National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic: An analysis.

The world currently faces an unprecedented pandemic outbreak of coronavirus disease (Covid-19). The novel nature of the virus and very high infection rates have not only increased the urgency to find a vaccine or cure but have also led to drastic changes in the mode of conduct of research. Thus, the Indian Council of Medical Research has developed the "National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during Covid-19 Pandemic" for guidance during the review of research. Here, we attempt to analyse the strengths and limitations of these guidelines to assess if the unique ethical challenges faced during research in the current situation are adequately identified and addressed and if foundational values and principles of research ethics have been taken into account in these guidelines.

Ergonomic practices and musculoskeletal disorders among ophthalmologists in India: An online appraisal.

INTRODUCTION: Ergonomics in ophthalmology is neither taught during professional training nor does it readily receive consideration or priority in clinical practice. Owing to a high prevalence of musculoskeletal disorders among ophthalmologists, ergonomic awareness, and practices are vital in averting this modern epidemic. OBJECTIVE: To assess the ergonomic practices and prevalence of self-reported musculoskeletal disorders among ophthalmologists in India. METHOD: An online survey was conducted among ophthalmologists who were registered with the All India Ophthalmological Society of India using a pre-tested and validated questionnaire. RESULTS: The prevalence of self-reported musculoskeletal disorder in the 377 participants was 75.3% (284; 95% confidence interval: 70.6-79.5). Low back pain (149, 52.9%) was the most commonly reported symptom. Musculoskeletal disorder-attributed productivity loss was reported by 58.45% (166) of the respondents. Musculoskeletal disorder was most frequently associated with less than 10 years of work experience (odds ratio: 1.2; 95% confidence interval: 1.1-1.3, p = 0.01) and lack of good clinic (odds ratio: 1.7; 95% confidence interval: 1.1-2.7, p = 0.03) and operation room ergonomic practices (odds ratio: 1.8; 95% confidence interval: 1.1-2.9, p = 0.03). Only 27.9% (105) of the respondents had accessed information related to ergonomics in ophthalmic practice. CONCLUSION: The self-reported musculoskeletal disorder among ophthalmologists in India is quite high and significant enough to cause some degree of productivity loss. It is thus imperative to emphasize the implementation of good ergonomic practices, especially among relatively young ophthalmologists.

Does the phaco TIp position during clear corneal Phacoemulsification Surgery adversely affect corneal endothelium? TIPS study protocol for a randomised, triple-masked, parallel-group trial of bevel-up versus bevel-down phacoemulsification.

Introduction: Globally, at least 30 million cataract surgeries are required annually to prevent cataract-related blindness. Corneal endothelial decompensation is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The increasing ageing population and reduced visual impairment threshold for cataract surgery have resulted in rising cataract surgical rates and hence, an increase in corneal endothelial decompensation is expected. The role of phaco tip position on corneal endothelial damage is ambiguous. Previous studies have reported contradictory results and were also underpowered to detect a significant difference due to small sample sizes. With no consensus regarding the most cornea-friendly phaco tip position (bevel-up versus bevel-down) during phacoemulsification, we propose a randomised clinical trial with a robust design using direct chop phaco-technique. Objective: To compare the effect of phaco tip position (bevel-up vs. bevel-down) on corneal endothelial cell count during phacoemulsification. Methods: A randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio is proposed. By adopting stratified randomisation (according to cataract grade), we will randomly allocate 480 patients aged >18 years with immature cataract into bevel-up and bevel-down groups at two centres. History of significant ocular trauma, previous intraocular surgery, shallow anterior chamber, low endothelial cell count, pseudoexfoliation syndrome, intraocular inflammation, and corneal endothelial dystrophy are the key exclusion criteria. The primary outcome is postoperative endothelial cell count at one month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30, and intraoperative complications. Trial registration: Clinical Trial Registry of India CTRI/2019/02/017464 (05/02/2019).

Proteomics and Visual Health Research: Proteome of the Human Sclera Using High-Resolution Mass Spectrometry.

Eye disorders and resulting visual loss are major public health problems affecting millions of people worldwide. In this context, the sclera is an opaque, thick outer coat covering more than 80% of the eye, and essential in maintaining the shape of the eye and protecting the intraocular contents against infection and the external environment. Despite efforts undertaken to decipher the scleral proteome, the functional and structural picture of the sclera still remain elusive. Recently, proteomics has arisen as a powerful tool that enables identification of proteins playing a critical role in health and disease. Therefore, we carried out an in-depth proteomic analysis of the human scleral tissue using a high-resolution Orbitrap Fusion Tribrid mass spectrometer. We identified 4493 proteins using SequestHT and Mascot as search algorithms in Proteome Discoverer 2.1. Importantly, the proteins, including radixin, synaptopodin, paladin, netrin 1, and kelch-like family member 41, were identified for the first time in human sclera. Gene ontology analysis unveiled that the majority of proteins were localized to the cytoplasm and involved in cell communication and metabolism. In sum, this study offers the largest catalog of proteins identified in sclera with the aim of facilitating their contribution to diagnostics and therapeutics innovation in visual health and autoimmune disorders. This study also provides a valuable baseline for future investigations so as to map the dynamic changes that occur in sclera in various pathological conditions.

Human Optic Nerve: An Enhanced Proteomic Expression Profile.

Ophthalmology and visual health are new frontiers for postgenomic research and technologies such as proteomics. In this context, the optic nerve and retina extend as the outgrowth of the brain, wherein the latter receives the optical input and the former relays the information for processing. While efforts to understand the optic nerve proteome have been made earlier, there exists a lacuna in its biochemical composition and molecular functions. We report, in this study, a high-resolution mass spectrometry-based approach using an Orbitrap Fusion Tribrid mass spectrometer to elucidate the human optic nerve proteomic profile. Raw spectra were searched against NCBI Human RefSeq 75 database using SEQUEST HT and MASCOT algorithms. We identified nearly 35,000 peptides in human optic nerve samples, corresponding to 5682 proteins, of which 3222 proteins are being reported for the first time. Label-free quantification using spectral abundance pointed out to neuronal structural proteins such as myelin basic protein, glial fibrillary acidic protein, and proteolipid protein 1 as the most abundant proteins. We also identified several neurotransmitter receptors and postsynaptic density synaptosomal scaffold proteins. Pathway analysis revealed that a majority of the proteins are structural proteins and have catalytic and binding activity. This study is one of the largest proteomic profiles of the human optic nerve and offers the research community an initial baseline optic nerve proteome for further studies. This will also help understand the protein dynamics of the human optic nerve under normal conditions.

Occupational exposure to unburnt tobacco and potential risk of toxic optic neuropathy: A cross-sectional study among beedi rollers in selected rural areas of coastal Karnataka, India.

BACKGROUND: Beedi also known as poor man's cigarette is manufactured in almost all major states of India. Beedi workers are exposed to various health risks. There is an increased risk of systemic absorption of tobacco through skin and mucous membrane. The optic nerve is susceptible to damage from several toxic substances including tobacco. This group of disorders is known as toxic optic neuropathy (TON). The association of TON with occupational exposure to unburnt tobacco in beedi rollers has not been explored. OBJECTIVES: Among the beedi rollers in Mangaluru and Bantwal talukas of Dakshina Kannada District, Karnataka, India: to assess the magnitude of potential TON utilizing colour vision and contrast sensitivity as screening tools and to identify the demographic, biological and occupational factors associated with potential TON. METHODS: A community-based cross-sectional study was conducted from April-Sept 2016 in Mangaluru and Bantwal talukas, of Dakshina Kannada district, Karnataka. Beedi rollers from twelve villages (six from each taluka) were included. In each of the selected villages, the investigators identified beedi collection centres and all the eligible beedi rollers were included in the study till the required number of beedi rollers for that village was achieved. Participants were screened at the study site for visual acuity, colour vision and contrast sensitivity and those with abnormal colour and contrast sensitivity in the presence of good visual acuity were considered to have potential TON. RESULTS: A total of 377 beedi rollers were approached; of which 365 consented to take part in the study (response rate: 96.81%). Women constituted the majority of the participants (n = 338, 92.6%). Based on the screening criteria, the prevalence of potential TON was 17.5% (n = 64, 95% CI: 13.5-21.9). On multiple logistic regression analysis, duration of beedi rolling (Adj OR: 1.061; 95% CI 1.015-1.109, p = 0.009), advancing age (Adj OR: 1.096; 95% CI 1.058-1.136, p<0.001) and presence of diabetes (Adj OR: 6.315; 95% CI 1.4572-27.376, p = 0.014) were independent correlates of potential TON. CONCLUSION: In the present study, almost one out of six beedi rollers displayed clinical signs of potential TON. Increased duration of beedi rolling, advancing age and presence of diabetes were the independent correlates of potential TON. However, with this cross-sectional study it is not possible to conclude if these factors play a role individually or collectively or are a serendipitous association, for which large scale analytical studies are required.

Central corneal thickness changes in bevel-up versus bevel-down phacoemulsification cataract surgery: study protocol for a randomised, triple-blind, parallel group trial.

INTRODUCTION: Corneal endothelial damage following phacoemulsification is still one of the major concerns of modern day cataract surgery. Although many techniques have been proposed, the risks of posterior capsular rupture and corneal endothelium damage persist. In theory, damage to the corneal endothelium is minimised by delivering the lowest phaco energy only in the direction necessary to emulsify the lens nucleus. Hence, it is believed that the bevel of the needle should be turned towards the nucleus or the nuclear fragment (ie, bevel-down. However, there is a difference of opinion among ophthalmologists with reference to the phaco tip's position (bevel-up vs bevel-down) during phacoemulsification. This subject has not been extensively studied earlier. METHODS AND ANALYSIS: This is a prospective, triple-blinded (trial participant, outcome assessor and the data analyst), randomised controlled trial with 2 parallel groups and with an allocation ratio of 1:1. It will be conducted in a tertiary care hospital, Mangaluru, India. The objective is to compare the postoperative central corneal thickness changes between the bevel-up and bevel-down techniques of phacoemulsification. Patients aged >18 years with immature cataract undergoing phacoemulsification will be selected for the study. The important exclusion criteria are the history of previous significant ocular trauma or intraocular surgery, corneal pathology, pseudoexfoliation syndrome, intraocular inflammation, a preoperative fully dilated pupil <6 mm, anterior chamber depth <2.5 mm and nuclear sclerosis grade >4. After randomisation, patients will undergo phacoemulsification surgery either by a bevel-up or bevel-down procedure. With an estimated power of 80%, the calculated sample size is 55 patients in each group. The recruitment will start from April 2016. ETHICS AND DISSEMINATION: Yenepoya University Ethics Committee, India has approved the study protocol (YUEC/148/2016 on 18 February 2016). It complies with the Declaration of Helsinki, local laws and the International Council for Harmonization-good clinical practices. TRIAL REGISTRATION NUMBER: CTRI/2016/02/006691; Pre-results.

High predictive ability of glycated hemoglobin on comparison with oxidative stress markers in assessment of chronic vascular complications in type 2 diabetes mellitus.

OBJECTIVE: To validate the diagnostic utility of oxidative stress markers along with glycated hemoglobin (HbA1c ) in the assessment of chronic vascular complications in type 2 diabetes mellitus (DM). METHODS: Ischemia modified albumin (IMA), advanced oxidation protein products (AOPP) and malondialdehyde (MDA) were measured in 100 type 2 DM (without complications n = 50, with complications n = 50) and healthy controls (n = 50). Diagnostic potential was evaluated by receiver operating characteristic analysis and their relationships to risk variables were analyzed. RESULTS: MDA, IMA and AOPP were significantly increased in diabetics, both with and without complications. Oxidative stress parameters correlated with fasting blood glucose and HbA1c (independent predictors). Duration of diabetes was an independent predictor for AOPP and MDA. The association of IMA with diabetes duration was lost on multiple regression analysis. Area under the curve, sensitivity and specificity for MDA were 0.795, 84%, 66%; for AOPP, they were 0.762, 82%, 56%; for IMA, they were 0.611, 60%, 52%; and for HbA1c, they were 0.848, 90%, 70%, respectively. CONCLUSION: MDA and AOPP could be considered better than IMA in the evaluation of diabetes progression, but MDA is more useful as a diagnostic indicator to detect vascular complications. HbA1c measurement is of greater value than the oxidative stress markers in the prediction of vascular complications.

A Clinical Study of Meibomian Gland Dysfunction in Patients with Diabetes.

AIMS OF THE STUDY: To study the frequency of meibomian gland dysfunction (MGD) in patients of diabetes mellitus with dry eye. MATERIALS AND METHODS: A case-control cross sectional study. SAMPLING: Purposive random sampling. Totally, 200 eyes of 100 patients of diabetes mellitus and an equal number of eyes of normal subjects as control, who were gender and age matched and all of whom were symptomatic for dry eye were assessed for MGD by noting the symptoms and determining the meibomian gland expression scale for volume and viscosity, and ocular surface staining with Lissamine green, and Fluorescein sodium. All the subjects were graded for the severity of MGD. The results were compared in both the groups to ascertain whether the frequency of MGD in diabetics is significantly more as compared to nondiabetics. STATISTICAL ANALYSIS: The data were analyzed by Chi-square test for significance. P < 0.05 was considered as statistically significant. RESULTS: There was a significant increase in the frequency of MGD in diabetics as compared to the nondiabetics. CONCLUSION: Diabetes mellitus is associated with MGD.

An unusual ocular presentation of acquired immune deficiency syndrome.

A 50-year-old male who presented with bilateral keratomalacia and on subsequent evaluation was found to be human immunodeficiency virus (HIV) positive is being reported. A MEDLINE search of the literature did not reveal any report of keratomalacia as the initial presenting feature of HIV/ acquired immune deficiency syndrome.