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.

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.

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.

Long-term incidence and timing of intraocular hypertension after intravitreal triamcinolone acetonide injection.

PURPOSE: To describe the long-term incidence and timing of steroid-induced ocular hypertension after intravitreal triamcinolone acetonide (IVTA) therapy. DESIGN: Retrospective case series of 929 eyes of 841 patients. PARTICIPANTS: Patients with a variety of posterior segment disorders in a single group practice. INTERVENTION: Pars plana injection of IVTA. MAIN OUTCOME MEASURES: Intraocular pressure (IOP) and requirement for glaucoma surgery. RESULTS: Overall, 929 eyes received >or=1 injections (mean, 1.6) of 4 mg of IVTA. During a mean follow-up period of 14+/-6.9 months, the Kaplan-Meier cumulative incidences of IOP elevations >21 mmHg at 6, 12, 18, and 24 months post-injection were 28.2%, 34.6%, 41.2%, and 44.6%, respectively; similarly, the incidences of eyes with IOP measurements >25 mmHg were 14.6%, 19.1%, 24.1%, and 28.2%, respectively. At the same time points, IOP-lowering medications were required by 13.0%, 16.9%, 20.7%, and 24.2% of eyes, respectively. Only 3 eyes (0.3%) required IOP-lowering surgery. Preexisting glaucoma, younger age, and a history of an IOP elevation after a previous IVTA injection were risk factors for IOP elevations after IVTA injection. The minimum and maximum follow-up were 3 weeks and 37 months. The mean rate of attrition in this study was 3% per month. CONCLUSIONS: Elevations in IOP after IVTA injection are common. Younger patients and eyes with preexisting glaucoma or a history of a steroid response should be monitored more closely for IOP elevations after IVTA therapy.

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.

Software-assisted optic nerve assessment for glaucoma tele-screening.

Increased optic nerve head (ONH) cup-to-disc ratio (CDR) may indicate glaucoma but evaluation needs to be performed by a trained examiner. This research assessed new software to calculate CDR from ONH images. Digital stereoscopic ONH images from 28 subjects acquired during screening using a nonmydriatic 45-degree camera with 8.2-Megapixel resolution (Canon, Tokyo, Japan) were analyzed by 3 individuals with different levels of ophthalmic training: glaucoma specialist (GS), an optometrist (OD), and trainees. Images were logged and accessed by raters masked to each other's evaluations. Images from two groups were included: normal-appearing ONH (Group 1) and confirmed glaucoma (Group 2). All images were captured in DICOM format. Images were evaluated on a 32-bit, 1,600 x 1,200-pixel resolution monitor. EyeScape software (v. 7.4, Synemed, Inc., Benicia, CA) was used for CDR analysis. Software CDR determination requires an operator to place ONH disc and cup contour lines. Once lines were placed, the software provided CDR calculations (range 0.00-1.00). A total of 84 ONH evaluations were analyzed. Overall CDR mean, standard deviation, standard error of the mean, and mean difference from GS CDR evaluations were determined. Reproducibility was similar for all operators. The trainee had a small, statistically significant greater CDR in group 1 and 2 evaluations. Evaluation of ONH images for CDR can be performed using EyeScape software, by individuals with different levels of ophthalmic training. Accurate determination of CDR is important in tele-screening for vision-threatening diseases, and can aid in identifying subjects with suspicious ONH in need of specialty eye care.

Corneal thickness measurement in the management of primary open-angle glaucoma: a report by the American Academy of Ophthalmology.

OBJECTIVE: To evaluate published literature to assess whether central corneal thickness (CCT) is a risk factor for the presence, development, or progression of glaucomatous optic nerve damage related to primary open-angle glaucoma (POAG). METHODS: A PubMed literature search limited to English language articles conducted on November 15, 2004 retrieved 195 articles. The authors reviewed these abstracts and selected 57 to review in full text to determine relevance to the assessment questions. A further 24 studies of interest were identified from periodic updates to the literature search, surveillance of the literature, and reference lists of reviewed articles. From the 81 published reports identified, the first author applied specified selection criteria that yielded 37 articles for methodological review because of relevance to the assessment questions. The articles were rated according to the strength of evidence by the panel methodologist. A level I rating was assigned to well-designed properly conducted randomized clinical trials or similar quality-validated cohort studies with appropriate reference standards. A level II rating was assigned to well-designed case-control studies, exploratory cohort studies, and other nonrandomized clinical studies lacking consistently applied reference standards. A level III rating was reserved for poorly designed case-control studies, case series, and papers consisting only of expert opinion without supporting evidence. In addition, each study was graded as positive if it supported a statistical association of CCT with the risk of having or developing glaucomatous optic nerve damage or as negative if no such association was found. RESULTS: There is strong and consistent level I and level II evidence that CCT is a risk factor for progression from ocular hypertension to POAG. Studies that were rated as providing the highest quality of evidence revealed mixed results with respect to glaucoma prevalence. One population-based study (level II) showed a positive association, another larger study (level I) revealed an association of marginal significance, and 3 studies (all level I) found no association of CCT with POAG prevalence. CONCLUSIONS: There is strong evidence that measuring CCT is an important component of a complete ocular examination, particularly for patients being evaluated for the risk of developing POAG. Therefore, CCT measurement should be included in the examination of all patients with ocular hypertension. Although the evidence supporting the necessity of measuring CCT as part of screening for POAG or as a risk factor for glaucoma progression is not as strong, intraocular pressure (IOP) is the only modifiable risk factor in the treatment of glaucoma, and CCT has the potential to significantly impact IOP measurement by applanation tonometry in all patients.

Optic nerve head and retinal nerve fiber layer analysis: a report by the American Academy of Ophthalmology.

OBJECTIVE: To evaluate the current published literature on the use of optic nerve head (ONH) and retinal nerve fiber layer (RNFL) measurement devices in diagnosing open-angle glaucoma and detecting progression. METHODS: A search of peer-reviewed literature was conducted on February 15, 2006 in PubMed and the Cochrane Library for the period January 2003 to February 2006. The search was limited to studies of adults in English-language journals and yielded 442 citations. The panel reviewed the abstracts of these articles and selected 159 articles of possible clinical relevance for review. Of these 159 full-text articles, 82 were determined to be relevant for the first author and methodologist to review and rate according to the quality of evidence. RESULTS: There were no studies classified as having the highest level of evidence (level I). The ONH and RNFL imaging instruments reviewed in this assessment were determined to be highly effective in distinguishing eyes with glaucomatous visual field (VF) loss from normal eyes without VF loss, based on level II evidence. In addition, some studies demonstrated that parameters from ONH or RNFL imaging predicted the development of VF defects among glaucoma suspects. Studies on detecting glaucoma progression showed that although there was often agreement on progression between the structural and functional (VF) tests, a significant proportion of glaucoma patients progressed by either the structural or the functional test alone. CONCLUSIONS: The ONH and RNFL imaging devices provide quantitative information for the clinician. Based on studies that have compared the various available technologies directly, there is no single imaging device that outperforms the others in distinguishing patients with glaucoma from controls. Ongoing advances in imaging and related software, as well as the impracticalities associated with obtaining and assessing optic nerve stereophotographs, have made imaging increasingly important in many practice settings. The information obtained from imaging devices is useful in clinical practice when analyzed in conjunction with other relevant parameters that define glaucoma diagnosis and progression.

Use of fixed-dose combination drugs for the treatment of glaucoma.

Glaucoma is a leading cause of irreversible visual loss. This potentially blinding disease is a progressive optic neuropathy associated with elevated intraocular pressure (IOP). Initial therapy for glaucoma typically consists of topical medications or laser treatment to lower IOP. Frequently, more than one medication is required to achieve adequate control of IOP. However, more medications means more bottles and greater complexity for the patient. There are several potential benefits of fixed combination medications compared with using the individual components separately. These include a reduction in the total number of drops and preservative instilled per day, cost savings, improved tolerability and compliance and avoiding the washout effect resulting from rapid-sequence instillation of multiple drops. Attempts to develop effective fixed combinations of glaucoma medications date back several decades. In recent years, fixed combinations of commonly paired drugs have been approved by various regulatory bodies in different countries and have gained wide acceptance. Current commercially available, fixed combination drugs include the topical beta-adrenoceptor antagonist timolol 0.5% combined with a prostaglandin, a topical carbonic anhydrase inhibitor or an alpha-adrenoceptor agonist. Although there is no uniformity among registration trial designs, most published literature compares the efficacy of the fixed combination to the individual components and to concomitant use of both components. Various factors inherent to study design such as medication run-in, washout periods and peak and trough effects have to be taken into consideration when analysing the demonstrated efficacy of fixed combinations. Fixed combination treatments offer effective IOP control while reducing the washout effect and exposure to preservatives. They are also convenient. However, fixed combinations also remove the possibility of titrating the individual components both in terms of concentration and timing of administration. In addition, fixed combinations might not always provide the same efficacy as proper use of the individual components. The clinician must make individualised assessments when weighing the convenience of these medications against their limitations for specific patients.

DICOM transmission of simultaneous stereoscopic images of the optic nerve in patients with glaucoma.

We evaluated the Digital Imaging and Communications in Medicine (DICOM) standard for the transmission of stereoscopic images of the optic nerve. Digital optic nerve images were obtained from patients with glaucoma. Fifteen simultaneous stereo images from consecutive patients were analysed independently twice, in random order, by two glaucoma specialists to establish baseline values of vertical and horizontal cup-to-disc (CDV and CDH) ratios and image quality (1 = worst, 5 = best). Images were transmitted to a distant location and returned to the sending site using DICOM standards in both directions. The received images were reassessed again by the two glaucoma specialists. The image file size slightly increased for all received images (mean 2545 kByte) in comparison with the transmitted images (mean 2460 kByte). The mean baseline values for CDV, CDH and quality score were 0.66, 0.59 and 3.9, respectively. The corresponding mean values for the received images were 0.66, 0.62 and 3.73, respectively. The differences between transmitted and received images were not significant. Clinical interpretation of digital stereoscopic images of glaucomatous optic nerves appears to be unaffected by DICOM capture and transmission.

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.

Short-term treatment of cocaine and/or methamphetamine abuse with vigabatrin: ocular safety pilot results.

OBJECTIVE: To evaluate the ocular safety of short-term use of vigabatrin to treat cocaine and/or methamphetamine addiction. METHODS: Individuals who were actively using cocaine and/or methamphetamine were eligible for enrollment. Enrolled subjects were scheduled for comprehensive eye examinations at the beginning and end of the study. Visual field testing was performed at baseline and 1 week, 4 weeks, 8 weeks, and 1 month or more after discontinuing vigabatrin. Twenty-eight subjects received at least 1 dose of vigabatrin; however, only 20 subjects continued beyond the initial escalating vigabatrin dose phase to the treatment phase. Of these 20 subjects, 18 completed the study with full follow-up. Visual fields were evaluated subjectively by 2 glaucoma specialists and analyzed objectively for group and individual changes in quadrant mean sensitivity. The objective analysis was also repeated for superior field quadrants after excluding the uppermost peripheral points to minimize the eyelid effect. The main outcome measures were change of visual field, visual acuity, and ocular adverse effects. RESULTS: Vigabatrin seemed to help treat cocaine and/or methamphetamine addiction. Of 18 subjects, 16 had negative test results for cocaine and methamphetamine use during the last 6 weeks of the trial. No ocular adverse events were detected. The subjective evaluation did not reveal visual field constriction in any of the 18 evaluable participants. Objective group and individual analyses for quadrant mean sensitivity did not show any change from baseline in any quadrant. No changes in visual acuity were noted. CONCLUSIONS: In this short-term pilot study, vigabatrin seemed to help treat cocaine and/or methamphetamine abuse. There was no evidence of ocular or visual field adverse effects.

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.

Efficacy of the dorzolamide/timolol fixed combination versus latanoprost in the treatment of ocular hypertension or glaucoma: combined analysis of pooled data from two large randomized observer and patient-masked studies.

In previous analyses of primary efficacy data from two randomized clinical trials, standard dosing regimens of the dorzolamide/timolol fixed combination (COSOPT) and latanoprost (XALATAN) were shown to have equivalent efficacy with regard to reduction in mean daytime diurnal intraocular pressure (IOP). We performed additional post hoc analyses of pooled data from these studies to compare further the efficacy of the two treatments. The studies used identical 3-month, parallel group, randomized, observer-masked and patient-masked, multicenter designs. Patients with a baseline IOP > or = 24 mm Hg were randomized to either the 2% dorzolamide/0.5% timolol combination eye drops twice daily (n = 273) or 0.005% latanoprost eye drops once daily (n = 271). The IOP measurements were made at 8 AM, 10 AM, 2 PM, and 4 PM at the baseline visit and then on each of the 3 monthly assessment days. The following measures were analyzed on a post hoc basis: 1) percentages of patients meeting target levels of IOP reduction; 2) mean IOP reduction in those patients with high IOP (> or =30 mmHg) at baseline; 3) mean IOP at each of the assessment time points during a day. A total of 259 patients in the dorzolamide/timolol group and 268 patients in the latanoprost group were included in the efficacy analysis. At 3 months, both treatments showed similar efficacy with regard to the percentages of patients who achieved target levels of IOP reduction (e.g., 40% IOP reduction in 15% of dorzolamide/timolol combination patients and 13% of latanoprost patients), mean IOP reduction in those patients with high IOP at baseline (dorzolamide/ timolol combination, 12.5 mmHg, latanoprost, 12.6 mmHg), and mean IOP at each time point during the day. By the measures used in this analysis, the dorzolamide/timolol combination and latanoprost were equally effective at lowering IOP in patients with ocular hypertension or glaucoma.

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.

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.

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.

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.

Antifibrotics and wound healing in glaucoma surgery.

When medical and laser therapy fail to control intraocular pressure, glaucoma filtration surgery needs to be performed. Glaucoma surgery is unique in that its success is linked to interruption of the wound-healing response in order to maintain patency of the new filtration pathway. In this article we will review the wound-healing pathway and the pharmacologic interventions that have been employed clinically and experimentally to interrupt wound healing, particularly steroids and the antifibrotic agents 5-fluorouracil and mitomycin C. A review of the published literature looking at use of these agents to enhance success as well as the associated complications are presented, critiqued, and interpreted in order to put the studies in proper perspective. Future directions and recommendations regarding use of these agents are available and an introduction to newer wound modulating agents such as anti-transforming growth factor beta 2 is presented.