C Gustavo De Moraes

Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma.

ABSTRACT Glaucomatous visual field progression has both personal and societal costs and therefore has a serious impact on quality of life. At the present time, intraocular pressure (IOP) is considered to be the most important modifiable risk factor for glaucoma onset and progression. Reduction of IOP has been repeatedly demonstrated to be an effective intervention across the spectrum of glaucoma, regardless of subtype or disease stage. In the setting of approval of IOP‐lowering therapies, it is expected that effects on IOP will translate into benefits in long‐term patient‐reported outcomes. Nonetheless, the effect of these medications on IOP and their associated risks can be consistently and objectively measured. This helps to explain why regulatory approval of new therapies in glaucoma has historically used IOP as the outcome variable. Although all approved treatments for glaucoma involve IOP reduction, patients frequently continue to progress despite treatment. It would therefore be beneficial to develop treatments that preserve visual function through mechanisms other than lowering IOP. The United States Food and Drug Administration (FDA) has stated that they will accept a clinically meaningful definition of visual field progression using Glaucoma Change Probability criteria. Nonetheless, these criteria do not take into account the time (and hence, the speed) needed to reach significant change. In this paper we provide an analysis based on the existing literature to support the hypothesis that decreasing the rate of visual field progression by 30% in a trial lasting 12–18 months is clinically meaningful. We demonstrate that a 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health‐related quality of life, as defined by validated instruments designed to measure that endpoint. HIGHLIGHTSA 30% decrease in rate of visual field progression can be projected to have a significant effect on health‐related quality of life.The US FDA definition of clinically‐meaningful progression corresponds to a slope ≤−0.5 dB/yr in ≥5 abnormal test locations.A 30% decrease in visual field progression with trend analysis is equivalent to a 2–3 mmHg decrease in intraocular pressure.

Intraocular Pressure Rise in Subjects with and without Glaucoma during Four Common Yoga Positions

Purpose To measure changes in intraocular pressure (IOP) in association with yoga exercises with a head-down position. Methods The single Center, prospective, observational study included 10 subjects with primary open-angle glaucoma and 10 normal individuals, who performed the yoga exercises of Adho Mukha Svanasana, Uttanasana, Halasana and Viparita Karani for two minutes each. IOP was measured by pneumatonometry at baseline and during and after the exercises. Results All yoga poses were associated with a significant (P<0.01) rise in IOP within one minute after assuming the yoga position. The highest IOP increase (P<0.01) was measured in the Adho Mukha Svanasana position (IOP increase from 17±3.2 mmHg to 28±3.8 mmHg in glaucoma patients; from 17±2.8 mmHg to 29±3.9 mmHg in normal individuals), followed by the Uttanasana position (17±3.9 mmHg to 27±3.4 mmHg (glaucoma patients) and from 18±2.5 mmHg to 26±3.6 mmHg normal individuals)), the Halasana position (18±2.8 mmHg to 24±3.5 mmHg (glaucoma patients); 18±2.7 mmHg to 22±3.4 mmHg (normal individuals)), and finally the Viparita Kirani position (17±4 mmHg to 21±3.6 mmHg (glaucoma patients); 17±2.8 to 21±2.4 mmHg (normal individuals)). IOP dropped back to baseline values within two minutes after returning to a sitting position. Overall, IOP rise was not significantly different between glaucoma and normal subjects (P = 0.813), all though glaucoma eyes tended to have measurements 2 mm Hg higher on average. Conclusions Yoga exercises with head-down positions were associated with a rapid rise in IOP in glaucoma and healthy eyes. IOP returned to baseline values within 2 minutes. Future studies are warranted addressing whether yoga exercise associated IOP changes are associated with similar changes in cerebrospinal fluid pressure and whether they increase the risk of glaucoma progression. Trial Registration ClinicalTrials.gov #NCT01915680

Reproducibility of the water drinking test in treated glaucomatous patients

To evaluate the reproducibility of intraocular pressure peaks and fluctuation elicited during the water drinking test in treated glaucomatous patients with a long follow‐up interval.

Comparative Cost-effectiveness of the Baerveldt Implant, Trabeculectomy With Mitomycin, and Medical Treatment.

IMPORTANCE The Tube vs Trabeculectomy Trial (TVT) found that the 350-mm2 Baerveldt implant (tube) and trabeculectomy with mitomycin may be similarly effective in lowering intraocular pressure in primary open-angle glaucoma. However, to date, there are no published long-term clinical data on the cost-effectiveness of trabeculectomy with mitomycin vs tube insertion. OBJECTIVE To assess the cost-effectiveness of these procedures compared with maximal medical treatment. DESIGN, SETTING, AND PARTICIPANTS We used the Markov cohort model with a 5-year time horizon to study a hypothetical cohort of 100 000 patients who required glaucoma surgery. MAIN OUTCOMES AND MEASURES Quality-adjusted life-years (QALYs) gained, costs from the societal perspective, and the incremental cost-effectiveness ratio of medical treatment, trabeculectomy, and tube insertion. Costs were identified from Medicare Current Procedural Terminology and Ambulatory Payment Classification reimbursement codes and Red Book medication costs. The QALYs were based on visual field and visual acuity outcomes. The hypothetical societal limit to resources was included using a willingness-to-pay threshold of

Cost-Related Medication Nonadherence and Cost-Saving Behaviors Among Patients With Glaucoma Before and After the Implementation of Medicare Part D

50 000 per QALY. Costs and utilities were discounted at 3% per year. Uncertainty was assessed using deterministic sensitivity analyses. RESULTS The mean costs for medical treatment, trabeculectomy, and tube insertion were

Management of advanced glaucoma: Characterization and monitoring

6172,

Association of Glaucoma-Related, Optical Coherence Tomography–Measured Macular Damage With Vision-Related Quality of Life

7872 and

Corrigendum: Optic neuropathy and congenital glaucoma associated with probable Zika virus infection in Venezuelan patients

10 075, respectively; these amounts resulted in a cost difference of

β-Zone Parapapillary Atrophy and Rates of Glaucomatous Visual Field Progression: African Descent and Glaucoma Evaluation Study

1700 (95% CI,

Non-congenital severe ocular complications of Zika virus infection

1644-