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.

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.

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.

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.

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.

Adverse vitreoretinal outcomes of glaucoma drainage devices based on verified and unverified financial claims data.

BACKGROUND AND OBJECTIVE: To determine adverse vitreoretinal outcome rates after glaucoma drainage device (GDD) surgery. PATIENTS AND METHODS: Medical records from the Anne Bates Leach Eye Hospital with financial claims from 1991 to 2005 for GDD surgery coded for endophthalmitis, choroidal hemorrhage, or retinal detachment were reviewed. Cumulative incidences were calculated before and after verifying claims with chart review. RESULTS: GDD surgery was performed in 2,661 eyes. Thirty-three cases of endophthalmitis were identified, with 10 attributable to GDD (1-, 5-, and 10-year cumulative incidences: 0.22%, 0.43%, and 0.83%, respectively). Forty cases of choroidal hemorrhage were identified, with 20 attributable to GDD (1-, 5-, and 10-year incidences: 0.81% for all time points). Rhegmatogenous retinal detachments developed in 148 eyes, with 42 attributable to GDD (1-, 5-, and 10-year incidences: 1.25%, 2.02%, and 2.67%, respectively). CONCLUSION: This study's complication rates compare favorably with those previously reported. The use of claims data without chart review verification may result in overestimated event rates.

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.

Dilated eye examination screening guideline compliance among patients with diabetes without a diabetic retinopathy diagnosis: the role of geographic access.

OBJECTIVE: To estimate the prevalence of, and factors associated with, dilated eye examination guideline compliance among patients with diabetes mellitus (DM), but without diabetic retinopathy. RESEARCH DESIGN AND METHODS: Utilizing the computerized billing records database, we identified patients with International Classification of Diseases (ICD)-9 diagnoses of DM, but without any ocular diagnoses. The available medical records of patients in 2007-2008 were reviewed for demographic and ocular information, including visits through 2010 (n=200). Patients were considered guideline compliant if they returned at least every 15 months for screening. Participant street addresses were assigned latitude and longitude coordinates to assess their neighborhood socioeconomic status (using the 2000 US census data), distance to the screening facility, and public transportation access. Patients not compliant, based on the medical record review, were contacted by phone or mail and asked to complete a follow-up survey to determine if screening took place at other locations. RESULTS: The overall screening compliance rate was 31%. Patient sociodemographic characteristics, insurance status, and neighborhood socioeconomic measures were not significantly associated with compliance. However, in separate multivariable logistic regression models, those living eight or more miles from the screening facility were significantly less likely to be compliant relative to those living within eight miles (OR=0.36 (95% CI 0.14 to 0.86)), while public transit access quality was positively associated with screening compliance (1.34 (1.07 to 1.68)). CONCLUSIONS: Less than one-third of patients returned for diabetic retinopathy screening at least every 15 months, with transportation challenges associated with noncompliance. Our results suggest that reducing transportation barriers or utilizing community-based screening strategies may improve compliance.

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.

Outcomes of glaucoma reoperations in the Tube Versus Trabeculectomy (TVT) Study.

PURPOSE: To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Cohort study of patients in a multicenter randomized clinical trial. METHODS: The TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. Randomization assigned 107 patients to surgery with a tube shunt (350 mm(2) Baerveldt glaucoma implant) and 105 patients to trabeculectomy with mitomycin C (0.4 mg/mL for 4 minutes). Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery. Outcome measures included intraocular pressure (IOP), use of glaucoma medications, visual acuity, surgical complications, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, additional glaucoma surgery, or loss of light perception vision). RESULTS: Additional glaucoma surgery was performed in 8 patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study, and the 5-year cumulative reoperation rate was 9% in the tube group and 29% in the trabeculectomy group (P = .025). Follow-up (mean ± SD) after additional glaucoma surgery was 28.0 ± 16.0 months in the tube group and 30.5 ± 20.4 months in the trabeculectomy group (P = .76). At 2 years after a glaucoma reoperation, IOP (mean ± SD) was 15.0 ± 5.5 mm Hg in the tube group and 14.4 ± 6.6 mm Hg in the trabeculectomy group (P = .84). The number of glaucoma medications (mean ± SD) after 2 years of follow-up was 1.1 ± 1.3 in the tube group and 1.4 ± 1.4 in the trabeculectomy group (P = .71). The cumulative probability of failure at 1, 2, 3, and 4 years after additional glaucoma surgery was 0%, 43%, 43%, and 43%, respectively, in the tube group, and 0%, 9%, 20%, and 47% in the trabeculectomy group (P = .28). Reoperations to manage complications were required in 1 patient in the tube group and 5 patients in the trabeculectomy group (P = .63). CONCLUSIONS: The rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin C than tube shunt surgery in the TVT Study. Similar surgical outcomes were observed after additional glaucoma surgery, irrespective of initial randomized treatment in the study.

Trial end points and natural history in patients with G11778A Leber hereditary optic neuropathy : preparation for gene therapy clinical trial.

IMPORTANCE Establishing the natural history of G11778A Leber hereditary optic neuropathy (LHON) is important to determine the optimal end points to assess the safety and efficacy of a planned gene therapy trial. OBJECTIVE To use the results of the present natural history study of patients with G11778A LHON to plan a gene therapy clinical trial that will use allotopic expression by delivering a normal nuclear-encoded ND4 gene into the nuclei of retinal ganglion cells via an adeno-associated virus vector injected into the vitreous. DESIGN, SETTING, AND PARTICIPANTS A prospective observational study initiated in 2008 was conducted in primary and referral institutional practice settings. Participants included 44 individuals with G11778A LHON, recruited between September 2008 and March 2012, who were evaluated every 6 months and returned for 1 or more follow-up visits (6-36 months) as of August 2012. EXPOSURES Complete neuro-ophthalmic examination and main measures. MAIN OUTCOMES AND MEASURES Visual acuity, automated visual field testing, pattern electroretinogram, and spectral-domain optical coherence tomography. RESULTS Clinical measures were stable during the follow-up period, and visual acuity was as good as or better than the other visual factors used for monitoring patients. Based on a criterion of 15 or more letters from the Early Treatment Diabetic Retinopathy Study chart, 13 eyes of 8 patients (18%) improved, but 24 months after the onset of symptoms, any further improvements were to no better than 20/100. Acuity recovery occurred in some patients despite continued marked retinal nerve fiber layer thinning indistinguishable from that in patients who did not recover visual acuity. CONCLUSIONS AND RELEVANCE Spontaneous improvement of visual acuity in patients with G11778A LHON is not common and is partial and limited when it occurs, so improvements in vision with adeno-associated virus-mediated gene therapy of a synthetic wild-type ND4 subunit gene should be possible to detect with a reasonable sample size. Visual acuity appears to be the most suitable primary end point for the planned clinical trial.

Ocular decompression with cotton swabs lowers intraocular pressure elevation after intravitreal injection.

OBJECTIVE: To determine the effect of preinjection ocular decompression by cotton swabs on the immediate rise in intraocular pressure (IOP) after intravitreal injections. METHODS: Forty-eight patients receiving 0.05 mL ranibizumab injections in a retina clinic were randomized to 2 anesthetic methods in each eye on the same day (if bilateral disease) or on consecutive visits (if unilateral disease). One method utilized cotton swabs soaked in 4% lidocaine applied to the globe with moderate pressure and the other 3.5% lidocaine gel applied without pressure. IOPs were recorded at baseline (before injection) and at 0, 5, 10, and 15 minutes after the injection until the IOP was ≤30 mm Hg. The IOP elevations from baseline were compared after the 2 anesthetic methods. RESULTS: The preinjection mean IOP (SD, mm Hg) was 15.5 (3.3) before the cotton swabs and 15.9 (3.0) before the gel (P=0.28). Mean IOP (SD, mm Hg) change immediately after injection was 25.7 (9.2) after the cotton swabs and 30.9 (9.9) after the gel (P=0.001). Thirty-five percent of gel eyes had IOP≥50 mm Hg compared with only 10% of cotton swab eyes immediately after the injection (P<0.001). CONCLUSION: Decompressing the eye with cotton swabs during anesthetic preparation before an intravitreal injection produces a significantly lower IOP spike after the injection.

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.

Randomized clinical trial of two anesthetic techniques for intravitreal injections: 4% liquid lidocaine on cotton swabs versus 3.5% lidocaine gel.

OBJECTIVE: To compare same-day and next-day pain control and safety of two anesthetic techniques utilizing 4% liquid lidocaine applied with sterile cotton swabs versus 3.5% lidocaine gel for intravitreal injections. Main outcome measures were: discomfort during anesthetic preparation and needle penetration, 1 and 24 h after injection. METHODS: Patients were randomized to alternate anesthetic method at two consecutive injections in one eye or in different eyes on the same day if requiring bilateral injections. Overall satisfaction, corneal staining, and subconjunctival hemorrhage (SCH) were compared. RESULTS: Fifty patients were enrolled. Both methods resulted in similar mild discomfort during anesthetic preparation, 1 and 24 h later. The gel resulted in slightly higher discomfort during needle penetration (p = 0.026). Patients were satisfied with both techniques (p = 0.91), however, 52% patients preferred gel, 33% were indifferent, and 15% preferred cotton swabs (p = 0.002). There were significantly less corneal staining (p = 0.001) and SCH (p = 0.004) after the gel. CONCLUSION: Both techniques are equally effective and yield mild discomfort scores during the procedure and the next day. The gel method results in significantly less ocular surface irritation.

Used glasses versus ready-made spectacles for the treatment of refractive error.

BACKGROUND AND OBJECTIVE: To compare visual outcomes for used glasses versus ready-made spectacles in the treatment of refractive error. PATIENTS AND METHODS: In this prospective, comparative case series, undilated refractive error screening examinations were conducted over a 5-week period. Patients with bilateral refractive error were treated with used glasses and ready-made spectacles powered to match their prescriptions. Snellen visual acuity was measured with no correction, best (manifest) correction, unrefined autorefraction, used glasses, and ready-made spectacles. Main outcome measurements were the mean visual improvement from uncorrected acuity and median final visual acuity after treatment with used and ready-made spectacles. RESULTS: One hundred forty-one patients ages 18 and older with bilateral refractive error were examined. Uncorrected visual acuity in each eye improved an average of 4.5 lines with best correction, 4.0 lines with used glasses, and 3.5 lines with ready-made spectacles, with used glasses demonstrating a statistically significant advantage over ready-made spectacles (P < .001). The median visual acuity in the better eye improved from 20/60 uncorrected to 20/25 with all types of glasses. In patients with less than 1 diopter of anisometropia and greater than 1 diopter of astigmatism in each eye (49%), the ready-made spectacles performed equally as well as the used glasses (P = .95), improving vision an average of 3.9 lines for a median final visual acuity of 20/25 in the better eye. CONCLUSION: Although both were effective, used glasses are better than ready-made spectacles for improving vision loss due to refractive error.

Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up.

PURPOSE: To report 5-year treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. SETTINGS: Seventeen 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) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. INTERVENTIONS: Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C ([MMC]; 0.4 mg/mL for 4 minutes). MAIN OUTCOME MEASURES: IOP, visual acuity, use of supplemental medical therapy, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, reoperation for glaucoma, or loss of light perception vision). RESULTS: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At 5 years, IOP (mean ± SD) was 14.4 ± 6.9 mm Hg in the tube group and 12.6 ± 5.9 mm Hg in the trabeculectomy group (P = .12). The number of glaucoma medications (mean ± SD) was 1.4 ± 1.3 in the tube group and 1.2 ± 1.5 in the trabeculectomy group (P = .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P = .002; hazard ratio = 2.15; 95% confidence interval = 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P = .025). CONCLUSIONS: Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement.

Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up.

PURPOSE: To describe postoperative complications encountered in the Tube Versus Trabeculectomy (TVT) Study during 5 years of follow-up. DESIGN: Multicenter randomized clinical trial. SETTINGS: Seventeen 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) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. INTERVENTIONS: Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC 0.4 mg/mL for 4 minutes). MAIN OUTCOME MEASURES: Surgical complications, reoperations for complications, visual acuity, and cataract progression. RESULTS: Early postoperative complications occurred in 22 patients (21%) in the tube group and 39 patients (37%) in the trabeculectomy group (P = .012). Late postoperative complications developed in 36 patients (34%) in the tube group and 38 patients (36%) in the trabeculectomy group during 5 years of follow-up (P = .81). The rate of reoperation for complications was 22% in the tube group and 18% in the trabeculectomy group (P = .29). Cataract extraction was performed in 13 phakic eyes (54%) in the tube group and 9 phakic eyes (43%) in the trabeculectomy group (P = .43). CONCLUSIONS: A large number of surgical complications were observed in the TVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than tube shunt surgery. The rates of late postoperative complications, reoperation for complications, and cataract extraction were similar with both surgical procedures after 5 years of follow-up.