Published April 30, 2023 | Version http://impactfactor.org/PDF/IJTPR/13/IJTPR,Vol13,Issue4,Article11.pdf

A Prospective Observational Study on the Clinical Characteristics of Pregnant Women Post COVID-19 Vaccines

  • 1. Department of Pharmacy Practice, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai

Description

Background: The use of mydriatic and cycloplegic eye drops is a common practice in ophthalmology for various diagnostic and therapeutic procedures like for estimation of refractive error and for thorough fundus examination. The combination of Tropicamide and Phenylephrine has been a subject of debate among ophthalmologists regarding its efficacy and side effects. Aims and Objectives: The aim of this study was to evaluate the efficacy and safety of 1% Tropicamide alone versus a combination of 0.8% Tropicamide and 5% Phenylephrine for mydriasis and cycloplegia. The objectives were to compare the rate of mydriasis and maximal mydriasis after instilling a single drop of each solution and to measure the degree of cycloplegia and amount of residual accommodation at 25 minutes after instillation of the drops. Methods: This was a hospital-based, analytic cross-sectional study conducted on 100 patients between 15 and 35 years of age presenting to the Department of Ophthalmology, Government Medical College and Associated Group of Hospitals, Kota for refraction or fundus examination. Patients were randomly assigned to either the Tropicamide group or the Tropicamide-Phenylephrine group. The study measured the rate of mydriasis, maximal mydriasis after eye drop instillation. Study also measured the degree of cycloplegia and amount of residual accommodation at 25 minutes after instillation of the drop. Results: The combination of Tropicamide and Phenylephrine resulted in a higher rate of mydriasis and maximal mydriasis than Tropicamide alone. Tropicamide alone uncovered significantly higher mean latent error of refraction and had higher cycloplegic effect as compared to combination group. The study also found that increasing age lead to increased cycloplegia and decreased residual accommodation in both groups. It was also found that both groups had a similar safety profile, with no significant adverse effects observed except significant increase in pulse rate after instillation of combination eye drop. Conclusion: The combination of Tropicamide and Phenylephrine is more effective than Tropicamide alone for inducing mydriasis with a similar safety profile except significant change in pulse rate. While Tropicamide alone had better cycloplegic effect.

Abstract (English)

Background: The use of mydriatic and cycloplegic eye drops is a common practice in ophthalmology for various diagnostic and therapeutic procedures like for estimation of refractive error and for thorough fundus examination. The combination of Tropicamide and Phenylephrine has been a subject of debate among ophthalmologists regarding its efficacy and side effects. Aims and Objectives: The aim of this study was to evaluate the efficacy and safety of 1% Tropicamide alone versus a combination of 0.8% Tropicamide and 5% Phenylephrine for mydriasis and cycloplegia. The objectives were to compare the rate of mydriasis and maximal mydriasis after instilling a single drop of each solution and to measure the degree of cycloplegia and amount of residual accommodation at 25 minutes after instillation of the drops. Methods: This was a hospital-based, analytic cross-sectional study conducted on 100 patients between 15 and 35 years of age presenting to the Department of Ophthalmology, Government Medical College and Associated Group of Hospitals, Kota for refraction or fundus examination. Patients were randomly assigned to either the Tropicamide group or the Tropicamide-Phenylephrine group. The study measured the rate of mydriasis, maximal mydriasis after eye drop instillation. Study also measured the degree of cycloplegia and amount of residual accommodation at 25 minutes after instillation of the drop. Results: The combination of Tropicamide and Phenylephrine resulted in a higher rate of mydriasis and maximal mydriasis than Tropicamide alone. Tropicamide alone uncovered significantly higher mean latent error of refraction and had higher cycloplegic effect as compared to combination group. The study also found that increasing age lead to increased cycloplegia and decreased residual accommodation in both groups. It was also found that both groups had a similar safety profile, with no significant adverse effects observed except significant increase in pulse rate after instillation of combination eye drop. Conclusion: The combination of Tropicamide and Phenylephrine is more effective than Tropicamide alone for inducing mydriasis with a similar safety profile except significant change in pulse rate. While Tropicamide alone had better cycloplegic effect.

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Additional details

Dates

Accepted
2023-03-30

References

  • 1. Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, et al. Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine. 2013; 31:4274–9. 2. Petousis-Harris H. Assessing the safety of COVID-19 vaccines: a primer. Drug safety. 2020; 43:1205- 10.https://www.fda.gov/media/139638/do wnload 3. UK Health Security Agency COVID-19 vaccine surveillance report. accessed 8 march 2022. https://www.gov.uk/government/publicati ons/covid-19-vaccine-weeklysurveillance-reports 4. Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young N, et al. Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. Am J Obstet Gynecol. 2021; 225: 303.e1-303.e17. 5. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med. 2021; 384:2273– 82. 6. Yang H, Wang C, Poon LC. Novel coronavirus infection and pregnancy. Ultrasound Obstet Gynecol. 2020; 55:435– 7. 7. Cheng VCC, Wong S-C, Chen JHK, Yip CCY, Chuang VWM, Tsang OTY, et al. Escalating infection control response to the rapidly evolving epidemiology of the coronavirus disease 2019 (COVID-19) due to SARS-CoV-2 in Hong Kong. Infect Control Hosp Epidemiol. 2020; 41:493–8. 8. Tay MZ, Poh CM, Rénia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020; 20:363–74. 9. Chen L, Li Q, Zheng D, Jiang H, Wei Y, Zou L, et al. Clinical characteristics of pregnant women with covid-19 in Wuhan, China. N Engl J Med. 2020; 382: e100. 10. Pan F, Yang L, Li Y, Liang B, Li L, Ye T, et al. Factors associated with death outcome in patients with severe coronavirus disease-19 (COVID-19): a case-control study. Int J Med Sci. 2020; 17:1281–92. 11. Li N, Han L, Peng M, Lv Y, Ouyang Y, Liu K, et al. Maternal and neonatal outcomes of pregnant women with Coronavirus disease 2019 (COVID-19) pneumonia: A case-control study. Clin Infect Dis. 2020; 71:2035–41. 12. Abu-Raya B. Vaccination of pregnant women against COVID-19. Neoreviews. 2021; 22: e570-3. 13. Eskenazi B, Rauch S, Iurlaro E, Gunier RB, Rego A, Gravett MG, et al. Diabetes mellitus, maternal adiposity, and insulindependent gestational diabetes are associated with COVID-19 in pregnancy: the INTERCOVID study. Am J Obstet Gynecol. 2022; 227: 74.e1-74. e16. 14. PM Modi launches Covid-19 vaccine drive in India: Key highlights from his speech. Last accessed 2021 Jan 23 Available online from: www.hindustantimes.com 15. Dagan N, Barda N, Biron-Shental T, Makov-Assif M, Key C, Kohane IS, et al. Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy. Nat Med. 2021; 27:1693–5. 16. Goldshtein I, Nevo D, Steinberg DM, Rotem RS, Gorfine M, Chodick G, et al. Association between BNT162b2 vaccination and incidence of SARS-CoV2 infection in pregnant women. Jama. 2021; 326:728-35. 17. Khraif R, Abdul Salam A, Al-Mutairi A, Elsegaey I. Fertility behaviour of working women in Saudi Arabia: a special case of King Saud University, Riyadh. Hum Fertil (Camb). 2019; 22:246–54. 18. Skjefte M, Ngirbabul M, Akeju O, Escudero D, Hernandez-Diaz S, Wyszynski DF, et al. COVID-19 vaccine acceptance among pregnant women and mothers of young children: results of a survey in 16 countries. Eur J Epidemiol. 2021; 36:197–211. 19. Prevention, C.f.D.C.a. Vaccine safety; 2021: https://www.who.int/newsroom/feature-stories/detail/safety-ofcovid-19-vaccines 20. Ortiz EI, Herrera E, De La Torre A. Coronavirus (COVID-19) infection in pregnancy. Colomb Med. 2020; 51: e4271