse event. CONCLUSIONS: NCX 470 demonstrated dose-dependent reductions in IOP. The 0.042% and 0.065% concentrations demonstrated significantly greater reductions from baseline in mean diurnal IOP than latanoprost 0.005% at week 4, suggesting that higher concentrations may show even greater efficacy.

Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients With Open-angle Glaucoma or Ocular Hypertension.

PRECIS: In pooled phase III analyses, once-daily netarsudil 0.02% resulted in intraocular pressure (IOP) reduction that was noninferior to twice-daily timolol 0.5%, with minimal treatment-related serious or systemic adverse events (AEs). Ocular AEs were generally tolerable. PURPOSE: The purpose of this study was to assess the efficacy and safety of the Rho kinase inhibitor netarsudil in patients with open-angle glaucoma or ocular hypertension. PATIENTS AND METHODS: Pooled analysis of data from the ROCKET-1 to 4 phase III studies of once-daily (PM) netarsudil or twice-daily timolol in patients with open-angle glaucoma or ocular hypertension. The primary efficacy measure was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3 in patients with baseline IOP <25 mm Hg. RESULTS: In the pooled primary efficacy population (netarsudil, n=494; timolol, n=510), once-daily netarsudil was noninferior to twice-daily timolol at all 9 timepoints through month 3. Mean treated IOP ranged from 16.4 to 18.1 mm Hg among netarsudil-treated patients and 16.8 to 17.6 mm Hg among timolol-treated patients. In the pooled safety population (n=839 in each treatment group), treatment-related serious AEs occurred at similar frequencies in each treatment group (netarsudil, 0.1%; timolol, 0%). The most common ocular AE, conjunctival hyperemia (netarsudil, 54.4%; timolol, 10.4%), was graded as mild in 77.6% (354/456) of affected netarsudil-treated patients. CONCLUSIONS: Once-daily netarsudil resulted in IOP lowering that was noninferior to twice-daily timolol, with tolerable ocular AEs that were generally mild and self-resolving. As a first-in-class agent in the United States, with a novel mechanism of action, netarsudil may provide a useful therapeutic option for patients who would benefit from IOP lowering.

24-Hour Intraocular Pressure Control with Fixed-dose Combination Brinzolamide 1%/Brimonidine 0.2%: A Multicenter, Randomized Trial.

PURPOSE: To determine the intraocular pressure (IOP)-lowering effect of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) over a 24-hour period. DESIGN: Prospective, multicenter, double-masked, parallel-group clinical trial conducted at 16 academic and nonacademic sites in the United States. PARTICIPANTS: Subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT) aged ≥18 years with mean baseline IOP measurements in at least 1 eye of ≥21 and <28 mmHg. METHODS: Duplicate mean pneumatonometer IOP measurements were collected every 2 hours over a 24-hour period in controlled light conditions in overnight facilities. Daytime (8 am-8 pm) and nocturnal (10 pm-6 am) IOP measurements were collected in a sitting or supine position, respectively. Baseline 24-hour IOP was measured in untreated subjects after a washout (up to 4 weeks) and eligibility phase. After the baseline visit, participants were randomized 1:1 to receive masked BBFC or vehicle, 1 drop 3 times daily (8 am, 3 pm, and 10 pm) for 4 weeks. At week 4, IOP measurements were repeated in both groups under the same conditions. MAIN OUTCOME MEASURE: Mean change from baseline in 24-hour IOP at week 4. RESULTS: Of 125 participants randomized, 123 (98%; BBFC, n = 62; vehicle, n = 61) completed the study. No subjects randomized to BBFC discontinued the study. At week 4, BBFC-treated eyes had significantly reduced mean 24-hour IOP vs. vehicle (least squares mean difference [95% confidence interval]: -2.5 [-3.3, -1.7]; P < 0.001); daytime (-3.4 [-4.3, -2.6]; P < 0.001) and nocturnal (-1.2 [-2.3, 0.0]; P = 0.053) reductions were observed. Mean change from baseline was significantly different between BBFC- and vehicle-treated eyes at all daytime points and 3 of 5 nocturnal time points (10 pm, 12 am, and 6 am; secondary end point). The frequency of adverse events was similar between treatment groups; in the BBFC arm, ocular hyperemia, corneal abrasion, and dysgeusia were the most frequently reported, consistent with events described in the drug label. CONCLUSIONS: This large, multicenter study of 24-hour IOP control with BBFC met its primary end point; BBFC demonstrated significantly superior 24-hour IOP-lowering efficacy versus vehicle after 4 weeks of 3-times-daily treatment in subjects with OAG or OHT.

Five-Year, Prospective, Randomized, Multi-Surgeon Trial of Two Trabecular Bypass Stents versus Prostaglandin for Newly Diagnosed Open-Angle Glaucoma.

PURPOSE: To evaluate 5-year safety and efficacy of 2 trabecular micro-bypass stents versus prostaglandin as initial stand-alone treatment for newly diagnosed, treatment-naive primary open-angle glaucoma (POAG). DESIGN: Prospective, randomized, controlled, multi-surgeon clinical trial. PARTICIPANTS: Enrolled eyes (n = 101) were phakic and had a confirmed POAG diagnosis, normal angle anatomy, mean diurnal intraocular pressure (IOP) 21 to 40 mmHg, and vertical cup-to-disc (C:D) ratio ≤0.9. METHODS: Eyes were randomized (1:1) to receive either 2 stents (iStent trabecular micro-bypass; Glaukos Corporation, San Clemente, CA) or once-daily topical travoprost. MAIN OUTCOME MEASURES: The primary and secondary efficacy end points were the change from screening in mean diurnal IOP at months 12 and 24, respectively, without glaucoma surgery or add-on medication (any medication in stent eyes or a second medication in travoprost eyes). Two additional secondary end points were the proportion of eyes achieving treatment success at months 12 and 24, defined as IOP 6 to 18 mmHg without additional medication or glaucoma surgery. This report shows these efficacy measures through 60 months. Safety measures included best-corrected visual acuity, C:D ratio, visual field, pachymetry, complications, and adverse events. RESULTS: Of 101 enrolled eyes (54 stent eyes, 47 travoprost eyes), 90 eyes (49 stent eyes, 41 travoprost eyes) completed 5-year follow-up. Five-year mean diurnal IOP was 16.5±1.2 mmHg in stent eyes (35.3% reduced vs. 25.5±2.5 mmHg preoperatively; P < 0.0001) and 16.3±1.9 mmHg in travoprost eyes (35.1% reduced vs. 25.1±4.6 mmHg preoperatively; P < 0.0001). During follow-up, add-on medication was initiated in 12 stent eyes (22.2% of the initial 54-eyes) and 18 travoprost eyes (38.3% of the initial 47-eyes). By 5 years, 17% (6/35) of stent eyes and 44% (14/32) of travoprost eyes needed add-on medication to control IOP (P = 0.017). Treatment success was achieved in 77% (27/35) of stent eyes and 53% (17/32) of travoprost eyes (P = 0.04). Both groups exhibited excellent safety. CONCLUSIONS: This prospective randomized trial demonstrates 5-year effectiveness and safety of 2 trabecular bypass stents in patients with newly diagnosed, treatment-naive POAG, with comparably favorable outcomes as topical prostaglandin.

Are Disposable and Standard Gonioscopy Lenses Comparable?

PURPOSE: Gonioscopy is important in the evaluation and treatment of glaucoma. With increased scrutiny of acceptable sterilization processes for health care instruments, disposable gonioscopy lenses have recently been introduced. Single-time use lenses are theorized to decrease infection risk and eliminate the issue of wear and tear seen on standard, reusable lenses. However, patient care would be compromised if the quality of images produced by the disposable lens were inferior to those produced by the reusable lens. The purpose of this study was to compare the quality of images produced by disposable versus standard gonioscopy lenses. MATERIALS AND METHODS: A disposable single mirror lens (Sensor Medical Technology) and a standard Volk G-1 gonioscopy lens were used to image 21 volunteers who were prospectively recruited for the study. Images of the inferior and temporal angles of each subject's left eye were acquired using a slit-lamp camera through the disposable and standard gonioscopy lens. In total, 74 images were graded using the Spaeth gonioscopic system and for clarity and quality. Clarity was scored as 1 or 2 and defined as either (1) all structures perceived or (2) all structures not perceived. Quality was scored as 1, 2, or 3, and defined as (1) all angle landmarks clear and well focused, (2) some angle landmarks clear, others blurred, or (3) angle landmarks could not be ascertained. The 74 images were divided into images taken with the disposable single mirror lens and images taken with the standard Volk G-1 gonioscopy lens. The clarity and quality scores for each of these 2 image groups were averaged and P-values were calculated. RESULTS: Average quality of images produced with the standard lens was 1.46±0.56 compared with 1.54±0.61 for those produced with the disposable lens (P=0.55). Average clarity of images produced with the standard lens was 1.47±0.51 compared with 1.49±0.51 (P=0.90) with the disposable lens. CONCLUSIONS: We conclude that there is no significant difference in quality of images produced with standard versus disposable gonioscopy lenses. Disposable gonioscopy lenses may be an acceptable alternative to standard reusable lenses, especially in conditions where sterilization is difficult.

Corneal Haze as Prognostic Indicator of Intraocular Pressure in Primary Congenital Glaucoma.

PURPOSE: To perform a longitudinal analysis on the association of corneal haze with intraocular pressure (IOP) in eyes with primary congenital glaucoma (PCG) over 3 years. PATIENTS AND METHODS: Charts of all patients diagnosed with glaucoma of childhood from 2002 to 2012 at our institution were retrospectively reviewed. Inclusion criteria were age 18 years and below, plus elevated IOP or characteristic clinical signs. Exclusion criteria were eyes with secondary glaucoma or corneal haze not from PCG and patients with prior ocular surgery or incomplete follow-up. RESULTS: Of 79 eyes with childhood glaucoma during this period, 36 eyes had PCG [25 patients; 15 male (60.0%), 14 bilateral (56.0%)]. Eighteen eyes (13 patients) presented with corneal haze, whereas 18 eyes (12 patients) did not. Eyes with haze were diagnosed at a younger age than eyes without haze (0.79 vs. 5.2 y, P<0.02). During year 1, eyes with haze underwent significantly more IOP-lowering procedures and used significantly fewer IOP-lowering medications. Multivariate analysis revealed that corneal haze increased IOP by 4.63 mm Hg when controlling for treatment over time (P<0.01). Eyes with haze had lower survival curves and a failure hazard of 1.3 times that of eyes without haze. These eyes had a lower proportion of qualified successes than eyes without haze at year 1 (P<0.05) but this was reversed at year 3 (P<0.02). CONCLUSIONS: Eyes with PCG-related corneal haze generally presented more severely than did those without haze, but postmanagement outcomes may be similar to those in eyes without haze.

Effect of age and disc size on rim order rules by Heidelberg Retina Tomograph.

PURPOSE: The ISNT rule for nonglaucomatous eyes suggests that the neuroretinal rim is thickest at the inferior quadrant (I), followed by the superior (S), nasal (N), and temporal (T) quadrants. This study aimed to use Heidelberg Retina Tomograph (HRT III) measurements to assess (a) fulfillment of the ISNT rule and its derivatives in a large normative database and (b) effect of disc size and age on rule fulfillment. PATIENTS AND METHODS: A multicenter, prospective, cross-sectional study of a Caucasian normative database consisting of 280 subjects with normal comprehensive biomicroscopic examination, intraocular pressure <21 mm Hg, and normal automated visual field testing was conducted. Right eye neuroretinal rim and disc area, measured by HRT III, for each of the 4 quadrants were analyzed. Compliance of the rim area to the ISNT rule (I≥S≥N≥T) and its derivates was determined. Effect of age and disc area on rule compliance was further determined. RESULTS: Only 18% of normal eyes had rim areas that complied with the ISNT rule; however, a majority complied to IS (77%) and IST (73%) rules. The temporal quadrant had the smallest rim area [(I,S,N)>T] in 91% of patients. The likelihood of ISNT rule violation was increased in larger discs (χ², P=0.003) but was not affected by age. CONCLUSIONS: The ISNT rule does not apply to neuroretinal rim area as measured by HRT, as only 18% of the eyes complied with the ISNT rule in this normative database. Although the ISNT rule may be more applicable to normal eyes with a smaller disc area, the IS and IST rules seem to better represent the normative database.

Topical glaucoma therapy and ocular surface disease: a prospective, controlled cohort study.

OBJECTIVE: To evaluate the association between the intensity and duration of glaucoma topical therapy and severity of signs and symptoms of ocular surface disease (OSD). DESIGN: Single-site, prospective, controlled, cross-sectional study. PARTICIPANTS: Sixty-one patients with no diagnosis of or previous treatment for OSD were identified. METHODS: Patients were assigned to 2 groups: the glaucoma group with 31 patients diagnosed with primary open-angle glaucoma and using at least 1 topical intraocular pressure (IOP)-lowering medication and the control group including 30 patients with no diagnosis of glaucoma or history of topical therapy usage. The right eye of each patient was arbitrarily chosen. Each patient completed an Ocular Surface Disease Index (OSDI) questionnaire and underwent evaluation of the ocular surface by conjunctival and corneal lissamine green (LG) staining and tear breakup time (TBUT). The intensity index (drops/wk × therapy duration in years) was calculated to quantify the topical therapy. RESULTS: OSDI scores of the glaucoma group correlated to the intensity index (r = 0.46, CI 0.13-0.69). The glaucoma group had a higher mean OSDI score than the control group (18.97 ± 9.5 versus 6.25 ± 5.7, p = 5.85E-08). Abnormal TBUT and LG staining scores were prevalent in the glaucoma group compared with the control group (68% vs 17%, p = 0.000078; 65% vs 3%, p = 2.9E-07). CONCLUSIONS: Patients on glaucoma therapy have a greater prevalence of OSD symptoms, and their intensity index correlates to the OSDI score. The intensity index reflects quantitatively the amount of treatment and can be further validated in future studies as a predicting tool for OSD development.

New Technique of Exposed Glaucoma Drainage Tube Repair: Report of a Case.

We present the case of successful repair of an exposed glaucoma drainage tube by cornea graft fixation with tissue adhesive, and without subsequent coverage by adjacent conjunctiva or donor tissues. Patient with history of keratoglobus with thin cornea and sclera, and phthisical contralateral eye, underwent three unsuccessful corneal grafts followed by Boston type 1 keratoprosthesis in the right eye. Ahmed drainage device with sclera patch graft was implanted to control the intraocular pressure. Two years later the tube eroded through sclera graft and conjunctiva. Repair was performed by covering the tube with a corneal patch graft secured by tissue adhesive after the conjunctiva in this area was dissected away. The cornea graft was left uncovered due to fragility of adjacent conjunctiva. The healing of ocular and graft surfaces was complete prior to the 1 month follow-up. Conjunctival epithelium covered the corneal patch graft. At 12 months follow-up, the graft and the tube remained stable. Our report suggests that corneal patch graft fixation to the sclera by means of tissue adhesive, without closing the conjunctiva, can be considered as an effective alternative surgical approach for managing exposed glaucoma drainage tube, accompanied by adjacent conjunctiva tissue deficiency. How to cite this article: Berezina TL, Fechtner RD, Cohen A, Kim EE, Chu DS. New Technique of Exposed Glaucoma Drainage Tube Repair: Report of a Case. J Curr Glaucoma Pract 2015;9(2):62-64.

Intraocular pressure outcomes after endophthalmitis associated with glaucoma surgery.

PURPOSE: To determine long-term intraocular pressure (IOP) outcomes and risk factors for failure of IOP control in patients with previous glaucoma surgery that was complicated with infectious endophthalmitis. PATIENTS AND METHODS: Retrospective case series of 12 patients with previous glaucoma surgery that presented with infectious endophthalmitis to the University Hospital, Newark, NJ between 1995 and 2006. IOP control failure was stratified into 2 groups: IOP of ≥22 mm Hg and IOP ≥16 mm Hg at 3 consecutive follow-up visits. A Kaplan-Meier survival analysis was used to determine failure rate and Cox proportional hazards model to analyze effects of pertinent variables on survival. P values <0.05 were considered statistically significant. RESULTS: Twelve patients that had previously undergone glaucoma surgery (8 trabeculectomies and 4 bleb revisions) and were complicated with infectious endophthalmitis were identified. Mean follow-up time was 43.7 months (range, 10 to 98 mo). Of 12 patients, 9 (75%) failed, 2 (17%) consistently maintained IOP<22 mm Hg, and 1 (8%) maintained IOP<16 mm Hg during the follow-up period. Median survival time was 9.25 months. Age of the subject 65 years and older (P=0.0002) was associated with increased risk of IOP failure, whereas initial treatment selection with vitrectomy did not. Six patients required additional glaucoma surgery during the follow-up period. CONCLUSIONS: IOP control after resolution of endophthalmitis in patients with previous glaucoma surgery was maintained in only 25% of cases. Half the patients required additional glaucoma surgery.

Combined pars plana vitrectomy and pars plana Baerveldt tube placement in eyes with neovascular glaucoma.

PURPOSE: To describe characteristics and outcomes of combined pars plana vitrectomy and Baerveldt tube insertion procedure from 2005 to 2010 in eyes with neovascular glaucoma. METHODS: Seventy-nine patients (89 eyes) with ≥2 months of follow-up were included. Outcome measures were visual acuity, intraocular pressure (IOP), number of glaucoma medications, and complications. Changes in mean logMAR visual acuity, IOP, and glaucoma medications were compared by a two-tailed t-test. RESULTS: Mean patient age was 69.0 years. Forty-three (54%) were male. Mean follow-up time was 19.9 months. Most common causes of neovascular glaucoma was diabetes (n = 63 [71%]) and central retinal vein occlusion (n = 21 [24%]). Eighty-six eyes (97%) underwent a 250 mm Baerveldt drainage device and 3 (3.4%) a 350 mm Baerveldt. Forty-five (51%) 20-gauge, 12 (13%) 23-gauge, and 32 (36%) 25-gauge pars plana vitrectomies were performed. Fifty-two eyes (58%) preoperatively and 23 (33%) postoperatively received intraocular injections for rubeosis and macular edema. Mean ± standard deviation logMAR visual acuity at 18-, 24-, 36-, and 48-month follow-up time points was significantly better than preoperative vision (P < 0.05). Preoperative versus final IOP and number of glaucoma medications were significantly decreased (P < 0.05). Fourteen eyes (16%) had a final visual acuity of no light perception. Most common complications included transient ocular hypertension (n = 82 [92%]), transient hypotony (n = 20 [22%]), hyphema (n = 19 [21%]), corneal edema (n = 17 [19%]), and vitreous hemorrhage (n = 14 [16%]). The frequency of transient hypotony, vitreous hemorrhage, and rubeosis was significantly (P < 0.05) higher in 20-gauge versus 23-/25-gauge pars plana vitrectomy eyes. Nine eyes (10%) required return to the operating room after combined procedure, including 4 eyes (4.5%) for retinal detachment and 3 (3.4%) for high IOP due to tube occlusion. Three eyes (3.4%) developed endophthalmitis and 2 (2.2%) progressed to being pre/phthisical (none were enucleated). CONCLUSION: Combined pars plana vitrectomy and Baerveldt glaucoma shunt may be a useful procedure in reducing IOP and number of glaucoma medications in eyes with neovascular glaucoma along with stabilizing visual acuity in a majority of these eyes. Further studies are warranted to verify and expand on these findings.

Repeat selective laser trabeculoplasty can be effective in eyes with initial modest response.

PURPOSE: To evaluate the effectiveness of repeat selective laser trabeculoplasty (SLT) in eyes exhibiting only a modest response upon initial treatment. MATERIALS AND METHODS: Retrospective chart review was conducted of 51 eyes that received initial 360 degree SLT (SLT1) and subsequent SLT (SLT2) from 2003-2011 at a large academic ophthalmology practice. Successful response (S) was a post-treatment 12 month mean IOP reduction ≥ 20% from baseline, while modest response (M) was <20% reduction over the same time. Chi-squared and log rank analyses were used to determine if success after SLT2 depended on having successful (S1) or modest (M1) response after SLT1. RESULTS: IOP was significantly reduced from baseline in both SLT1 and SLT2. The proportion of eyes with S2 was not significantly different between those with initial M1 or S1 (36.67% vs. 52.38%, respectively; P = 0.26). Log rank analysis revealed no differences between M1 and S1 in determining SLT2 success (P = 0.41). This outcome was similar when the analyses were performed for the right and left eye independently. CONCLUSION: The proportion of eyes that successfully responded to repeat SLT did not differ based upon whether the response to initial SLT was successful or modest. This raises the possibility that repeat SLT should not be excluded as an option for those eyes that have only a modest initial response.

Fixed-combination intraocular pressure-lowering therapy for glaucoma and ocular hypertension: advantages in clinical practice.

INTRODUCTION: Several large, randomized, prospective clinical trials have demonstrated that medical therapy to reduce intraocular pressure (IOP) delays the onset and decreases progression of glaucoma. Many patients with glaucoma require more than one ocular hypotensive medication to achieve and maintain their target IOP; however, use of multiple topical glaucoma preparations is associated with factors that may decrease treatment efficacy and increase adverse effects. AREAS COVERED: This article reviews the use of fixed-combination therapies in glaucoma management, the relationship between IOP management and disease progression and challenges associated with glaucoma therapy when multiple instillations are required. Specific topics discussed include IOP-lowering efficacy, adherence and persistence, preservative exposure and washout-related risk of diminished IOP reduction. Potential benefits of fixed combinations versus multiple non-fixed medications are reviewed based on a detailed literature search. EXPERT OPINION: Compared with non-fixed combinations, fixed-combination glaucoma therapies provide various demonstrated benefits (similar IOP-lowering efficacy with reduced exposure to preservatives and risk of preservative-related ocular surface disease symptoms, elimination of washout associated with insufficient time separation of instillations and reduced number of total instillations). Further, due to simplification of the instillation regimen, fixed combinations may improve treatment adherence and persistence, thereby improving stability of IOP control over time.

Technique for removal of malpositioned Ex-PRESS glaucoma device.

PURPOSE: To report a simple technique for removal of malpositioned Ex-PRESS miniature glaucoma filtration device. PATIENT AND METHODS: A patient who underwent removal of a malpositioned Ex-PRESS shunt from the right eye with wound revision. RESULTS: Description of step-by-step technique for removal of the Ex-PRESS shunt. The site healed well and a tube shunt was inserted 6 weeks later for intraocular pressure control. CONCLUSIONS: This technique may assist surgeons in the safe and controlled removal of an Ex-PRESS shunt in cases of malpositioning, impending exposure, or extrusion.

Long term efficacy of repeat selective laser trabeculoplasty.

PURPOSE: To evaluate long term intraocular pressure (IOP) control after repeat selective laser trabeculoplasty (SLT). METHODS: This single center study retrospectively reviews the electronic medical records of patients with open angle glaucoma undergoing repeat SLT. Eyes with prior argon laser trabeculoplasty, or incisional surgery before or during the study period were excluded. Demographics, laser parameters, number of glaucoma medications and IOP at baseline and after 1, 4, 8, 12, 18 and 24 months were collected. The percentage of subjects with IOP reduction >20% and ≥15% from baseline was determined. RESULTS: A total of 45 eyes of 25 subjects with mean age of 73 ± 9 years undergoing repeat SLT were included. Repeat SLT was performed at a mean interval of 28.3 ± 12.7 months after initial treatment. Mean IOP reductions were statistically significant with repeat SLT as compared to baseline at 1, 4, 8, 12, 18 and 24 months' follow-up. Change in IOP after first and repeat SLT were comparable at most time points except at 4, 8 and 12 months when initial treatment had yielded significantly greater reductions. At 24 months, 29% and 39% of eyes achieved IOP reduction >20% and ≥15% respectively after repeat SLT as compared to 36% and 54% of eyes following initial treatment (P > 0.05). CONCLUSION: Repeat SLT is effective in lowering IOP up to 24 months. Long term IOP control was achieved in 29-39% of eyes following repeat treatment in this cohort of patients.

Selective laser trabeculoplasty: Does energy dosage predict response?

BACKGROUND: Selective laser trabeculoplasty (SLT) is a widely used treatment for open angle glaucoma, producing sustained reductions of intraocular pressure (IOP). The aim of this study was to evaluate the long-term relationship between SLT energy dosage and IOP reduction. MATERIALS AND METHODS: A retrospective review was performed for patients receiving primary SLT therapy, with inclusion of subjects treated with 360° of SLT. Energy settings were collected upon treatment and IOP was collected at baseline up to 36 months. Pearson's correlation coefficient was used to determine whether there was a significant correlation between SLT energy and IOP reduction at all time points. Kaplan-Meier analysis with log-rank test was performed to determine the differences in IOP reduction ≥20% from baseline among those treated with low (<85 mJ), medium (85-105 mJ), and high (>105 mJ) energy SLT. RESULTS: A total of 104 eyes (75 patients) were included. The mean total SLT energy was 93.73 mJ (standard deviation (SD) = 21.83 mJ, range: 34.4-122 mJ). A significant positive correlation (P ≤ 0.05) between the amount of energy delivered and IOP reduction was found at all time points. Log-rank test showed a significant difference in IOP reduction ≥20% from baseline between the three energy groups, with low energy patients experiencing failure at an earlier time (P = 0.05). CONCLUSIONS: Within the range of total energy examined, there is a positive correlation between total energy used and amount of pressure reduction achieved at up to 3 years of follow-up. This may be useful in determining the optimal energy dosage for maximum effect for patients receiving SLT.

Technique for intraoperative reuse of Ex-PRESS delivery system.

PURPOSE: To report a new technique for reloading the Ex-PRESS glaucoma filtration device on the Ex-PRESS delivery system (Alcon Laboratories) for revised placement of an implant. PATIENT AND METHODS: The Ex-PRESS is provided on a single-use delivery system. A patient who underwent Ex-PRESS placement was noted intraoperatively to have had an unsatisfactory implant position upon initial insertion. The used inserter metallic rod was manipulated to resume its original shape. The implant was removed and reloaded onto the delivery system, which was then used to place it in the desired position. RESULTS: Intraoperative delivery system reloading is possible and facilitates repositioning of the Ex-PRESS implant. CONCLUSIONS: This technique for reloading the Ex-PRESS will allow the surgeon to make adjustments to an unsatisfactorily positioned implant upon initial insertion. This may help optimize implant positioning, minimize insertion malpositioning, and reduce the cost and time of using more than 1 device.

Visual field and ocular safety during short-term vigabatrin treatment in cocaine abusers.

PURPOSE: To evaluate the ocular safety of short-term vigabatrin treatment of cocaine abuse. DESIGN: Multicenter, prospective, randomized, placebo-controlled, double-masked, parallel assignment study. METHODS: Cocaine addicts were randomized to receive vigabatrin 3000 mg/day, cumulative dose 218 g (n = 92), or placebo (n = 94) for 12 weeks. Subjects underwent examination of visual acuity (ETDRS) and peripheral visual field (PVF) by Humphrey Field Analyzer (HFA) 60-4 program before and after treatment. Reliable PVF tests (fixation loss, false positive, and false negative <33%) for 103 subjects were included for the analysis. The threshold visual sensitivity (TVS) was analyzed by points, rings and zones. Main outcome measures included visual acuity decrease by 15 letters and/or significant PVF alteration, defined as 5 or more visual field location points having greater than or equal to 15 dB reduction in TVS or decline (≥33% loss) in posttreatment TVS for 1 or more rings. RESULTS: Visual acuity decrease was detected in 1 eye of a subject receiving placebo and in none receiving vigabatrin. Posttreatment reduction in TVS more than 15 dB in 5 or more adjacent visual field location points combined with reduction in TVS greater than 33% in 1 or more of the rings was detected in 2 of 54 subjects (3.7%) from the vigabatrin group and in 1 of 49 subjects (2%) from the placebo group (P = .9, NS). None of the PVF changes were bilateral or concentric. CONCLUSIONS: Short-term use of vigabatrin did not cause a decrease in visual acuity or significant peripheral visual field changes in cocaine abusers.

Pars plana Baerveldt tube insertion with pars plana vitrectomy for refractory glaucoma.

BACKGROUND: Glaucoma drainage implants (GDIs) are used for managing recalcitrant glaucoma and are usually placed in the anterior chamber. This approach may lead to complications such as corneal decompensation, and so a pars plana approach is used in at risk eyes. AIMS: To compare functional outcomes and complications of 250 mm(2) and 350 mm(2) pars plana Baerveldt tube insertion with pars plana vitrectomy (PPV) (both 20- and 23-gauge) for managing refractory glaucoma. SETTINGS AND DESIGN: A retrospective chart review of 38 patients (39 eyes) undergoing combined PPV-Baerveldt procedure for glaucoma recalcitrant to maximal medical treatment or previous filtering procedures with >6 weeks of follow-up. MATERIALS AND METHODS: Main outcome measures were visual acuity, intraocular pressure (IOP), number of glaucoma medications, and postoperative complications. STATISTICAL ANALYSIS USED: A paired 't' test was used to evaluate changes in IOP and glaucoma medications, Fisher's exact test was used to compare complication rates, and Kaplan-Meier survival curves were constructed for comparison of overall outcomes. RESULTS: Mean patient age was 62.2 years. Mean follow-up period was 33.7 months, with 36 (92%) eyes followed for ≥6 months. Mean±SD preoperative IOP and number of glaucoma medications were significantly reduced by the combined procedure (P<0.05). Thirty-five (90%) eyes maintained final IOP between 6 and 21 mmHg. Vision improved by ≥2 lines in 10 (26%) eyes, remained stable in 15 (38%) eyes, and decreased in 14 (36%) eyes. Two (5.1%) eyes developed no light perception vision, with one (2.6%) eye becoming phthisical. Twenty-four (62%) eyes developed complications managed with conservative measures. Five (13%) eyes required ≥1 surgeries within a year of the combined procedure. CONCLUSIONS: Pars plana Baerveldt tube implantation with PPV can preserve vision, reduce IOP, and decrease the number of glaucoma medications necessary to achieve target IOP in patients with recalcitrant glaucoma.

A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography-tandem mass spectrometry.

BACKGROUND: This work compares the concentration of active ingredients and preservatives in commonly used brand name versus generic glaucoma medications. MATERIALS AND METHODS: Active ingredient and benzalkonium chloride (BAK) concentrations in brand name latanoprost and dorzolamide-timolol were each compared to two generic counterparts using liquid chromatography-mass spectrometry at baseline and after exposure to 25°C and 50°C for 30 days. Micro flow imaging was used to quantify particulate material greater than one micron in diameter. RESULTS: Brand name formulations contained active ingredients and BAK in concentrations that were generally in agreement with their package inserts at baseline. The two generic formulations of latanoprost contained baseline levels of active ingredients that were 10% greater than their labeled value. Generic latanoprost formulations had significant loss of active ingredient concentration after exposure to 25°C and 50°C for 30 days. Both generic and brand name dorzolamide-timolol appeared relatively resistant to degradation. BAK concentrations remained stable at 25°C but decreased in some bottles at 50°C. Bottles of both generic medications had higher levels of particulate matter compared to brand name versions. CONCLUSIONS: Exposure to temperatures at the high end of the labeled value may lead to a significant decrease in concentration of active ingredients in generic formulations that could influence clinical efficacy. Re-evaluation of intraocular pressure lowering efficacy may be indicated in glaucoma patients switching from brand name to generic formulations.