Validation of a Standardized Home Visual Acuity Test for Teleophthalmology.

Purpose: The recent exponential growth in teleophthalmology has been limited in part by the lack of a validated method to measure visual acuity (VA) remotely. We investigated the validity of a self-administered Early Treatment Diabetic Retinopathy Study (ETDRS) home VA test. We hypothesized that a home VA test with a printout ETDRS chart is equivalent to a standard technician-administered VA test in clinic. Design: Prospective cohort study. Participants: Two hundred nine eyes from 108 patients who had a scheduled in-person outpatient ophthalmology clinic visit at an academic medical center. Methods: Enrolled patients were sent a .pdf document consisting of instructions and a printout ETDRS vision chart calibrated for 5 feet. Patients completed the VA test at home before the in-person appointment, where their VA was measured by an ophthalmic technician using a standard ETDRS chart. Survey questions about the ease of testing and barriers to completion were administered. For the bioequivalence test with a 5% nominal level, the 2 1-sided tests procedure was used, and an equivalent 90% confidence interval (CI) was constructed and compared with the prespecified 7-letter equivalence margin. Main Outcome Measures: The primary outcome was the mean adjusted letter score difference between the home and clinic tests. Secondary outcomes included the unadjusted letter difference, absolute letter difference, and survey question responses. Results: The mean adjusted VA letter score difference was 4.1 letters (90% CI, 3.2-4.9 letters), well within the 7-letter equivalence margin. Average unadjusted VA scores in clinic were 3.9 letters (90% CI, 3.1-4.7 letters) more than scores at home. The absolute difference was 5.2 letters (90% CI, 4.6-5.9 letters). Ninety-eight percent of patients agreed that the home test was easy to perform. Conclusions: An ETDRS VA test self-administered at home following a standardized protocol was equivalent to a standard technician-administered VA test in clinic in the examined population.

Three-Year Findings on Intraocular Pressure Changes in The Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study.

BACKGROUND AND OBJECTIVE: This paper reports 3-year intraocular pressure (IOP) outcomes of the Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) study. PATIENTS AND METHODS: The prospective, controlled, observational study included 80 eyes of 40 participants undergoing routine pars plana vitrectomy. Study patients underwent preoperative evaluation and multimodal testing of the study (surgical) and fellow (control) eye. This testing was repeated at 3 months postoperatively and then annually for 3 years. RESULTS: Thirty-two of 40 patients (80%) completed 3-year follow-up. At 3 years postoperatively, there was no difference in IOP measurements in surgical eyes overall from baseline (P = .36). Subgroup analysis of pseudophakic eyes at baseline showed a significant elevation in IOP from 14.3 mm Hg ± 2.9 mm Hg at baseline to 16.8 mm Hg ± 3.2 mm Hg at 3-year follow-up (P < .029). Fellow eyes did not experience a significant change from baseline. CONCLUSION: The authors' 3-year results show that IOP is consistently and significantly elevated in pseudophakic eyes compared to baseline following routine vitrectomy. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:371-376.].

Long-term intraocular pressure changes after femtosecond laser-assisted cataract surgery in healthy eyes and glaucomatous eyes.

PURPOSE: To examine the long-term effect of femtosecond laser-assisted cataract surgery on intraocular pressure (IOP) in healthy (control) and glaucomatous eyes. SETTING: University of Colorado, Aurora, Colorado, and Vanderbilt University, Nashville, Tennessee, USA. DESIGN: Retrospective case series. METHODS: The study comprised patients aged 18 to 89 years meeting the inclusion criteria. Combination procedures were excluded. The main outcome measure was the change in the mean IOP from baseline to postoperatively. RESULTS: Of the 504 eyes meeting the criteria, 278 were in the glaucoma/glaucoma suspect group and 226 in the control group. Both groups had an initial mean increase in IOP 1 day postoperatively (control: +2.0 mm Hg; 95% confidence interval [CI], 1.4-2.6; glaucoma/glaucoma suspect: +3.4 mm Hg; 95% CI, 2.5-4.2) (both P < .001). The increase was significantly higher in the glaucoma/glaucoma suspect group. The IOP returned to baseline levels at 1 week. At 1 month, both groups had a significant decrease in IOP that persisted until year 1 in the control group and through 3 years in the glaucoma group. The number of IOP medications was unchanged in the glaucoma group during follow-up. The glaucoma/glaucoma suspect group achieved significantly greater IOP lowering than the control group after 6 months. CONCLUSIONS: Control eyes and eyes with glaucoma had an initial mean IOP rise 1 day after femtosecond laser-assisted cataract surgery. This was followed by a significant decrease starting at 1 month. The reduction was sustained through 3 years in the glaucoma group.

The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes.

PURPOSE: To compare 2 frequently used aqueous shunts for the treatment of glaucoma. DESIGN: International, multicenter, randomized trial. PARTICIPANTS: Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. METHODS: Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. RESULTS: A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. CONCLUSIONS: Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group.

Outcomes Disparities between Black and White Populations in the Surgical Management of Glaucoma.

African descent is a well-documented risk factor for glaucoma development, progression, and medical and surgical failure. We reviewed the literature for evidence of outcomes disparities between Black and White populations after trabeculectomy, Ex-PRESS shunt, viscocanalostomy, canaloplasy, tube shunt, laser trabeculoplasty, and cyclophotocoagulation. There are reports of decreased surgical success in Black patients after trabeculectomy, Ex-PRESS shunt, tube-shunt, and canaloplasty. At this time, there is no strong evidence that any procedure is more effective for intraocular pressure control than standard trabeculectomy for Black patients. Furthermore, there is insufficient evidence to recommend any particular secondary intervention over another, despite differences in inflammation and bleb-dependence. There is a need for randomized, controlled trials to assess race as a risk factor for failure after non-penetrating filtration surgery (NPFS). There is also a need for data on the efficacy of minimally invasive glaucoma surgery (MIGS) in Black populations.

Psychometric properties of the Glaucoma Treatment Compliance Assessment Tool in a multicenter trial.

PURPOSE: To assess the psychometric properties of a new version of the Glaucoma Treatment Compliance Assessment Tool, a survey evaluating health behavior and glaucoma adherence using constructs from the Health Belief Model. DESIGN: Psychometric analysis. METHODS: We administered the 47-statement Glaucoma Treatment Compliance Assessment Tool to 201 participants who were using a single bottle of an ocular hypotensive agent, and objectively measured adherence with medication event monitoring system devices over 60 days. Adherence was the percentage of days with correctly timed bottle openings. We used principal components analysis to determine construct validity, Cronbach's alpha for internal consistency reliability, frequency analysis for floor and ceiling effects, and Spearman rho for test-retest reliability. We determined predictive validity using univariate and multiple regression. RESULTS: The mean (±SD, range) adherence percentage was 79.9% (±18.5%, 20.3%-100.0%). Principal component analysis loaded 24 questions into 6 components that were consistent with the Health Belief Model. All 6 components had Cronbach's alpha reliability between 0.601 and 0.797. No statements had floor or ceiling effects, and all statements had acceptable test-retest reliability. Multiple regression analysis showed 4 Health Belief Model statements, white race, older age, and married marital status to be associated with higher adherence (adjusted R(2) = 0.27, P < .001). CONCLUSIONS: The newest version of the Glaucoma Treatment Compliance Assessment Tool showed acceptable psychometric properties. With further refinement, clinicians and researchers could use it to examine factors related to adherence and measure improvement in adherence with a change in health behavior attitudes.

Suprachoroidal devices in glaucoma surgery.

While conventional glaucoma filtration surgery provides excellent intraocular pressure (IOP) lowering effect, this comes at the expense of significant risks. As the physiology of the suprachoroidal space has become better understood, its potential as a source for aqueous drainage has generated significant interest. This has resulted in the creation of several suprachoroidal glaucoma devices with excellent IOP lowering ability and a much more favorable side effect profile.

Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) study: twelve-month findings.

PURPOSE: To report 1-year outcomes of the Prospective Retinal and Optic Nerve Vitrectomy Evaluation study. DESIGN: Prospective, controlled, observational study. PARTICIPANTS: Eighty eyes of 40 participants undergoing pars plana vitrectomy for epiretinal membrane (ERM), macular hole (MH), or vitreous opacities. METHODS: Enrolled participants underwent baseline evaluation of the study (surgical) and fellow (control) eyes by a masked fellowship-trained glaucoma specialist; evaluation included intraocular pressure (IOP; Goldmann applanation and Tono-Pen), central corneal thickness, gonioscopy, and cup-to-disc ratio measurement. Baseline testing included bilateral color fundus and optic disc photography, fundus autofluorescence, automated perimetry, and optical coherence tomography (OCT) of the macula and optic nerve. Evaluations were repeated at 3 months and 1 year after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was changes in peripapillary retinal nerve fiber layer (pRNFL) thickness. Secondary outcomes included changes in macular thickness and IOP. RESULTS: Thirty-eight of 40 patients completed 1 year of follow-up. Mean visual acuity (VA) improved in study eyes from baseline (P = 0.003) but remained worse than fellow eyes (P<0.001). Study eyes had thinner inferior pRNFL thickness (114±16.8 µm) compared with fellow eyes (123±14.7 µm; P = 0.004). Mean IOP difference between study eyes and fellow eyes increased from baseline to 1 year. At 1 year, MH study eyes had higher mean IOP (16.0±3.7 mmHg) compared with fellow eyes (14.8±3.4 mmHg; P = 0.08). Mean IOP for pseudophakic study eyes increased from 14.5±3.2 mmHg at baseline to 16.0±2.8 mmHg at 1 year (P = 0.04). Central subfield thickness (CST) and cube volume decreased in study eyes at 1 year but remained greater than that of fellow eyes (P<0.05). Reduction in CST from baseline correlated with degree of VA improvement (P<0.05). Mean deviation (MD) improved in ERM study eyes at 1 year when compared with baseline (-2.2 vs. -4.0; P = 0.02) but remained worse than fellow eyes (-1.2; P = 0.002). CONCLUSIONS: One year after vitrectomy, VA, CST, and MD improved in study eyes but not to the level of fellow eyes. Inferior pRNFL thickness decreased in study eyes. Reduction in CST from baseline correlated with degree of VA improvement. Pseudophakic study eyes demonstrated increased IOP when compared with baseline.

Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) study: findings at 3 months.

BACKGROUND: The purpose of this paper is to report the 3-month findings of the Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) study. METHODS: Eighty eyes of 40 participants undergoing vitrectomy were enrolled. Participants underwent baseline evaluation of the study (surgical) and fellow (control) eye that included: intraocular pressure, central corneal thickness, gonioscopy, cup-to-disc ratio measurement, color fundus and optic disc photography, automated perimetry, and optical coherence tomography of the macula and optic nerve. Evaluation was repeated at 3 months. Main outcome measures were changes in macula and retinal nerve fiber layer (RNFL) thickness and intraocular pressure. RESULTS: All participants completed follow-up. Mean cup-to-disc ratio of study and fellow eyes at baseline was 0.43 ± 0.2 and 0.46 ± 0.2, respectively, and 13% of participants had undiagnosed narrow angles. There was no significant change in intraocular pressure, cup-to-disc ratio, or pattern standard deviation in study eyes compared with baseline or fellow eyes at 3 months. Vision improved in all study eyes at 3 months compared with baseline (P = 0.013), but remained significantly worse than fellow eyes (P < 0.001). Central subfield and temporal peripapillary RNFL thickness were significantly greater in eyes with epiretinal membrane (P < 0.05), and resolution after surgery correlated with visual improvement (P < 0.05). CONCLUSION: The 3-month results do not indicate any increased risk for open-angle glaucoma but suggest that a relatively high percentage of eyes may be at risk of angle closure glaucoma. Temporal RNFL thickness and central subfield were increased in eyes with epiretinal membrane, and resolution correlated with degree of visual recovery.

The Ahmed versus Baerveldt study: three-year treatment outcomes.

OBJECTIVE: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. DESIGN: International, multicenter, randomized trial. PARTICIPANTS: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. METHODS: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. RESULTS: A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37% had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51% in the Ahmed group and 34% in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49% reduction) and 14.4±5.1 mmHg in the Baerveldt group (55% reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42% reduction) and 1.1±1.3 in the Baerveldt group (65% reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P< 0.001). The 2 groups had similar complication rates (52% Ahmed, 62% Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0% Ahmed, 6% Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38% Ahmed, 50% Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. CONCLUSIONS: Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications.

The Ahmed Versus Baerveldt study: one-year treatment outcomes.

OBJECTIVE: To report the 1-year treatment outcomes of the Ahmed Versus Baerveldt (AVB) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: A total of 238 patients were enrolled in the study, including 124 in the Ahmed group and 114 in the Baerveldt group. METHODS: Patients aged 18 years or older with uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA), to be followed for 5 years. MAIN OUTCOME MEASURES: The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (5-18 mmHg with ≥ 20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions. RESULTS: There were no significant differences in baseline ocular or demographic characteristics between the study groups with the exception of sex. Preoperatively, the study group had a mean IOP of 31.4 ± 10.8 mmHg on a mean of 3.1 ± 1.0 glaucoma medications with a median Snellen acuity of 20/100. The cumulative probability of failure a 1-year was 43% in the Ahmed group and 28% in the Baerveldt group (P = 0.02). The mean IOP at 1 year was 16.5 ± 5.3 mmHg in the Ahmed group and 13.6 ± 4.8 mmHg in the Baerveldt group (P < 0.001). The mean number of glaucoma medications required was 1.6 ± 1.3 in the Ahmed group and 1.2 ± 1.3 in the Baerveldt group (P = 0.03). Visual acuity was similar in both groups at all visits in the first year (P = 0.66). In the first year after surgery, there were a similar number of patients who experienced postoperative complications in the 2 groups (45% Ahmed, 54% Baerveldt, P = 0.19), but a greater number of patients in the Baerveldt group required interventions (26% Ahmed vs. 42% Baerveldt, P = 0.009). CONCLUSIONS: The Baerveldt-350 group had a higher success rate than the Ahmed-FP7 group after 1 year of follow-up, but required a greater number of interventions. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Optical coherence tomography findings in ocular decompression retinopathy.

Three days following trabeculectomy surgery, a 47-year-old woman experienced a decline in visual acuity to 20/400. Fundus findings were consistent with decompression retinopathy, and optical coherence tomography revealed macular thickening, cystoid macular edema, and neurosensory macular detachment. The foveal anatomy normalized following topical treatment, and visual acuity returned to 20/30 by 10 weeks postoperatively. Both macular detachment and cystoid macular edema may contribute to acute decline in visual acuity in decompression retinopathy. Optical coherence tomography facilitated the prompt detection of treatable pathology, which resolved following appropriate medical therapy.

The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma II: longer-term outcomes from a single surgeon.

OBJECTIVE: To analyze the longer-term surgical outcomes of Ahmed and Baerveldt shunt implants in the treatment of refractory glaucoma. DESIGN: Retrospective, nonrandomized, comparative trial. PARTICIPANTS: Consecutive patients who underwent glaucoma shunt implantation (70 Baerveldt, 48 Ahmed) by a single surgeon. METHODS: Follow-up retrospective analysis of 118 consecutive cases of refractory glaucoma that required placement of either Ahmed or Baerveldt shunt implants for intraocular pressure (IOP) control. The longer term clinical course (survival curve analysis up to 48 months) was reviewed. MAIN OUTCOME MEASURES: The primary outcome measure was surgical success (6 mmHg < or = IOP < or = 21 mmHg without additional glaucoma surgery or devastating complication). Secondary outcome measures included mean IOP and number of medications used at the following postoperative visits: day 1, 1 week, 1 month, 3 months, 6 months, and every 6 months thereafter (up to 48 months). In unsuccessful cases, the median time to failure was determined. RESULTS: No significant differences in success rates were noted at 1, 2, 3, or 4 years after surgery, with 4-year success rates of 62% for the Ahmed group and 64% for the Baerveldt group (P = 0.843). Mean IOPs were comparable from 1 to 48 months (P>0.05). However, patients in the Ahmed group required more glaucoma medications at 18, 24, 30, and 36 months (P<0.05). The median times to failure were 3.2 months in the Baerveldt group, compared with 15.0 months in the Ahmed group (P = 0.009). CONCLUSIONS: No differences were observed in longer term survival rates and IOP profiles between Ahmed and Baerveldt shunt implants up to 48 months following surgery. Patients in the Baerveldt group were more likely to develop early postoperative hypotony-related complications and failure, whereas patients undergoing Ahmed implants were more likely to be on additional glaucoma medications (starting at 18 months postsurgery) and develop later onset failure.