Efficacy, safety, and cost-effectiveness of biosimilars of bevacizumab in näive patients with diabetic macular edema.

OBJECTIVES: Anti-vascular endothelial growth factor (VEGF) therapy restores retinal architecture and enhances vision in diabetic macular edema (DME). Bevacizumab is an off-label anti-VEGF drug that effectively treats DME. The safety and efficacy of bevacizumab biosimilars, which are more affordable than the original medication, still need to be established. This study aimed to assess the cost-effectiveness, efficacy, and safety of biosimilars for treating patients with naïve DME across various price ranges that are accessible in the Indian market. MATERIALS AND METHODS: Two biosimilars, BevaciRelTM (Reliance Life Sciences Pvt. Ltd.) and ZyBev (Cadila Healthcare Limited), were compared to their original, Avastin (Roche Products [India] Pvt. Ltd.), in a randomized, control study. Three end-notes were used to assess safety and efficacy: persistence, improvement, and adverse events. Cost-effective analysis was carried out using a decision-tree analysis model. RESULTS: This study included 69 (59%) men and 54 (41%) women with naïve DME. The cohort had an average log MAR visual acuity of 0.87 ± 0.22, and the central retinal thickness at baseline on OCT was 398.5 ± 37.61 µm. The visual acuity showed a similar improvement, and there was a decrease in central retinal thickness as observed on OCT across the groups. The incremental cost-effectiveness ratio was 10.8. CONCLUSIONS: The biosimilars of bevacizumab are safe and efficacious in treating DME in a cost-effective manner.

Survey and analysis of accessibility, availability, and affordability of topical glaucoma medicines.

PURPOSE: Affordability and availability of medicines is a growing global challenge for health-care systems. Access to medicines is recognized as an important determinant of treatment adherence. The access to glaucoma medicines and how it affects glaucoma management are not known. The purpose of this study was to determine the availability, affordability, and accessibility of topical intraocular pressure (IOP) -lowering eye drops in Haryana state of northern India using the World Health Organization (WHO)/Health Action International (HAI) methods. METHODS: A cross-sectional study was done to collect data on prices and availability of glaucoma topical medications in public and private sector pharmacies and retail outlets using the WHO/HAI methodology between October 2021 and January 2022. The availability and affordability of topical glaucoma medicines was determined. Comparison of the local price with international prices was done by calculating the median price ratio (MPR). RESULTS: A total of 191 facilities were randomly sampled across 11 ( n = 55) urban, 29 ( n = 92) semi-urban, and 44 ( n = 44) rural places during the study period. The availability of topical medication for glaucoma was low (35.7 ± 22.3) across all sampled sites and all classes of topical glaucoma medications. The median price of topical medication and availability were negatively correlated, Pearson's coefficient r (18) = -0.44, P 0.05, though the relationship was weak. A lowest paid, unskilled Indian government worker must spend between 15% and 203% of their daily wage to acquire a glaucoma medication. CONCLUSION: The availability and accessibility of topical glaucoma medications was low in this survey.

A Century of Laffer-Ascher Syndrome.

Laffer-Ascher syndrome is characterized by double lips, blepharochalasis, and nongoiter thyroid enlargement. The syndrome was first described in 1923 and several case reports have been published thereafter. We illustrate the syndrome through a case of a 46-year-old woman who presented with both upper and lower double lips and blepharochalasis, and review the literature published. Thyroid involvement is the most inconsistent feature of the syndrome complex described in reported cases.

Risk Factors, Clinical Manifestations, and Outcomes of COVID-19-Associated Mucormycosis and Other Opportunistic Fungal Infections.

INTRODUCTION: An epidemic of opportunistic fungal infections during the second wave of the coronavirus disease 2019 (COVID-19) pandemic badly affected India in 2021. Several unknown, unique factors played a role in its causation and survival outcomes, including the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The purpose of this study was to analyse the probable underlying risk factors and to know immediate and late outcomes of opportunistic fungal infections in the unique setting of the SARS-CoV-2 pandemic. METHODS: In this retrospective cohort study, clinical records of COVID-19-associated opportunistic fungal infections were reviewed for risk factors, clinical features, microbiological and pathological findings, and outcomes during a one-year follow-up at a tertiary care teaching hospital in Northern India. RESULTS: A total of 390 patients were admitted with symptoms and clinical signs consistent with the criteria for the diagnosis of COVID-19-associated mucormycosis (CAM). Diabetes mellitus was the most common comorbidity (74%). During the management of SARS-CoV-2, 192 (49%) patients received corticosteroids, 151 (39%) were on oxygen support, and 143 (37%) used at-home steam inhalation. Masks of any type were used by 236 (60.5%) patients, of whom most used cloth masks (n=147, 37.6%). Microbiologically, fungal growth was positive in 138 (35.3%) samples; of these, 74 (19%) had non-Mucorales fungal colonies. The fungal infection invaded structures beyond the paranasal sinuses in 60% of the cases. The overall mortality in this cohort after one-year follow-up was 40.25%. CONCLUSIONS: An alignment of several predisposing conditions precipitated an epidemic of opportunistic fungal infections during the COVID-19 pandemic that resulted in high mortality in affected patients.

Comparison of aqueous humor ascorbic acid level in smokers and non-smokers.

In this study, we studied effect of smoking on ascorbic acid level in aqueous humor. A cohort of 112 individuals undergoing cataract surgery for senile cataract (mean ± SD age-65 ± 8 years) was sub-grouped as smoker (n = 56) and non-smoker (n = 56) based on smoking habit. The aqueous humor sample was collected in beginning of the surgery and quantitative ascorbic acid estimation was done by colorimetric method (spectrophotometry at λ = 578 nm) using commercially available assay kits using the auto-analyzer assay procedure. The mean (±SD) aqueous humor ascorbic acid level was 1396 ± 629 µmol/L among non-smokers and 774 ± 436 µmol/L among smokers (p < 0.0001). The aqueous humor ascorbic acid concentration is significantly lower in smokers compared to non-smokers. The aqueous humor ascorbic acid concentration is affected by gender but not by age or morphology of cataract.

Erroneous assumption of ocular hypertension in patients with elevated intraocular pressure.

PURPOSE: To determine the proportion of erroneously assumed ocular hypertension (OHT) among referred patients of elevated intraocular pressure (IOP) seen in glaucoma clinic of a teaching hospital in Northern India. METHODS: Retrospective review of case records of referred, diagnosed patients of OHT or unspecified glaucoma seen between January 2019 and March 2020. Using an algorithmic clinical approach, including gonioscopy, Goldmann applanation tonometry (GAT), and pachymetry, underlying cause for elevated-IOP was amended and proportion of erroneously assumed OHT was calculated. RESULTS: Of 276 patients diagnosed either as OHT or unspecified glaucoma before being seen at our glaucoma clinic, 44 (16%) had IOP within normal range (10-21 mmHg) on GAT. In 97 (35%) cases elevated-IOP was associated with angle closure. The central corneal thickness (CCT) was >550 µm in 39 (14%) patients with elevated-IOP. The proportion of erroneously assumed OHT was 70% in this study. CONCLUSION: The elevated-IOP does not imply with OHT unless evident through comprehensive clinical examination and appropriate investigations.

Cataract surgical reach: Falling short to catch white cataracts!

Purpose: The aim of this study was to know proportion of white cataracts from among patients coming for cataract surgery, and to find causes delaying uptake of cataract surgery. Methods: A hospital-based, prospective study enrolled patients of senile cataract between April 2018 and March 2019. The proportion of white cataract was calculated and underlying causes delaying uptake of cataract surgery studied. Results: White cataracts constituted 13.5% of total 3634 senile cataract patients, with gender disparity disfavoring women. Bilateral white cataract was presentation in 39 (8%) patients and lens-related glaucoma in 24 (5%) patients. Pseudophakia in the other eye was single most common cause of delay. Conclusion: A large proportion of white cataracts suggest that penetration of cataract surgical services in not reaching to the most eligible individual.

Practice pattern of cataract surgeons when operating on seropositive patients.

Purpose: The aim of this study is to know practice pattern of cataract surgeons when operating on patients, positive for blood-borne viral infections (BBVIs), namely, hepatitis B virus, hepatitis C virus, and human immunodeficiency virus. We also studied their awareness, knowledge, and attitude toward universal precautions and guidelines. Methods: The telephonic survey enrolled practicing cataract surgeons, who were interviewed to record responses pertaining to their practice using an open-ended questionnaire. We studied statistical significance of difference of frequency of prick injuries in topical versus peribulbar anesthesia, and phacoemulsification versus manual small incision cataract surgery by employing Chi-square test. Significance of proportion was calculated using z-test. For all statistical calculations, significance level was set at 0.05%. Results: Of 623 ophthalmologists contacted, responses of 479 (79%) ophthalmologists were analyzed. Maximum participants were in private practice (48%). During whole practicing carrier, 313 (65%; 95% confidence interval [CI]: 61-70) participants admitted having suffered injury with needle or sharp instruments; of these, 204 (65%; 95% CI: 60-70) participants did not report their injury. Wearing "double gloves" during cataract surgery was the most common barrier adopted by participants. Conclusion: We found high prevalence of occupational-related sharp injuries among ophthalmologists in this survey. Majority of them were aware of universal precautions, but adherence to postexposure prophylaxis was lacking.

Real-time polymerase chain reaction for diagnosis and management of HIV-induced uveitis.

Intraocular (IO) inflammation in patients with Human immune deficiency virus (HIV) infection can be due to opportunistic infections, immune recovery uveitis, drugs used in the management or a primary manifestation of HIV itself. We studied the role of RT-PCR for HIV RNA in confirming the diagnosis of HIV induced uveitis and its useful in the management and follow-up of these patients.

Seroprevalence, risk associations, and cost analysis of screening for viral infections among patients of cataract surgery.

PURPOSE: The purpose of this study was to estimate the prevalence of blood-borne viral infections (triple H: HBV-hepatitis B virus, HCV-hepatitis C virus, and HIV-human immunodeficiency virus) among cataract patients, sought possible risk associations and discuss feasibility of universal preoperative screening. METHODS: This prospective, cross-sectional study enrolled consecutive patients of senile cataract. They were screened by immunoassay-based rapid diagnostic card tests for blood-borne viral infections. Positive cases were confirmed with confirmatory ELISA tests. Seropositive patients were enquired about the exposure to possible risk associations for acquiring these infections. Cost of card test per patient was calculated. RESULTS: The prevalence of seropositivity for triple H viral infections (HBV, HCV, and HIV) among patients of senile cataract was 5.9% (95% confidence interval [CI]: 5.3-6.6), and HCV was most common viral infection. The dental extraction was most common (54%; 95% CI:48-60) possible risk association. The total cost of primary screening per patient for triple H infections(HBV, HCV, and HIV) was $0.93. CONCLUSION: The prevalence of blood-borne viral infection among cataract patients is high in this area. Awareness of the prevalence of blood-borne viral infections in service area, along with knowledge of rate of accidental exposure and risk of transmission would help to understand cost-effectiveness of universal preoperative screening before cataract surgery.

Vision Screening of Younger School Children by School Teachers: A Pilot Study in Udaipur City, Western India.

PURPOSE: To assess the reliability of school teachers for vision screening of younger school children and to study the pattern of vision problems. METHODS: In this cross-sectional study, trained school teachers screened 5,938 school children aged 3 to 8 years for vision and ocular disorders. Children were cross screened by professionals to assess the reliability of the teachers in vision screening and detecting ocular disorders in these children. The pattern of visual acuity, ametropia and ocular disorders was studied. RESULTS: Sensitivity and specificity of the vision screening by school teachers was 69.2% (95% CI: 66.8-71.5%) and 95.3% (95% CI: 94.5-95.8%), respectively. The positive predictive value was 83.5% (95% CI: 81.4-85.6%) and negative predictive value was 89.8% (95% CI: 88.8-90.6%). The kappa statistic was 0.68 (95% CI: 0.66-0.7). CONCLUSION: School teachers could effectively screen younger school children for vision assessment and ocular disorders.

Acute onset bilateral myopia in convalescence phase of varicella infection.

A 13 year old boy presented with sudden onset of painless blurring of vision in his both eye, twenty days following varicella infection. Ocular examination revealed -3.00 DS refractive error; and cilio-choroidal effusion. After treatment at 1 months he had unaided 6/6; N-6 vision in both eyes.

Awareness, knowledge, and practice: a survey of glaucoma in north Indian rural residents.

BACKGROUND: Studies done on the prevalence of glaucoma have reported a high proportion of undiagnosed patients. Late diagnosis is related to increased risk of glaucoma associated with visual disability. Lack of awareness and non-availability of appropriate screening procedures are among the major reasons for non-diagnosis or late diagnosis of glaucoma. The present study has been undertaken to evaluate the level of awareness about glaucoma among the North Indian rural population. MATERIALS AND METHODS: A group-administered, questionnaire-based survey, involving 5000 rural residents (aged 20 and above) was conducted through random sampling. The questionnaire was structured to evaluate the level of awareness and knowledge about glaucoma and the effect of gender, education status, and glaucoma diagnosis was also studied. The source of awareness about glaucoma was also questioned. RESULTS: Of the 5000 individuals enrolled for the survey, responses from 4927 (98.5%; 95% Confidence Interval (CI): 98.2 - 98.9) participants, including 3104 males (63%; 95% CI: 61.7 - 64.3) and 1823 females (37%; 95% CI: 35.7 - 38.3) were evaluated. A total of 409 (~8.3%; 95% CI: 7.6 - 9.14) respondents were aware about glaucoma and only 93 (1.89%; 95% CI: 1.55 - 2.31) were qualified as having knowledge about glaucoma as per the set questionnaire. Education was the only variable significantly correlated (P value < 0.001) with the awareness and knowledge of glaucoma out of the parameters included in this study. Close acquaintance with a glaucoma patient was the most common source of information. CONCLUSIONS: There is a lack of awareness about glaucoma among the rural residents of North India. The study findings stress the need to spread awareness about glaucoma for prevention of glaucoma-related blindness.

Self-vision testing and intervention seeking behavior among school children: a pilot study.

PURPOSE: Refractive error is the most common cause of visual impairment among school children. Worldwide, school vision testing is one major area of thrust to address vision screening among school children, and is carried out by a diverse group of professionals and non-professionals, with variable success rates. In a pilot study we aimed to determine how efficiently and reliably students could self-examine their vision and how many actually seek intervention for refraction and eventually wear glasses. METHODS: The pilot study was done in 25 schools in a rural area of northern India. The methodology of self-assisted vision examination (SAVE) was directly demonstrated to school children. School children self-examined their visual acuity, and sensitivity, specificity and positive and negative predictive values were calculated after secondary screening by professionals. Students requiring refraction were given referral slips. Frequency of uptake of glasses for those referred for refractive services was assessed in a follow-up visit. RESULTS: A total of 7411 students in 6th to 12th standard were enrolled in the pilot study. Sensitivity and specificity of the SAVE strategy were 96.22% (95% confidence interval [CI] 94.52-97.43%) and 90.23% (95% CI 87.79-92.23%), respectively. The positive predictive value was 90.83% (95% CI 88.55-92.71%) and negative predictive value was 95.95% (95% CI 94.13-97.24%). At the time of follow-up 66% of students had undergone refraction and 81% of these were wearing glasses. CONCLUSION: SAVE provides a simple, acceptable and valid alternate strategy for school vision screening. However, factors influencing procurement of glasses and their use will require further study.