Results from the Primary Tube Versus Trabeculectomy Study and translation to clinical practice.

PURPOSE OF REVIEW: The Primary Tube Versus Trabeculectomy (PTVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery and trabeculectomy with mitomycin C (MMC) in eyes without previous incisional ocular surgery. This article reviews results from the PTVT Study and suggests how they may be translated to clinical practice. RECENT FINDINGS: Tube shunt surgery had a higher failure rate than trabeculectomy with MMC in the PTVT Study, and the difference was statistically significant at 1 year but not at 3 years and 5 years. Both surgical procedures reduced intraocular pressure (IOP) to the low teens throughout 5 years of follow-up. Mean IOPs were lower after trabeculectomy with MMC compared with tube shunt implantation, and the differences were statistically significant during the first postoperative year and at 3 years. The greater IOP reduction after trabeculectomy with MMC was achieved with significantly fewer glaucoma medications relative to tube shunt placement. Surgical complications were common in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was significantly higher after trabeculectomy with MMC than tube shunt surgery. The rates of late postoperative complications, cataract progression, and vision loss were similar with both surgical procedures. Serious complications producing vision loss and/or requiring a reoperation to manage the complication developed more frequently after trabeculectomy with MMC compared with tube shunt surgery, and the difference was statistically significant at 1 year but not at 3 years and 5 years postoperatively. SUMMARY: Tube shunt implantation and trabeculectomy with MMC are both viable surgical options for managing glaucoma in patients without previous incisional ocular surgery. Results from the PTVT Study support further expansion of tube shunt use beyond refractory glaucomas.

Prophylaxis with intraocular pressure lowering medication and glaucomatous progression in patients receiving intravitreal anti-VEGF therapy.

AIM: To investigate whether pretreatment with pressure-lowering medication prior to anti-vascular endothelial factor (VEGF) injections had an effect on glaucomatous progression in patients with preexisting glaucoma or ocular hypertension (OHT). METHODS: A total of 66 eyes from 54 patients with a preexisting diagnosis of glaucoma or OHT, treated with six or more anti-VEGF injections were selected for chart review. Primary outcome measures were rate of visual field loss in dB/year, rate of change in retinal nerve fiber layer (RNFL) thickness in microns/year, and need for additional glaucoma intervention. RESULTS: The number of eyes requiring additional glaucoma medication was 5 of 20 (25.0%) and 14 of 46 (30.4%) for the pretreated and non-pretreated groups, respectively. The number of eyes requiring glaucoma laser or surgery was 4 of 20 (20.0%) and 13 of 46 (28.3%) for the pretreated and non-pretreated groups, respectively. Estimated mean rate of pattern standard deviation decline was not significant in either group (P>0.073), with no difference between groups (P=0.332). Although both groups showed significant RNFL change from baseline (P<0.011), no difference was detected between groups (P=0.467). CONCLUSION: Pretreatment has no detectable effect on structural or functional glaucomatous progression. Patients receiving repeated injections may be at risk for glaucomatous complications requiring invasive intervention.

Effects of Intravitreal Anti-VEGF Therapy on Glaucoma-like Progression in Susceptible Eyes.

PRéCIS:: Intravitreal anti-vascular endothelial growth factor (VEGF) injections may accelerate glaucomatous change in patients with preexisting glaucoma or ocular hypertension (OHT). The safety of long-term injections in this specific population may be reflected in the need for additional glaucoma interventions. PURPOSE: The purpose of this study was to investigate whether repeated anti-VEGF injections accelerate structural and functional glaucomatous change in eyes with preexisting glaucoma or OHT. MATERIALS AND METHODS: This is a retrospective, observational study of injected and noninjected fellow eyes. A total of 28 patients with preexisting glaucoma or OHT, who received ≥6 unilateral anti-VEGF injections for concurrent neovascular retinal disease, were selected for chart review. Primary outcome measures were rate of visual field loss in dB/year, rate of change in retinal nerve fiber layer (RNFL) thickness in microns/year, and need for additional glaucoma medications, surgery, or laser. RESULTS: The number of eyes requiring additional glaucoma surgery or laser was 8 of 28 (28.6%) for the injected group and 2 of 28 (7.1%) for the noninjected group. A significantly greater proportion of injected eyes required invasive glaucoma intervention (P=0.034). Average rate of decline in mean deviation and change in pattern standard deviation were both significantly greater in injected eyes (P=0.029; P=0.019). Estimated mean rate of global retinal nerve fiber layer change was -4.27 µm/y for the injected group and -1.17 µm/y for the noninjected group and was significant only for injected eyes (P=0.014). Only the superior quadrant exhibited thinning that was significantly different between groups (P=0.030). CONCLUSIONS: Intravitreal injections were associated with accelerated functional and structural glaucoma-like change in susceptible eyes. Clinicians should assess the need for glaucoma medications or other interventions over the course of anti-VEGF therapy.

Primary Open-Angle Glaucoma Preferred Practice Pattern(®) Guidelines.

UNLABELLED: PRIMARY OPEN-ANGLE GLAUCOMA PREFERRED PRACTICE PATTERN® GUIDELINES: Evidence-based update of the Primary Open-Angle Glaucoma Preferred Practice Pattern® (PPP) guidelines, describing the diagnosis and management of patients with primary open-angle glaucoma with an algorithm for patient management and detailed recommendations for evaluation and treatment options.

Primary Angle Closure Preferred Practice Pattern(®) Guidelines.

UNLABELLED: PRIMARY ANGLE CLOSURE PREFERRED PRACTICE PATTERN® GUIDELINES: Evidence-based update of the Primary Angle Closure Preferred Practice Pattern® (PPP) guidelines, describing the diagnosis and management of patients with primary angle closure with detailed recommendations for evaluation and treatment options.

Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern(®) Guidelines.

UNLABELLED: COMPREHENSIVE ADULT MEDICAL EYE EVALUATION® PREFERRED PRACTICE PATTERN® GUIDELINES: Evidence-based update of the Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern® (PPP) guidelines, discussing the rationale and components of an ophthalmic evaluation for adult patients with and without risk factors.

Primary Open-Angle Glaucoma Suspect Preferred Practice Pattern(®) Guidelines.

UNLABELLED: PRIMARY OPEN-ANGLE GLAUCOMA SUSPECT PREFERRED PRACTICE PATTERN® GUIDELINES: Evidence-based update of the Primary Open-Angle Suspect Glaucoma Preferred Practice Pattern® (PPP) guidelines, describing the diagnosis and management of patients with primary open-angle glaucoma suspect with detailed recommendations for evaluation and treatment options.

Long-term intraocular pressure control and corneal graft survival in eyes with a pars plana Baerveldt implant and corneal transplant.

PURPOSE: To investigate long-term intraocular pressure (IOP) control and corneal graft survival in eyes with a valveless Baerveldt glaucoma drainage implant (GDI) through the pars plana (PP) and a penetrating keratoplasty (PK). METHODS: We reviewed the medical records of 48 patients (51 eyes) who underwent PP placement of a GDI and a PK between July 1996 and June 2006 at the University of Virginia. The GDI was inserted during the same operation as the PK in 26 eyes (51.0%). Glaucoma control was assessed by IOP and the need for further glaucoma medication or surgery. Corneal grafts were assessed for clarity. RESULTS: Mean follow-up was 38.4 months. IOP was successfully controlled in 88%, 85%, and 82% of eyes at 12, 24, and 48 months, respectively. Corneal grafts were clear in 89%, 67%, and 41% of eyes at 12, 24, and 48 months, respectively. Corneal graft failure was significantly higher in eyes with an anterior chamber intraocular lens (P

The Advanced Glaucoma Intervention Study (AGIS): 14. Distinguishing progression of glaucoma from visual field fluctuations.

PURPOSE: To determine the least worsening of a visual field (VF) and the least number of confirming tests needed to identify progression of glaucomatous VF defects. DESIGN: Cohort study of participants in a clinical trial. PARTICIPANTS: Seven hundred fifty-two eyes of 565 patients with advanced glaucoma. METHODS: Visual field tests were quantified with the Advanced Glaucoma Intervention Study (AGIS) VF defect score and the Humphrey Field Analyzer mean deviation (MD). Follow-up was 8 to 13 years. MAIN OUTCOME MEASURES: Two measures based on the AGIS VF defect score: (1) sustained decrease of VF (SDVF), a worsening from baseline by 2 (alternatively, 3 or 4) or more units and sustained for 2 (alternatively, 3) consecutive 6-month visits and (2) after the occurrence of SDVF, the average percent of eyes with worsening by 2 (alternatively, 3 or 4) or more units from baseline. Two similar measures based on MD. RESULTS: Based on the original AGIS criteria for SDVF (a worsening of 4 units in the AGIS score sustained during 3 consecutive 6-month visits), 31% of eyes had an SDVF. The percent of eyes with a sustained event increases by approximately 10% when either the minimum number of units of field loss or the minimum number of 6-month visits during which the loss is sustained decreases by 1. During 3 years of follow-up after a sustained event, a worsening of at least 2 units was found in 72% of eyes that had a 2-visit sustained event. The same worsening was found in 84% of eyes that had a 3-visit sustained event. Through the next 10 years after a sustained event, based on worsening of 2, 3, or 4 units at 2 or 3 consecutive tests, the loss reoccurred, on average, in >/=75% of study eyes. Results for MD are similar. CONCLUSIONS: In patients with advanced glaucoma, a single confirmatory test 6 months after a VF worsening indicates with at least 72% probability a persistent defect when the worsening is defined by at least 2 units of AGIS score or by at least 2 decibels of MD. When the number of confirmatory tests is increased from 1 to 2, the percentage of eyes that show a persistent defect increases from 72% to 84%.

The Advanced Glaucoma Intervention Study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results.

OBJECTIVE: To present for black and white patients with medically uncontrolled glaucoma 10-year results of treatment with 1 of 2 randomly assigned surgical intervention sequences. DESIGN: Randomized clinical trial. PARTICIPANTS: Three hundred thirty-two black patients (451 eyes) and 249 white patients (325 eyes). Eyes had glaucoma that could not be controlled with medications alone. METHODS: Eyes were randomly assigned to 1 of 2 sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) or trabeculectomy-ALT-trabeculectomy (TAT). Second and third interventions were offered after failure of the preceding intervention. Minimum required intraocular pressure (IOP) for intervention failure ranged upward from 18 mmHg, the value depending on whether recent optic disc or visual field (VF) deterioration occurred, and on the magnitude of the field defect. Patients were observed every 6 months, with total potential follow-up ranging from 8 years, 4 months to 13 years. MAIN OUTCOME MEASURES: The averages over follow-up of (1) the percentage of eyes having moderate loss of VF and (2) the percentage of eyes having moderate loss of visual acuity (VA). RESULTS: Race-treatment interactions in VF and VA loss are significant for the 2 main outcome measures; therefore, results of treatment sequence differences are presented by race. In black patients the average percent of eyes with VF loss was less in the ATT sequence than in the TAT sequence, a difference that is not statistically significant at any visit. In white patients, conversely, after 18 months the average percent of eyes with VF loss was less in the TAT sequence, a difference that increases and is statistically significant in years 8 to 10. In both black and white patients, the average percent of eyes with VA loss was less in the ATT sequence; this difference is statistically significant throughout 10 follow-up years in black patients and is statistically significant only for the first year in white patients. In both black and white patients, average IOP reductions were greater in the TAT sequence, though the TAT-ATT difference was substantially greater in white patients. In both black and white patients, first-intervention failure rates were substantially lower for trabeculectomy than for trabeculoplasty. Ten-year cumulative incidence of unilateral VF impairment comparable to legal blindness was modest in eyes of black (ATT 11.9%, TAT 18.5%) and white (ATT 9.9%, TAT 7.3%) patients. CONCLUSIONS: Although IOP was lowered in both sequences in black and white patients with medically uncontrolled glaucoma, long-term visual function outcomes were better for the ATT sequence in black patients and better for the TAT sequence in white patients.