The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C.

PURPOSE: To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery. METHODS: Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications. CONCLUSIONS: Practice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.

A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C.

PURPOSE: To compare the safety and efficacy of Baerveldt implantation (Abbott Medical Optics, Santa Ana, CA) and trabeculectomy with mitomycin C (MMC) in patients who have not undergone prior incisional ocular surgery. DESIGN: Retrospective, comparative case series. PARTICIPANTS: A total of 125 patients with low-risk glaucoma undergoing primary glaucoma surgery, including 55 patients who received a 350-mm(2) Baerveldt glaucoma implant and 70 patients who underwent trabeculectomy with MMC. METHODS: Eligible patients were identified using Current Procedural Terminology codes, and their medical records were reviewed retrospectively. MAIN OUTCOME MEASURES: The primary outcome measure was surgical success (intraocular pressure [IOP] ≤21 mmHg and reduced ≥20% from baseline, IOP >5 mmHg, no reoperation for glaucoma, no loss of light-perception vision). Secondary outcome measures included visual acuity, IOP, number of glaucoma medications, and complications. RESULTS: The cumulative probability of success at 3 years with or without medical therapy was 87% in the Baerveldt group and 76% in the trabeculectomy group (P = 0.23). Postoperative complications occurred in 11 patients (20%) in the Baerveldt group and 20 patients (29%) in the trabeculectomy group (P = 0.27). Mean follow-up ± standard deviation was 27±19 months in the Baerveldt group and 34±20 months in the trabeculectomy group (P = 0.053). CONCLUSIONS: Similar rates of surgical success and postoperative complications were observed in patients undergoing trabeculectomy with MMC and in those undergoing Baerveldt implantation during 3 years of follow-up. Both are viable primary glaucoma procedures in patients who have not undergone prior ocular surgery.

Gene Therapy for Leber Hereditary Optic Neuropathy: Initial Results.

PURPOSE: Leber hereditary optic neuropathy (LHON) is a disorder characterized by severe and rapidly progressive visual loss when caused by a mutation in the mitochondrial gene encoding NADH:ubiquinone oxidoreductase subunit 4 (ND4). We have initiated a gene therapy trial to determine the safety and tolerability of escalated doses of an adeno-associated virus vector (AAV) expressing a normal ND4 complementary DNA in patients with a G to A mutation at nucleotide 11778 of the mitochondrial genome. DESIGN: In this prospective open-label trial (NCT02161380), the study drug (self-complementary AAV [scAAV]2(Y444,500,730F)-P1ND4v2) was intravitreally injected unilaterally into the eyes of 5 blind participants with G11778A LHON. Four participants with visual loss for more than 12 months were treated. The fifth participant had visual loss for less than 12 months. The first 3 participants were treated at the low dose of vector (5 × 10(9) vg), and the fourth participant was treated at the medium dose (2.46 × 10(10) vg). The fifth participant with visual loss for less than 12 months received the low dose. Treated participants were followed for 90 to 180 days and underwent ocular and systemic safety assessments along with visual structure and function examinations. PARTICIPANTS: Five legally blind patients with G11778A LHON. MAIN OUTCOME MEASURES: Loss of visual acuity. RESULTS: Visual acuity as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart remained unchanged from baseline to 3 months in the first 3 participants. For 2 participants with 90-day follow-up, acuity increased from hand movements to 7 letters in 1 and by 15 letters in 1, representing an improvement equivalent to 3 lines. No one lost vision, and no serious adverse events were observed. Minor adverse events included a transient increase of intraocular pressure (IOP), exposure keratitis, subconjunctival hemorrhage, a sore throat, and a transient increase in neutralizing antibodies (NAbs) against AAV2 in 1 participant. All blood samples were negative for vector DNA. CONCLUSIONS: No serious safety problems were observed in the first 5 participants enrolled in this phase I trial of virus-based gene transfer in this mitochondrial disorder. Additional study follow-up of these and additional participants planned for the next 4 years is needed to confirm these preliminary observations.

REPRODUCIBILITY AND COMPARISON OF VISUAL ACUITY OBTAINED WITH SIGHTBOOK MOBILE APPLICATION TO NEAR CARD AND SNELLEN CHART.

PURPOSE: To investigate test-retest reproducibility of visual acuities obtained with a popular mobile application (app) and to explore the agreement with the standard clinic charts. METHODS: Records of patients who had visual acuity measured during the same routine clinic visit with Snellen chart, Rosenbaum near vision card, and SightBook mobile app were reviewed. Acuities were converted to approximate ETDRS letters for statistical purposes. RESULTS: One hundred and twenty-six patients were identified. SightBook, Snellen, and near card acuities had excellent test-retest reproducibility. SightBook acuities were significantly different from the near card acuities (mean absolute difference of 5.4 and 6.1 letters in the right and left eyes) and the Snellen acuities (mean absolute difference of 7.7 and 7.9 letters in the right and left eyes). The agreement was also poor between the near card and the Snellen acuities (mean absolute difference of 6.4 and 7.6 letters in the right and left eyes). CONCLUSION: The discrepancy between SightBook mobile app and the clinic charts acuities may be large; however, the results are highly reproducible. Obtaining baseline SightBook acuity allows future vision comparisons. SightBook mobile app offers a new portable vision assessment tool for the office and remote patient monitoring.

Five-year treatment outcomes in the Ahmed Baerveldt comparison study.

PURPOSE: To compare the 5-year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt 101-350 Glaucoma Implant (BGI) (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. DESIGN: Multicenter, randomized, controlled clinical trial. PARTICIPANTS: A total of 276 patients, including 143 in the AGV group and 133 in the BGI group. METHODS: Patients aged 18 to 85 years with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥18 mmHg in whom glaucoma drainage implant (GDI) surgery was planned were randomized to implantation of an AGV or a BGI. MAIN OUTCOME MEASURES: Surgical failure, IOP, visual acuity (VA), use of glaucoma medications, and complications. RESULTS: At 5 years, IOP (mean ± standard deviation [SD]) was 14.7±4.4 mmHg in the AGV group and 12.7±4.5 mmHg in the BGI group (P = 0.015). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2±1.4 in the AGV group and 1.8±1.5 in the BGI group (P = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group (P = 0.65). The number of subjects failing because of inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures; P = 0.003). Eleven eyes in the AGV group (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared with 22 eyes (47% of failures) in the BGI group. Change in logarithm of the minimum angle of resolution VA (mean ± SD) at 5 years was 0.42±0.99 in the AGV group and 0.43±0.84 in the BGI group (P = 0.97). CONCLUSIONS: Similar rates of surgical success were observed with both implants at 5 years. The BGI produced greater IOP reduction and a lower rate of glaucoma reoperation than the AGV, but the BGI was associated with twice as many failures because of safety issues.

Longitudinal changes in peripapillary atrophy in the ocular hypertension treatment study: a case-control assessment.

PURPOSE: To explore the association between peripapillary atrophy (PPA) area and conversion from ocular hypertension (OHT) to glaucoma. DESIGN: Prospective, longitudinal cohort study of cases and controls. PARTICIPANTS: We included 279 age-matched and follow-up time-matched eyes with OHT that converted to glaucoma and 279 eyes with OHT that did not convert to glaucoma. METHODS: Initial and last acceptable optic disc photos were analyzed. Disc, α-zone, and ß-zone PPA were traced independently by 2 trained readers and their areas were measured with Photoshop. The α-zone and ß-zone areas were expressed as a percentage of optic disc area. MAIN OUTCOME MEASURES: α-Zone and ß-zone PPA size over time. RESULTS: Intraclass correlation coefficients (ICCs) demonstrated that readers had good agreement on disc area (ICC = 0.97) and ß-zone (ICC = 0.82), but not α-zone (ICC = 0.48). The ß-zone, as a percentage of disc area, increased in size (P < 0.001) in both eyes with incident primary open-angle glaucoma (mean, 10.6%; standard deviation, 22.6%) and matched controls (mean, 10.1%; standard deviation, 33.7) over follow-up (mean, 12.3 years). The increase in size did not differ between cases and controls (P = 0.82). Enlargement of the ß-zone was not correlated with follow-up time (P = 0.39). CONCLUSIONS: The results did not show a difference in size of the ß-zone at baseline between eyes that proceed to develop glaucoma and those that do not. Moreover, the ß-zone enlarges equally in case and control eyes during follow-up.

Three-year treatment outcomes in the Ahmed Baerveldt comparison study.

PURPOSE: To compare 3-year outcomes and complications of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt Glaucoma Implant (BGI) 101-350 (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. DESIGN: Multicenter, randomized, controlled clinical trial. PARTICIPANTS: A total of 276 patients: 143 in the AGV group and 133 in the BGI group. METHODS: Patients aged 18 to 85 years with refractory glaucoma and intraocular pressures (IOPs) ≥ 18 mmHg in whom an aqueous shunt was planned were randomized to an AGV or a BGI. MAIN OUTCOME MEASURES: The IOP, visual acuity (VA), supplemental medical therapy, complications, and failure (IOP >21 mmHg or not reduced by 20% from baseline, IOP <5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision). RESULTS: At 3 years, IOP (mean ± standard deviation) was 14.3 ± ± 4.7 mmHg (AGV group) and 13.1 ± 4.5 mmHg (BGI group) (P = 0.086) on 2.0 ± 1.4 and 1.5 ± 1.4 glaucoma medications, respectively (P = 0.020). The cumulative probabilities of failure were 31.3% (standard error [SE], 4.0%) (AGV) and 32.3% (4.2%) (BGI) (P = 0.99). Postoperative complications associated with reoperation or vision loss of >2 Snellen lines occurred in 24 patients (22%) (AGV) and 38 patients (36%) (BGI) (P = 0.035). The mean change in the logarithm of the minimum angle of resolution VA at 3 years was similar (AGV: 0.21 ± 0.88, BGI: 0.26 ± 0.74) in the 2 treatment groups at 3 years (P = 0.66). The cumulative proportion of patients (SE) undergoing reoperation for glaucoma before the 3-year postoperative time point was 14.5% (3.0%) in the AGV group compared with 7.6% (2.4%) in the BGI group (P = 0.053, log rank). The relative risk of reoperation for glaucoma in the AGV group was 2.1 times that of the BGI group (95% confidence interval, 1.0-4.8; P = 0.045, Cox proportional hazards regression). CONCLUSIONS: Implantation of the AGV was associated with the need for significantly greater adjunctive medication to achieve equal success relative to implantation of the BGI and resulted in a greater relative risk of reoperation for glaucoma. More subjects experienced serious postoperative complications in the BGI group than in the AGV group.

Ventriculoperitoneal shunt as a treatment of visual loss in idiopathic intracranial hypertension.

BACKGROUND: The aims of this study were to evaluate visual function outcomes in idiopathic intracranial hypertension (IIH) patients who underwent ventriculoperitoneal (VP) shunt for visual loss and to determine a VP shunt survival curve over time. METHODS: A retrospective medical record review was performed of all new IIH patients first evaluated at our institution who underwent VP shunt placement over a 7-year period (2004-2010). There were 2 primary outcome measures: the first being visual acuity (VA) and the second being shunt survival. Patients who received VP shunt for visual loss were included in the visual outcome analysis, and all patients who received VP shunt for any reason were included in the shunt survival analysis. RESULTS: Of the 338 new patients with IIH, 19 patients (6%) met the inclusion criteria and 17 underwent VP shunt for visual loss and 2 for headaches. Average follow-up was 21.2 months (range, 5-1,342 days). Of the 17 patients who had VP shunt for visual loss, 5 patients had optic nerve sheath fenestration (ONSF) surgery before VP shunt, and 1 patient had bilateral ONSF surgery after VP shunt. Median VA before shunt was 20/200 in the worse eye (range, 20/20 to NLP) and 20/40 in the better eye (20/20 to HM). Median VA after shunt was 20/60 in the worse eye (20/20 to lumboperitoneal) and 20/30 in the better eye (20/20 to 20/800). The improvement in VA was statistically significant in both worse eyes (P = 0.002, Wilcoxon signed-rank test) and better eyes (P = 0.028). The mean automated visual field (AVF) mean deviation (MD) of available AVFs before shunt was 223.36 dB (range, 233.38 to 27.01 dB) for the worse eye (n = 11) and 219.66 dB (230.11 to 25.91 dB) for the better eye (n = 11). Mean AVF MD deviation of available AVFs after shunt was 220.68 dB (232.13 to 23.97 dB) for the worse eye (n = 11) and 216.35 dB (232.13 to 21.00 dB) for the better eye (n = 11): this improvement was not significant (P = 0.27, P = 0.26, respectively). Independent masked record reviews by 3 neuro-ophthalmologists showed that 9 (53%) patients improved, 5 (29%) unchanged, 1 (6%) worsened, and 2 (12%) were indeterminate. Kaplan-Meier analysis showed a persistent steady decrease of functioning VP shunts over the entire period of 36 months with 80%, 65%, and 48% of VP shunts functioning without replacement, removal, or revision at 12, 24, and 36 months, respectively. CONCLUSION: VP shunts improve or stabilize most IIH patients presenting with severe progressive visual loss or those with visual loss refractive to medical treatment and ONSF. Survival analysis shows persistent decrease of functioning shunts over time.

Characterization of a clinician-scientist cohort in ophthalmology: a demographic analysis of k grant awardees in ophthalmology.

OBJECTIVE: To analyze ophthalmologists who are National Institutes of Health (NIH) K grant awardees to characterize clinician-scientists in ophthalmology. DESIGN: Cohort study. PARTICIPANTS: Ophthalmologists who have received a K award from 1996 through 2010. METHODS: K08 and K23 grant awardees were identified through the NIH Research Portfolio Online Reporter database. Information including gender, institution, educational degrees, and success in obtaining an R01 grant was analyzed. MAIN OUTCOME MEASURES: Receipt of an R01 grant. RESULTS: One hundred five ophthalmologists were identified who received K08 or K23 grants from the National Eye Institute from 1996 through 2010. Overall, 75% of these were male, although 43% of K awardees were women from 2006 through 2010. Sixty-five percent (68/105) of individuals came from ophthalmology departments that ranked in the top 20 of NIH funding in 2010. The most predominant subspecialties represented were retina (32%), cornea (22%), and glaucoma (15%). Among the K awardees, 40% (42/105) had a doctor of philosophy (PhD) degree in addition to their medical doctor degree. From 1996 through 2000, 61% (23/38) were successful in obtaining an R01 grant, whereas only 13% (5/39) from 2001 through 2005 obtained R01 grants (P<0.001). CONCLUSIONS: Gender disparities exist among K awardees in ophthalmology, but these seem to be improving over time. None of the other variables studied-gender, PhD degree, specialty, or funding tier-was associated with obtaining R01 funding. This study helps to characterize the clinician-scientist cohort in ophthalmology and to identify areas to improve the recruitment of these individuals. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

The Tube Versus Trabeculectomy Study: interpretation of results and application to clinical practice.

PURPOSE OF REVIEW: The Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube-shunt surgery to trabeculectomy with mitomycin C (MMC) in eyes with previous cataract and/or failed glaucoma surgery. This article interprets results from the TVT Study and applies them to clinical practice. RECENT FINDINGS: Both tube-shunt surgery and trabeculectomy with MMC produced intraocular pressure (IOP) reduction to the low teens throughout the 5-year duration of the study. Tube-shunt surgery was associated with use of more glaucoma medications than trabeculectomy with MMC during the first 2 years of the study, but medical therapy equalized with longer follow-up. Trabeculectomy with MMC had higher rates of surgical failure and reoperation for glaucoma compared with tube-shunt surgery. Vision loss occurred at a similar rate with the two surgical procedures. Early complications were more frequent after trabeculectomy with MMC relative to tube-shunt surgery, but both procedures had similar rates of late postoperative complications and serious complications. SUMMARY: Tube-shunt surgery and trabeculectomy with MMC are both viable surgical options for managing glaucoma in patients who have undergone prior cataract and/or failed filtering surgery. Results of the TVT Study support the expanding use of tube shunts beyond refractory glaucomas.

Comparison of automated analysis of Cirrus HD OCT spectral-domain optical coherence tomography with stereo photographs of the optic disc.

OBJECTIVE: To evaluate a new automated analysis of optic disc images obtained by spectral-domain optical coherence tomography (SD OCT). Areas of the optic disc, cup, and neural rim in SD OCT images were compared with these areas from stereoscopic photographs to represent the current traditional optic nerve evaluation. The repeatability of measurements by each method was determined and compared. DESIGN: Evaluation of diagnostic technology. PARTICIPANTS: One hundred nineteen healthy eyes, 23 eyes with glaucoma, and 7 glaucoma suspect eyes. METHODS: Optic disc and cup margins were traced from stereoscopic photographs by 3 individuals independently. Optic disc margins and rim widths were determined automatically in SD OCT. A subset of photographs was examined and traced a second time, and duplicate SD OCT images also were analyzed. MAIN OUTCOME MEASURES: Agreement among photograph readers, between duplicate readings, and between SD OCT and photographs were quantified by the intraclass correlation coefficient (ICC), by the root mean square, and by the standard deviation of the differences. RESULTS: Optic disc areas tended to be slightly larger when judged in photographs than by SD OCT, whereas cup areas were similar. Cup and optic disc areas showed good correlation (0.8) between the average photographic reading and SD OCT, but only fair correlation of rim areas (0.4). The SD OCT was highly reproducible (ICC, 0.96-0.99). Each reader also was consistent with himself on duplicate readings of 21 photographs (ICC, 0.80-0.88 for rim area and 0.95-0.98 for all other measurements), but reproducibility was not as good as SD OCT. Measurements derived from SD OCT did not differ from photographic readings more than the readings of photographs by different readers differed from each other. CONCLUSIONS: Designation of the cup and optic disc boundaries by an automated analysis of SD OCT was within the range of variable designations by different readers from color stereoscopic photographs, but use of different landmarks typically made the designation of the optic disc size somewhat smaller in the automated analysis. There was better repeatability among measurements from SD OCT than from among readers of photographs. The repeatability of automated measurement of SD OCT images is promising for use both in diagnosis and in monitoring of progression.

The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

PURPOSE: The Ahmed Baerveldt Comparison (ABC) Study compares the long-term outcomes and complications of the Ahmed glaucoma valve (AGV; model FP7; New World Medical, Los Ranchos, CA) and the Baerveldt glaucoma implant (BGI; model 101-350; Abbott Medical Optics, Abbott Park, IL). DESIGN: Multicenter, randomized, controlled clinical trial. PARTICIPANTS: Two hundred seventy-six glaucoma patients at 16 clinical centers worldwide who were 18 to 85 years of age with inadequately controlled intraocular pressure (IOP; ≥18 mmHg) in whom placement of an aqueous shunt was planned. METHODS: Study patients were randomized to undergo implantation of an AGV or a BGI. MAIN OUTCOME MEASURES: Failure, defined as IOP >21 mmHg or not reduced by 20% less than baseline or IOP ≤5 mmHg (2 consecutive visits after 3 months), additional glaucoma surgery, removal of the implant, or loss of light perception vision. RESULTS: A total of 276 patients were enrolled between October 2006 and April 2008, including 143 in the AGV group and 133 in the BGI group. The mean age±standard deviation (SD) of patients enrolled was 63±14 years, and 52% were male. The mean baseline IOP±SD was 31.5±11.8 mmHg. Except for a 13% higher prevalence of hypertension in the AGV group, no significant differences in baseline demographic or ocular characteristics were observed between the study groups. Intraoperative complications occurred in 11 (8%) patients in the AGV group and in 16 (12%) patients in the BGI group (P = 0.31). CONCLUSIONS: The ABC Study should yield valuable prospective data comparing 2 commonly used aqueous shunts in clinical practice.

Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up.

PURPOSE: To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma. DESIGN: Multicenter, randomized, controlled clinical trial. PARTICIPANTS: Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. METHODS: Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications. RESULTS: Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group (P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group (P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group (P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year (P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group (P = 0.014). CONCLUSIONS: Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI.

Treating uncorrected refractive error in adults in the developing world with autorefractors and ready-made spectacles.

BACKGROUND: To evaluate a method for treating uncorrected refractive error in adults in the developing world. DESIGN: Prospective, cross-sectional study in outpatient community health centres. PARTICIPANTS: Eight hundred and forty subjects aged 18 and older from rural villages in Haiti and Belize. METHODS: Undilated refractive error screening exams were conducted over a 5-day period in rural Haiti and Belize using portable autorefractors. Isometropic, spherical, ready-made spectacles were provided to patients with bilateral refractive error, astigmatism ≤ 1 dioptre in each eye and visual acuity worse than 6/9 in each eye. Visual acuity was measured with and without corrective spectacles. MAIN OUTCOME MEASURES: The mean visual improvement and median final visual acuity after treatment with ready-made glasses. RESULTS: Eight hundred and forty patients aged 18 and older were screened with autorefractors. One hundred and eighty-nine subjects (22.5%) were found to have visually significant bilateral refractive error. Fifty-eight per cent (110/189) of these patients met criteria for treatment with ready-made spectacles. Visual acuity improved an average of 4.2 lines in the better eye and 4.1 lines in the worse eye with corrective glasses. The median visual acuity in the better eye was 6/6 after treatment. CONCLUSION: Autorefractors and ready-made spectacles allow for effective treatment of uncorrected refractive error in adults in the developing world.

Relationship between central corneal thickness and hypotony-related complications after glaucoma surgery.

BACKGROUND AND OBJECTIVE: To examine the hypothesis that patients with increased central corneal thickness may have an overestimation of Goldmann applanation tension and a predisposition to hypotony-related complications. PATIENTS AND METHODS: A case-control analysis of patients with an intraocular pressure of 7 mm Hg or less on two consecutive postoperative visits following glaucoma filtration or drainage implant surgery was performed. Forward stepwise multiple logistic regression was used to determine the model that best predicted hypotony-related complications defined as choroidal effusion or hypotony maculopathy. RESULTS: Forty-three eyes (17 with hypotony-related complications and 26 controls) of 43 patients were enrolled. Eyes with pseudophakia (P = .006) and lower postoperative intraocular pressure (P = .013) were significantly more likely to develop hypotony-related complications. Mean central corneal thickness was similar in eyes with hypotony-related complications (519 +/- 32 microm) and controls (525 +/- 37 microm) and was not a significant predictor of hypotony-related complications in the multivariate model (P = .90). CONCLUSION: Increased central corneal thickness does not represent a risk factor for hypotony-related complications following glaucoma surgery.

Utilization of Ophthalmology-Specific Emergency Department Services.

OBJECTIVE: To describe utilization trends of an ophthalmology-specific emergency department (ED). METHODS: Prospective cohort study of new patients presenting in the ophthalmology ED for at least a 30-day period in the spring of each year for five consecutive years (2010-14) at a university referral center. A data form, including information about the ED visit and patient demographics, was included in each patient chart. Data were analyzed with Pearson chi-square test and multiple logistic regression. RESULTS: A total of 5323 chart data forms were completed. An average of 42.2 new patients per day presented to the ophthalmology ED. Most common diagnoses were viral conjunctivitis (8.7%), dry eye syndrome (6.6%), and corneal abrasion (6.6%). Non-emergent visits accounted for 35.8% of surveys completed. Factors associated with non-emergent visits included female gender, age 65 years or older, weekday visits, and patient symptom duration greater than one week (p < 0.0001 for each factor). When compared to all other insurance categories combined, patients who were members of the regional public assistance program were the most likely to present with a non-emergency (48.5% versus 34.9%, p < 0.001), while Workers' Compensation patients were least likely to present with a non-emergency (16% versus 36.5%, p < 0.001). CONCLUSIONS: Over one-third of new patient visits were non-emergent. Factors predictive of non-emergent patient visits were female gender, age 65 years or older, duration of symptoms greater than one week, weekday visits, and the form of insurance coverage.

Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up.

PURPOSE: To report one-year results of the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. SETTING: 17 Clinical Centers. STUDY POPULATION: Patients 18 to 85 years of age who had previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure (IOP) > or =18 mm Hg and < or =40 mm Hg on maximum tolerated medical therapy. INTERVENTIONS: 350 mm(2) Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). MAIN OUTCOME MEASURES: IOP, visual acuity, and reoperation for glaucoma. RESULTS: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At one year, IOP (mean +/- SD) was 12.4 +/- 3.9 mm Hg in the tube group and 12.7 +/- 5.8 mm Hg in the trabeculectomy group (P = .73). The number of glaucoma medications (mean +/- SD) was 1.3 +/- 1.3 in the tube group and 0.5 +/- 0.9 in the trabeculectomy group (P < .001). The cumulative probability of failure during the first year of follow-up was 3.9% in the tube group and 13.5% in the trabeculectomy group (P = .017). CONCLUSIONS: Nonvalved tube shunt surgery was more likely to maintain IOP control and avoid persistent hypotony or reoperation for glaucoma than trabeculectomy with MMC during the first year of follow-up in the TVT Study. Both surgical procedures produced similar IOP reduction at one year, but there was less need for supplemental medical therapy following trabeculectomy with MMC.

Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up.

PURPOSE: To describe the intraoperative and postoperative complications encountered during the first year of follow-up in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. SETTING: Seventeen clinical centers. STUDY POPULATION: Two hundred twelve patients aged 18 to 85 years who had undergone previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure > or =18 mm Hg and < or =40 mm Hg on maximum tolerated medical therapy. INTERVENTIONS: A 350-mm(2) Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). MAIN OUTCOME MEASURES: Surgical complications, reoperation for complications, visual acuity, and cataract progression. RESULTS: Intraoperative complications occurred in seven patients (7%) in the tube group and 10 patients (10%) in the trabeculectomy group (P = .59). Postoperative complications developed in 36 patients (34%) in the tube group and 60 patients (57%) in the trabeculectomy group during the first year of follow-up (P = .001). Surgical complications were associated with reoperation and/or loss of > or =2 lines of Snellen visual acuity in 18 patients (17%) in the tube group and 28 patients (27%) in the trabeculectomy group (P = .12). CONCLUSIONS: There were a large number of surgical complications during the first year of follow-up in the study, but most were self-limited. The incidence of postoperative complications was higher after trabeculectomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures.