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Mrityunjay Singh, Harinder Singh Sethi, Sukriti Gupta, Ram Kishan Duvesh, Mayuresh Naik Department of Ophthalmology, VMMC and Safdarjung Hospital, New Delhi, IndiaCorrespondence: Ram Kishan DuveshDepartment of Ophthalmology, VMMC and Safdarjung Hospital, New Delhi, India, Tel +91 9654530391Email mayureshpnaik@gmail.comBackground: To study the prevalence of coronavirus infection among asymptomatic patients requiring eye surgery and the role of screening in prevention of spread of infection among the healthcare workers.Design: The prospective observational study was conducted in the Ophthalmology department of a tertiary care center in Delhi from September 2020 to December 2020.Setting: Patients requiring elective ophthalmological procedures in a tertiary care hospital were screened for coronavirus using the RT-PCR method. Testing methods and results were documented.Results: Among the 218 asymptomatic patients posted for elective surgery in that period, 16 (7.3%) were found to be positive for COVID-19. Those who tested positive were advised home isolation and surgery was postponed for the next 14 days. No complications were reported in these patients. One health-care worker also tested positive for COVID-19 during our study period.Conclusion: In our study, 1 out of 14 asymptomatic patients were found to be carriers for the novel virus. Asymptomatic COVID-infected patients may lead to transmission of the virus inside the hospital among the visiting patients and hospital staff while they have no adverse effect on the surgery and its outcome.Keywords: COVID-19, elective procedure, phacoemulsification

Sukriti Gupta,1 Priyanka Singh,2 Mrityunjay Singh,1 Mayuresh Naik,3 Kartikeya Srivastava1 1Department of Ophthalmology, V.M.M.C & Safdarjung Hospital, New Delhi, 110029, India; 2Department of Ophthalmology, ESI Medical College and Hospital, Faridabad, Haryana, 121012, India; 3Department of Ophthalmology, H.I.M.S.R & H.A.H. Centenary Hospital, New Delhi, 110062, IndiaCorrespondence: Mayuresh NaikDepartment of Ophthalmology, H.I.M.S.R & H.A.H. Centenary Hospital, Room no. 3 of Eye OPD, 1st Floor of OPD Building, Near GK-2, Alaknanda, New Delhi, 110062, IndiaTel +91-8287344576Email mayureshpnaik@gmail.comPurpose: To compare the efficacy of eye-drop interferon (IFN) α-2b 1 millionIU/mL with eye-ointment tacrolimus 0.03% in refractory vernal keratoconjunctivitis (VKC).Materials and Methods: Fifty patients with VKC refractory to conventional treatment with topical corticosteroids and antihistamines after 4 weeks of regular use were selected retrospectively. Patients were divided into two groups depending on whether they received eye-ointment tacrolimus 0.03% three times a day or eye-drop IFN alpha-2b 1 millionIU/mL three times a day and were followed up for 24 months. The main outcome measures were total subjective symptom score (TSSS) and total objective ocular score (TOSS).Results: Mean baseline TSSS was 7.24± 1.98 in Group A (tacrolimus group) and 7.84± 1.82 in Group B (IFN group), and it reduced to 1.12± 0.83 in Group A and 0.62± 0.41 in Group B at 6 months, which was statistically significant compared to the baseline score (p< 0.05) as well as between the two groups. Mean baseline TOSS was 6.72± 2.07 in Group A and 6.56± 2.04 in Group B, and it improved to 1 month onwards to 1.52± 0.87 in Group A and 1.0± 0.71 in Group B at 6 months, which was statistically significant compared to the baseline score (p< 0.05) as well as between the two groups. Side effects like stinging and burning sensations were seen in the tacrolimus group only.Conclusion: Our study suggests that while both eye-drop IFN α-2b 1 millionIU/mL and eye-ointment tacrolimus eye ointment 0.03% are both safe and effective steroid-sparing agents in steroid-resistant VKC. IFN α-2b results in greater improvement in subjective symptoms and objective signs, has fewer side effects in long term and is better tolerated as compared to tacrolimus.Keywords: refractory vernal keratoconjunctivitis, tacrolimus, interferon α-2b, VKC

Prasad Apsangikar, Pravin Ghadge, Manoj Naik, Santosh Nair, Ravikiran Payghan Reliance Life Sciences Pvt. Ltd, Mumbai, IndiaCorrespondence: Prasad ApsangikarReliance Life Sciences Pvt. Ltd., 282 MIDC, Thane Belapur Road, Rabale, Navi Mumbai, 400701 Tel +919867610090Fax +912235338099Email prasad.apsangikar@relbio.comPurpose: The study was undertaken for regulatory purposes to establish clinical biosimilarity and interchangeability of a ranibizumab biosimilar with reference product.Patients and Methods: A total of 159 subjects with neovascular (wet) age-related macular degeneration (AMD) were dosed with ranibizumab. Initial double blind period of 16 weeks was followed by open-label phase till week 24. Efficacy assessment was performed at weeks 1, 4, 8, 12, 16, 20 and 24 based on best corrected visual acuity. Change in central macular thickness was assessed by optical coherence tomography from baseline to week 24. Immunogenicity assessment was done in both arms at baseline, week 16 and week 24. Safety evaluation included clinical and ophthalmic examination, adverse events, vital signs, laboratory parameters and immunogenicity in both treatment arms.Results: In the biosimilar test arm, 104 (98.11%) and 105 (99.06%) patients lost fewer than 15 letters in visual acuity at week 16 and week 24, respectively, compared with 53 (100%) at both follow-ups in reference arm. In the test arm, 27 (25.47%) and 34 (32.08%) patients gained at least 15 letters in visual acuity till week 16 and week 24 respectively, compared with 17 (32.08%) and 23 (43.30%) in the reference arm. In the test arm, mean change in central macular thickness at 24 weeks was − 89.93 μm against − 64.42 μm in the reference arm. Difference was statistically not significant for any endpoint at 16 and 24 weeks for the primary and secondary endpoints.Conclusion: The evaluation of efficacy, safety and immunogenicity was concluded to show no meaningful clinical difference for biosimilar ranibizumab with the reference product.Keywords: ranibizumab, biosimilar, AMD, intravitreal, visual acuity

Sangeeta Abrol,1 Sukriti Gupta,1 Mayuresh Naik,2 Siddharth Agarwal3 1Department of Ophthalmology, V.M.M.C & Safdarjung Hospital, New Delhi 110029, India; 2Department of Ophthalmology, H.I.M.S.R & H.A.H. Centenary Hospital, New Delhi 110062, India; 3Department of Research, Mayo Clinic, Rochester, MN, USACorrespondence: Mayuresh NaikDepartment of Ophthalmology, H.I.M.S.R & H.A.H. Centenary Hospital, Room No. 3 of Eye OPD, 1st Floor of OPD Building, Near GK-2, Alaknanda, New Delhi 110062, IndiaTel +91-8287344576Email mayureshpnaik@gmail.comPurpose: To determine whether macular volume and macular GCA measurements in patients are comparable to their RNFL thickness parameters.Materials and Methods: The cross-sectional, observational study was conducted on 1380 eyes with 460 each, into three groups. Group I: patients with healthy eyes. Group II: patients diagnosed as pre-perimetric glaucoma. Group III: patients with diagnosed perimetric glaucoma. After patients were selected on the basis of inclusion and exclusion criteria, baseline standard ophthalmic examination was done by the same operator under the same settings, including SD-OCT using both the Spectralis SD-OCT and the Cirrus SD-OCT as elaborated below.Statistical Analysis: Data were checked for normality before statistical analysis using Shapiro–Wilk test. Normally distributed continuous variables were compared using ANOVA. For all statistical tests, a p < 0.05 was taken to indicate a significant difference. Receiver operating characteristic (ROC) curves were used to define the ability RNFL and GCC parameters to distinguish perimetric and preperimetric glaucomatous eyes from control eyes.Results: There was a statistically significant difference in the average, superior, inferior RNFL thickness and average, superior, inferior GCIPL thickness between Group I and Group II (p< 0.001), between Group I and Group III (p< 0.001) and also between Group II and Group III (p< 0.001). The statistical significance was also reflected in their AUROCs.Conclusion: Mean, superior, inferior GCIPL thickness along with macular volume analysis can substantiate RNFL analysis for diagnosis, serial monitoring and follow-up of glaucoma patients and suspects.Keywords: RNFL, GCC, perimetric glaucoma, pre-perimetric glaucoma

Aastha Gandhi,1 Anuj Mehta,1 Mayuresh Naik2 1Department of Ophthalmology, V.M.M.C & Safdarjung Hospital, Ansari Nagar, New Delhi 110029, India; 2Department of Ophthalmology, H.I.M.S.R & H.A.H. Centenary Hospital, Alaknanda, New Delhi 110062, IndiaCorrespondence: Mayuresh NaikDepartment of Ophthalmology, H.I.M.S.R & H.A.H. Centenary Hospital, Room No. 3 of Eye OPD, 1st Floor of OPD Building, Near GK-2, Alaknanda, New Delhi 110062, IndiaTel +91-8287344576Email mayureshpnaik@gmail.comPurpose: To evaluate the effect of frontalis sling surgery for congenital ptosis on corneal curvature and refractive status.Methods: Prospective study of 60 eyes of 48 patients with severe simple congenital ptosis who underwent surgical correction by frontalis sling surgery. Assessment was done pre-operatively and at 1 week, 1 month, 3 months post-operatively by computerized topographer (Shipp Nippon, CT 1000), IOL master (Carl Zeiss, 500), autorefractometer (Unicos URK-800) and AS-OCT (Cirrus HD-OCT). The results were statistically evaluated to analyze any change in visual acuity, refractive status, keratometry, astigmatism and central corneal thickness (CCT).Results: Three months post-operatively, significant reduction of cylindrical power by − 0.358 D was observed by refraction with corresponding improvement of mean BCVA by 0.24± 0.04 logMAR. Corneal topography showed reduction in astigmatism by − 0.47± 0.95 D; however, the average keratometry did not undergo a significant change. The mean values of astigmatism by IOL master and topographer were comparable. There was significant steepening of the previously flatter meridian (horizontal meridian, in 63.3% patients) while the steeper meridian remained relatively unchanged. A greater reduction in astigmatism was noticed in children in the age group of 5– 10 years.Conclusion: Ptosis surgery modifies the corneal curvature, restoring corneal symmetry and reducing astigmatism; thus changing the refractive status of the patient, which needs to be addressed post-operatively to improve the quality of vision. Children with severe ptosis may benefit from being operated at an early age to achieve better astigmatic reduction.Keywords: topography, ptosis surgery, IOL master

An enzyme linked immunosorbent assay (ELISA), based on sheep hydatid cyst fluid antigen was used for the detection of specific antibodies of IgG, IgM, IgE and IgG subclass in the serum samples of 62 clinically and radiologically diagnosed cystic echinococcosis (CE) patients, 8 clinically suspected cases of CE, 25 other parasitic disease controls and 25 healthy controls. The diagnostic sensitivity in the clinically and radiologically suggestive cases (n = 62) for IgG antibody detection was highest (93 %), followed by IgE, IgG4, IgG1, IgG2, IgM and IgG3 with 89 %, 87 %, 85 %, 76 %, 70 % and 55 % respectively. The detection of specific IgE, IgG1 and IgG4 antibody showed the higher diagnostic sensitivity and specificity to the extent that they can be safely used as better substitute to IgG. Even though, the diagnostic sensitivity of IgG was highest (93%) but was less specific (88 %) due to the frequent non-specific reactions in the sera of patients with other parasitic infections and healthy controls. None of the sera samples from healthy controls gave non-specific reaction with IgE, IgG1 and IgG4 and there was a considerably reduced cross-reaction with these antibodies. The most discriminatory and specific antibodies found in this study belonged to IgE, IgG1 and IgG4; therefore, these antibodies may serve as useful diagnostic markers for CE.

Ajay S Chandanwale,1 Subramanian Sundar,2 Kaliaperumal Latchoumibady,3 Swati Biswas,4 Mukesh Gabhane,4 Manoj Naik,5 Kamlesh Patel4 1Department of Orthopedics & Traumatology, Byramjee Jeejeebhoy Medical College and Sassoon General Hospital, Pune, Maharashtra, India; 2Vasantha Subramanian Hospital, Chennai, Tamil Nadu, India; 3Vijay Hospital, Pondicherry, India; 4Medical Services Department, 5Clinical Research Department, Abbott Healthcare Pvt Ltd, Mumbai, India Objective: We aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of tramadol and diclofenac versus a standard approved FDC of tramadol and paracetamol, in patients with acute moderate to severe pain. Methods: A total of 204 patients with moderate to severe pain due to acute musculoskeletal conditions (n=52), acute flare of osteoarthritis (n=52), acute flare of rheumatoid arthritis (n=50), or postoperative pain (n=50) were enrolled in the study at baseline. Each disease category was then randomized to receive either of two treatments for 5 days: group A received an FDC of immediate-release tramadol hydrochloride (50 mg) and sustained-release diclofenac sodium (75 mg) (one tablet, twice daily), and group B received an FDC of tramadol hydrochloride (37.5 mg) and paracetamol (325 mg) (two tablets every 4–6 hours, up to a maximum of eight tablets daily). The primary efficacy end points were reductions in pain intensity from baseline at day 3 and day 5 as assessed by a Visual Analog Scale (VAS) score. Results: Group A showed a significant reduction in the VAS score for overall pain from baseline on day 3 (P=0.001) and day 5 (P

The Hybrid Recoil mass Analyzer (HYRA) operated in gas-filled mode has recently been coupled with the TIFR 4π spin spectrometer at IUAC, New Delhi to carry out spin (or angular momentum) distribution of heavy residues from fusion-evaporation reactions and spin gated GDR measurements. The details of the combined facility, initial experiments on evaporation residue tagged γ-multiplicity and the extraction of average transmission efficiency of HYRA are elaborated.