The need for more pragmatic trials in glaucoma research.

AIM: There have been a number of clinical trials in glaucoma research published in the past two decades. Most of these trials were designed to evaluate very specific issues in selected populations placing them in the explanatory end of the pragmatic-explanatory continuum. The purpose of this study was to assess the level of pragmatism of published randomized controlled trials in glaucoma. METHODS: A PubMed search using 'glaucoma' from 1995 to 2022 and randomized controlled trial (RCT) article type was done. Each study was assessed by three independent examiners using the Pragmatic-Explanatory Continuum Indicator Summary version 2 (PRECIS-2) toolkit. Scores were calculated for each study to determine the level of pragmatism. A summed score ≥36 was indicative of a very pragmatic study. RESULTS: Thirty-two different articles were included in the analysis. These papers represented 13 different landmark trials. The median PRECIS-2 score was 32 (range, 25 for the Early Manifest Glaucoma Trial (EMGT) to 34 to the Collaborative Normal Tension Glaucoma Study (CNTGS) and the Ocular Hypertension Treatment Study). The Treatment of Advanced Glaucoma Study (TAGS), was considered very pragmatic and scored 33 points. CONCLUSION: Despite the number of RCTs in glaucoma, there is still a need for more pragmatic studies.

Complicated trabeculectomy converted into ab externo cyclodialysis.

The creation of a scleral flap during trabeculectomy can be complicated by a buttonhole, partial amputation at the limbus, and extensive thinning. In some cases, the procedure must be aborted to prevent more serious postoperative complications. This report describes a technique of converting complicated trabeculectomy into ab externo cyclodialysis. A 41-year-old patient with congenital glaucoma presented with a perforated scleral wall with the choroidal tissue exposed during the dissection of the partial-thickness scleral flap. By using a Barraquer cyclodialysis spatula through the scleral perforation, the choroid was separated from the sclera up to the scleral spur over 30° into the anterior chamber. The sclera and conjunctiva/Tenon were sutured with 10-0 nylon single sutures. Two months later, the intraocular pressure was reduced to 16 mmHg with no hypotensive topical medications. This case illustrates an alternative approach to managing a flap-related perioperative complication in trabeculectomy, which yielded good early results.

How glaucoma patients balance between the advantages and disadvantages of acceptance to the recommended treatment regimen in real-life: Perspectives from a middle-income country.

PURPOSE: Patients with primary open-angle glaucoma (POAG) are required to take long-term treatments with topical medications to halt disease progression. This cross-sectional survey aimed to describe the level of acceptance of Brazilian patients toward the long-term treatment with eyedrops and to find possible correlates of high acceptance. METHODS: POAG patients were recruited from the Glaucoma Service-Santa Casa of Sao Paulo, Sao Paulo, Brazil. Clinical and demographic data were retrieved from participants' electronic records. All patients answered the ACCEPT© questionnaire. This is a generic patient-reported outcome questionnaire specifically developed to assess patients' acceptance of long-term medications and not adherence. Summed scores and those for each domain were calculated to range from 0 to 100 with a higher score indicating greater acceptance. RESULTS: The sample comprised 96 patients with POAG. The mean age was 63.2 ± 8.9 years; 48 were male and 48 female; 55 (57.3%) were white, 36 (37.5%) African-Brazilian, and 5 (5.2%) were of mixed color; most patients (97.9%) had less than high school degree and all had a family income

Complicated trabeculectomy converted into ab externo cyclodialysis

ABSTRACT The creation of a scleral flap during trabeculectomy can be complicated by a buttonhole, partial amputation at the limbus, and extensive thinning. In some cases, the procedure must be aborted to prevent more serious postoperative complications. This report describes a technique of converting complicated trabeculectomy into ab externo cyclodialysis. A 41-year-old patient with congenital glaucoma presented with a perforated scleral wall with the choroidal tissue exposed during the dissection of the partial-thickness scleral flap. By using a Barraquer cyclodialysis spatula through the scleral perforation, the choroid was separated from the sclera up to the scleral spur over 30° into the anterior chamber. The sclera and conjunctiva/Tenon were sutured with 10-0 nylon single sutures. Two months later, the intraocular pressure was reduced to 16 mmHg with no hypotensive topical medications. This case illustrates an alternative approach to managing a flap-related perioperative complication in trabeculectomy, which yielded good early results.

Perspectives on Adherence to Glaucoma Medical Therapy in Brazilian Patients.

BACKGROUND: Poor adherence to glaucoma medication regimens may be associated with subsequent optic nerve damage and irreversible visual loss. Specific barriers to effective patient adherence in low-middle income countries are not fully recognized and new disease-specific instruments to assess adherence have been developed. OBJECTIVE: The purpose of this cross-sectional study was to evaluate adherence of primary open-angle glaucoma (POAG) patients to treatment in a middle-income country. METHODS: POAG patients were recruited from the Glaucoma Service - Irmandade da Santa Casa de Misericordia de Sao Paulo, Sao Paulo, Brazil. Clinical and demographic data were retrieved from participants' electronic records. All patients answered the Glaucoma Treatment Compliance Assessment Tool (GTCAT). This 27-item questionnaire was designed to evaluate multiple behavioral factors associated with glaucoma medication adherence. RESULTS: The sample comprised 96 patients with POAG. The mean age was 63.2 ± 8.9 years; 48 were male and 48 female; 55 (57.3%) were White, 36 (37.5%) African-Brazilian, and five (5.2 %) were of mixed color. Most patients (97.9%) had less than a high school degree and all had a family income < US$10,000. The GTCAT identified 69 (71.8%) patients who "sometimes forget to use drops," 68 (70.8%) patients who "sometimes fall asleep before dosing time," and 60 (62.5%) patients "whose drops aren't with them at the time to take them"; 82 (85.4%) patients admitted to using "reminders to take medications." Eighty-two (85.4%) patients agreed that "doctor answers my questions," and 77 (80.5%) said "they are happy with their eye doctor." CONCLUSIONS: The GTCAT identified a number of mostly unintentional factors associated with adherence in this cohort of Brazilian patients. The data may impact on how to understand and improve adherence to ocular hypotensive treatment in the Brazilian population.

Estimated intracranial pressure in glaucoma patients and its correlation with disease severity.

PURPOSE: To compare the intracranial pressure (ICP) and the translaminar pressure difference (TLPD) between primary open-angle glaucoma (POAG) patients and non-glaucoma subjects and to assess the correlation between the ICP (and TLPD) and glaucoma severity. METHODS: This was a cross-sectional study. Patients with POAG and age-matched controls were included. ICP was calculated using proxy algorithm to attain indirect surrogate parameter values. Differences were compared between groups. The correlation between ICP (and TLPD) and both structural and functional variables was evaluated using linear and non-linear regression analysis and estimated with Pearson's correlation coefficient. RESULTS: Fifty patients with POAG and 25 normal controls were included. The mean estimated ICP was lower in POAG (10.9 ± 3.2 mmHg) as compared to controls (15.0 ± 3.7 mmHg, p < 0.001). The TLPD was higher in POAG (2.6 ± 4.1 mmHg) when compared to non-glaucoma (-0.3 ± 3.6 mmHg, p = 0.002). ICP displayed a negative correlation with cup-to-disk ratio (r = -0.566; 95% CI, -0.699 to -0.369, p'0.000) and a positive correlation with retinal nerve fiber layer thickness (r = 0.441; 95% CI, 0.230 to 0.612; p'0.000). There was a positive correlation between ICP and mean deviation (r = 0.280; 95% CI, 0.05 to 0.482, p = 0.017). CONCLUSION: Glaucoma patients presented lower ICP values; lower ICP values were associated with more advanced disease. These observations strengthen the role of ICP as a potential player on the glaucoma pathogeny.

Face memory deficit in visually impaired children who live in a developing country.

PURPOSE: The development of face processing abilities is a continuous process reaching maturity in adulthood. To achieve it in plenitude, children must have an adequate visual function. The purpose of this study was to assess how the face memory ability of children with visual impairment living in a developing country compares to those with normal vision in the same setting. METHODS: This was a case-control study. Children with visual impairment of different causes and age-matched normal controls underwent a complete eye examination and the Cambridge Face Memory Test for Children (CFMT-C). Images were presented on a computer screen and the test results were expressed as a percentage of right answers (%). Children with impaired vision were assorted into binocular and monocular deficiency and the groups were compared with the Kruskal-Wallis test. RESULTS: The sample comprised 40 children with visual impairment and 31 age-matched controls. The groups did not differ in age and gender distribution. Patients with binocular impairment (18 subjects) had lower mean CFMT-C scores, as compared to monocular patients (22 patients with strabismic amblyopia) and children with normal vision (57.7 ± 18.9, 76.2 ± 15.6, and 71.3 ± 12.7, respectively, p = 0.008). CONCLUSIONS: Children with binocular visual impairment had diminished face memory ability. Amblyopia due to strabismus did not affect face memory. Attempts should focus on the prevention of visual loss and early rehabilitation so that these children can develop adequate face memory ability.

Assessment of everyday functioning in visually impaired children from a developing country1.

PURPOSE: To assess the functional capabilities and performance in children with visual impairment who live in a developing country. METHODS: This was a case-control study, including binocular and monocular visually impaired children and non-visually disabled controls aged between 4 and 12 years. All participants underwent a basic ophthalmic exam and caregivers answered the Pediatric Evaluation of Disability Inventory (PEDI). The results were compared among the groups with ANOVA. RESULTS: The sample included 35 children with visual disability (21 binocular and 14 monocular) and 23 age-matched controls. The groups did not differ in age, gender, and ethnicity. For the functional skills scale, binocular impaired children had lower scores than children from the monocular group and controls in all three domains - self-care (59.6±33.0, P < 0.001), mobility (38.5±26.6, P < 0.001), and social function (61.0±28.2, P < 0.001). For the caregiver assistance scale, children from the binocular group presented lower scores in the self-care (64.7±29.6, P = 0.002), mobility (50.6±36.3, P < 0.001), and social function (65.9±33.4, P = 0.008) domains as compared to monocular and controls. Children with monocular visual disability presented very similar scores to controls (all P > 0.05). CONCLUSION: Children with binocular visual impairment presented some degree of difficulty with everyday functioning whereas monocular visual impairment did not cause any limitation in function.

Predictive values of the Pediatric Penetrating Ocular Trauma Score and the Toddler/Infant Ocular Trauma Score in Brazilian children with open globe injury.

OBJECTIVE: This study compared the prognostic value of the Pediatric Penetrating Ocular Trauma Score (POTS) with the Toddler/Infant Ocular Trauma Score (TOTS) in a cohort of Brazilian children with open-globe injuries. METHODS: This retrospective, observational case series included consecutive children with open-globe injuries seen at the Santa Casa de Sao Paulo Eye Emergency Service. The medical records of all patients were reviewed for data analysis, including the circumstance and time of injury, type of penetrating injury, initial and final visual acuity (VA), time of surgery, and associated eye diseases. The test characteristics of POTS and TOTS for VA were calculated and compared by the McNemar test. RESULTS: Thirty patients were included. The mean age was 3.9 ± 1.6 years; 20 were male patients and 10 were female patients. Most wounds were limited to the anterior segment (93.3%). The sensitivity for the POTS was higher than that of the TOTS (100%; 95% confidence interval [CI], 75.3-100 vs. 61.5%; 95% CI, 31.6-86.1; P = 0.014). The specificity was not significantly different (14.3%; 95% CI, 0.4-57.8 vs. 0%; 95% CI, 0-41.0; P = 0.563). The accuracy for the POTS was higher than the TOTS (70.0%; 95% CI, 45.7-88.1 vs. 40.0%; 95% CI, 19.1-63.9; P = 0.001). CONCLUSION: In this cohort of Brazilian children with open-globe injuries, the POTS had better accuracy than did the TOTS in predicting VA after treatment.

Predictors of parental satisfaction with the pediatric ophthalmology care in a Brazilian hospital.

The purpose of this cross-sectional study was to assess the satisfaction of parents of visually impaired children with the pediatric ophthalmology care in a Brazilian hospital and to associate parental satisfaction with predictor variables. The study enrolled children with a binocular and monocular visual impairment aged between 4 and 17 years from a single site in Brazil between June 2019 and May 2020. Parents or legal guardians answered the Brazilian version of the Pediatric Quality of Life InventoryTM (PedsQLTM 3.0) Healthcare Satisfaction Generic - Parents. Linear regression analysis was used to investigate the association between the PedsQL scores and predictor variables. The sample included 82 children and their respective parents. The mean PedsQL score was 90.3 ± 6.6 (out of 100). In the univariate model, child female sex (p = 0.056), child older age (p = 0.078), better eye visual acuity (VA; p = 0.016), and worse eye VA (p = 0.008) were significantly associated with higher scores. The multivariate estimates identified the worse eye VA (p = 0.034) as a predictor of parental satisfaction. In summary, parents' satisfaction with this pediatric ophthalmology care was high. Nevertheless, a continuous evaluation is warranted to keep up with parents' expectations and plan for possible improvements in clinical practice.

Translaminar Pressure Difference and Ocular Perfusion Pressure in Glaucomatous Eyes with Different Optic Disc Sizes.

PURPOSE: Intracranial pressure (ICP) and ocular perfusion pressure (OPP) are both involved with the pathogenesis of glaucoma. The orbital ICP determines a retrolaminar counter pressure that is antagonistic to the intraocular pressure (IOP). The purpose of this study is to evaluate whether the translaminar pressure difference (TLPD) and the OPP varies in glaucoma patients with different optic disc sizes. METHODS: In this university hospital-based, observational, cross-sectional clinical study, all patients underwent an ophthalmic evaluation. Blood pressure, height, weight, and the results of retinal nerve fiber layer examination with optical coherence tomography examination were recorded. TLPD and OPP were calculated for each patient using proxy algorithms to attain indirect surrogate parameter values. Patients' eyes were stratified into three quantiles according to optic disc sizes and the differences compared. Data from both eyes were used after using the appropriate correction for inter-eye dependency. RESULTS: The sample consisted of 140 eyes of 73 patients with primary open-angle glaucoma and suspects. Patients with large disc size presented with higher TLPD as compared to those with average and small-sized discs (2.4 ± 4.5, 2.8 ± 3.8, and 3.7 ± 4.7 mmHg for first, second, and third tertile, respectively (P < 0.000). OPP did not vary according to the optic disc size. CONCLUSION: Glaucoma patients with larger optic discs have higher TLPD. The pathological significance of this finding warrants further investigation.

25-Gauge Catheter as a Surrogate to Anterior Chamber Maintainer in Trabeculectomy.

A flat anterior chamber (AC) is a distinctive feature in status post vitrectomy eyes during trabeculectomy. The use of AC maintainers is useful to help prevent this peroperative situation. We herein describe the surgical technique using a 25-gauge intravenous catheter as a surrogate to conventional AC maintainers. A potential advantage of this approach is the low cost in the current economic environment with limited health restraints.

Correlation between ocular perfusion pressure and translaminar pressure difference in glaucoma: Evidence for a three-pressure disease?

AIM: To evaluate the correlation between the translaminar pressure difference (TLPD) and the ocular perfusion pressure (OPP) in glaucoma patients. METHODS: This was a cross-sectional study. Primary open-angle glaucoma (POAG) patients and normal individuals underwent an ophthalmic evaluation as well as blood pressure, height, and weight measurements. Intracranial pressure (ICP) and OPP were calculated using proxy mathematical formulas to attain indirect surrogate parameter values. The TLPD was calculated as intraocular pressure minus ICP. The association between the variables was evaluated using linear and non-linear regression analysis and the correlation estimated with Pearson's correlation coefficient. RESULTS: The sample included 50 POAG patients and 25 normal subjects. The mean OPP for all 75 subjects (75 eyes) was 53.1 ± 9.3 mmHg and the calculated TLPG was 3.1 ± 4.2 mmHg. TLPG showed a negative correlation with OPP (r = -0.580; 95% CI, -0.690 to -0.366; p < 0.0001). CONCLUSION: The negative correlation between OPP and TLPD observed in the study substantiates the concept of glaucoma as a three-pressure disease.

Face memory deficits in subjects with eye diseases: a comparative analysis between glaucoma and age-related macular degeneration patients from a developing country.

PURPOSE: Older people present significant declines in face recognition with age. Spatial vision (high-contrast acuity) and age are the best predictors of face recognition. Visual disabilities are more common in the older population due to aging eye diseases. The purpose of the study was to compare the face recognition memory deficit between primary open angle glaucoma (POAG) and age-related macular degeneration (ARMD) patients living in a developing country. METHODS: This was a cross-sectional, observational study. The sample comprised 64 patients with POAG, 48 with ARMD, and 52 controls. All groups were matched for age, gender, comorbidity, and ethnic distribution. Evidence of cognitive impairment was ruled out and subjects with even mild cognitive impairment were not included in the study. After a complete eye examination including measurement of the best-corrected visual acuity, fundus evaluation, and automated visual field, all subjects underwent the Cambridge face memory test (CFMT). CFMT score in percentage (%) was the main outcome measure and data were compared with ANOVA. RESULTS: The mean age was 66.6 ± 9.2, 69.8 ± 9.3, and 63.4 ± 7.3 years, for POAG, ARMD, and controls, respectively (P = 0.152). Gender, ethnicity, and comorbidity were evenly distributed among the groups. The CFMT score was 53.3 ± 15.2%, 49.8 ± 14.2%, and 62.1 ± 15.9% for POAG, ARMD, and controls, respectively (P < 0.001). CONCLUSION: ARMD and POAG patients have higher face recognition memory deficit as compared to normal controls. This might be due to a visual disability.

Expediency of the Automated Perimetry Using the Goldmann V Stimulus Size in Visually Impaired Patients with Glaucoma.

INTRODUCTION: White-on-white standard automated perimetry (AP) uses a white round stimulus with 0.43° diameter and 4.0 mm2 area (Goldmann size III). Patients with low vision have difficulty seeing such a small stimulus and are often tested with perimetry using the size V stimulus with 1.72° diameter and 64 mm2 area. We undertook an observational case-control study to compare the performance of patients on AP using two differently sized stimuli. METHODS: Patients with glaucoma and visual acuity worse than 20/100 underwent AP using the standard size III stimulus Swedish Interactive Threshold Algorithm (SITA) standard test and size V stimulus full threshold test. All patients were familiar with the procedure, having done the test at least twice previously. Another group of glaucoma patients with visual acuity better than 20/40 served as controls. The main outcome measures included test time, mean retinal sensitivity (MRS), foveal sensitivity (FS), fixation loss (FL), false positive (FP), false negative (FN), and the patient's subjective preference. RESULTS: Fifty patients were included in the study. Most preferred the size V stimulus target size test. For glaucoma patients, test time was shorter with size III; MRS and FS were higher with size V; FL, FP, and FN did not differ between the tests. CONCLUSION: AP with stimulus size V may be a good alternative to standard size III in selected visually debilitated patients who report difficulty undergoing a standard SITA 24-2 test.

A Comparative Analysis of the Fear of Falling Between Glaucoma and Age-Related Macular Degeneration Patients From a Developing Country.

PURPOSE: Falls are very prevalent in the older population. Visually impaired elderly patients are prone to falls as the result of visual loss and ageing. The purpose of the study was to compare the fear of falling (FoF) between primary open angle glaucoma (POAG) and age-related macular degeneration (ARMD) patients who live in a developing country. METHODS: This was a cross-sectional observational study. After a complete eye examination including measurement of best-corrected visual acuity, ophthalmoscopy, and automated visual field, all subjects completed the Fall Efficacy Scale International Brazil (FES-I-Brazil) questionnaire. RESULTS: The sample comprised 64 patients with POAG, 48 with ARMD, and 52 controls. All groups were matched for age, sex, comorbidity, and ethnic distribution. The FES-I score was 24.6 ± 8.7, 25.3 ± 6.3, and 24.2 ± 7.7 for glaucoma, ARMD, and controls, respectively (P = 0.894). A post hoc analysis comparing all subjects with advanced visual field defect (mean deviation [MD] < -12 dB) revealed a higher FES-I score in ARMD patients as compared to POAG ones (46.2 ± 16.8 and 24.0 ± 7.7 for ARMD and POAG, respectively, P < 0.001). CONCLUSION: In this cohort of elderly subjects with eye diseases, the FoF was similar among groups; however, ARMD patients with more compromised visual field had higher FoF as compared to POAG patients and controls. TRANSLATIONAL RELEVANCE: A high rate of fear of falling exists in ARMD patients with compromised visual field. This finding may be useful in developing multidimensional strategies to decrease fear of falling and improve quality of life in older persons living in a developing country.

Comparative Evaluation of the Prognostic Value Between the Ocular Trauma Score and the Pediatric Penetrating Ocular Trauma Score.

Controversy exists about the utility of the Ocular Trauma Score (OTS) in children. A new score was developed specifically for children-the Pediatric Penetrating Ocular Trauma Score (POTS)-which proved to be of prognostic value in young patients with penetrating eye injuries. The purpose of the study was to compare the prognostic value of OTS and POTS in children with open-globe injuries in a cohort of Brazilian children. This was a retrospective, interventional case series and included 37 children with open-globe injuries seen at the Santa Casa de Sao Paulo Emergency Service. Mean age was 8.0 ±â€Š3.9 years; 28 were male and 9 female. All patients were reviewed on the basis of time and circumstance of injury, time of surgery, type of penetrating injury, initial and final visual acuity (VA), and concomitant eye disease. Both OTS and POTS categories were calculated based on specific variables. The final achieved VA was compared with the predicted VA for both scores with Kendall's test for significant association; the agreement between the predicted VA for both OTS and POTS was accessed with the Cohen kappa coefficient. The association between OTS and achieved VA was good (Kendall Tau-b = 0.511, P = 0.001), as well as between POTS and achieved VA (Kendall Tau-b = 0.422, P = 0.002). The agreement between the predicted VA for OTS and POTS was fair (kappa = 0.400). In conclusion, in this small cohort of Brazilian children with open-globe injuries, there was no superiority of one score over the other and both OTS and POTS underestimated the potential best-corrected VA after treatment.

Qualitative assessment of online information about age-related macular degeneration available in Portuguese.

OBJECTIVE: To evaluate the quality of online information on age-related macular degeneration available in Portuguese. METHODS: The search term "age-related macular degeneration" was used to browse the web using four different search engines. The first 40 websites appearing on match lists provided by each search engine were recorded and those listed in at least three tab pages selected. The Sandvik Severity Index was used as to assess website quality. RESULTS: Quality of information available on selected websites was rated average (mean Sandvik Score 7.08±2.23). CONCLUSION: Most websites disseminating information about age-related macular degeneration were of average quality. The need to readjust web-based information to target lay public and promote increased understanding was emphasized.