EFFECTIVENESS AND SAFETY OF AMNIOTIC MEMBRANE GRAFTING FOR CORNEAL SURFACE DISORDER: A RANDOMIZED CLINICAL STUDY

Authors

  • Pawan Kumar Yadav Department of Ophthalmology, Saraswati Medical College, Unnao, Uttar Pradesh, India.
  • Ajay Kumar Arya Department of Ophthalmology, Mayo Institute of Medical Sciences, Barabanki, Uttar Pradesh, India.
  • Aparna Shukla Centre for Advance Research (CFAR), King George’s Medical University, Lucknow, Uttar Pradesh, India.

DOI:

https://doi.org/10.22159/ajpcr.2024.v17i3.49343

Keywords:

amniotic membrane grafting, corneal surface disorders, healing time, visual acuity, recurrence rate, corneal clarity, safety

Abstract

Objective: The aim of the study was to evaluate the effectiveness and safety of freeze-dried amniotic membrane grafting (AMG) and compare it against traditional medical therapy for the management of corneal surface disorders.

Methods: A randomized clinical trial was conducted on 60 patients with corneal surface disorders who were randomized equally either into the AMG group (n=30) or medical management group (n=30). Patients in both groups were followed up for 8 weeks after receiving group-specified intervention or till complete resolution (whichever was earlier). Treatment outcome, healing time, improved vision, decreased pain, recurrence rate, and corneal clarity were the main outcome metrics.

Results: The most common corneal disorder was persistent epithelial defect (38.33%), closely followed by impending perforated corneal ulcer (31.66%). Majority of the patients (36.66%) had corneal involvement of >75%, while 31.66% had involvement ranging from 50 to 75%. The success rate of AMG (96.7%) was significantly higher than that of medical management (76.7%) in the treatment of corneal surface disorders (p=0.022). During the follow-up period, the incidence of allergic reactions was slightly lower in the AMG group (6.7%) compared to the medical management group (10.0%). Overall, the incidence of side effects and other complications was low in both the AMG group and the medical management group. The severity of side effects was comparable in both the study groups (p=0.886). The recurrence rate of corneal surface disorders in the in the AMG group (6.7%) was statistically lower than that in the medical management group (26.7%) (p=0.037).

Conclusion: The findings of the present study supported the use of AMG as an effective and safe alternative to medical management for the treatment of conditions affecting the corneal surface.

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Author Biographies

Pawan Kumar Yadav, Department of Ophthalmology, Saraswati Medical College, Unnao, Uttar Pradesh, India.

Assistant Professor, Dept of Ophthalmology

Ajay Kumar Arya, Department of Ophthalmology, Mayo Institute of Medical Sciences, Barabanki, Uttar Pradesh, India.

Assistant Professor, Dept of Ophthalmology

References

Miller DD, Hasan SA, Simmons NL, Stewart MW. Recurrent corneal erosion: A comprehensive review. Clin Ophthalmol 2019;13:325-35.

Zhang L, Coulson-Thomas VJ, Ferreira TG, Kao WW. Mesenchymal stem cells for treating ocular surface diseases. BMC Ophthalmol 2015;15:155.

Tan DT, Dart JK, Holland EJ, Kinoshita S. Corneal transplantation. Lancet 2012;379:1749-61.

Azuara-Blanco A, Pillai CT, Dua HS. Amniotic membrane transplantation for ocular surface reconstruction. Br J Ophthalmol 1999;83:399-402.

Liu J, Sheha H, Fu Y, Liang L, Tseng SC. Update on amniotic membrane transplantation. Expert Rev Ophthalmol 2010;5:645-61.

Tseng SC, Espana EM, Kawakita T, Di Pascuale MA, Li W, He H, et al. How does amniotic membrane work? Ocul Surf 2004;2:177-87.

Gujjar S, Venkataprasanna KS, Tiwari S, Sharma JC, Sharma P, Pujani M, et al. Stabilized human amniotic membrane for enhanced sustainability and biocompatibility. Process Biochem 2023;129:67-75.

Dua HS, Gomes JA, King AJ, Maharajan VS. The amniotic membrane in ophthalmology. Surv Ophthalmol 2004;49:51-77.

Crawford AZ, Patel DV, McGhee CN. A brief history of corneal transplantation: From ancient to modern. Oman J Ophthalmol 2013;6:S12-7. doi: 10.4103/0974-620X.122289

Stamate AC, Tătaru CP, Zemba M. Update on surgical management of corneal ulceration and perforation. Rom J Ophthalmol 2019;63:166-73.

Sangwan VS, Burman S, Tejwani S, Mahesh SP, Murthy R. Amniotic membrane transplantation: A review of current indications in the management of ophthalmic disorders. Indian J Ophthalmol 2007;55:251-60.

Nakamura T, Sekiyama E, Takaoka M, Bentley AJ, Yokoi N, Fullwood NJ, et al. The use of trehalose-treated freeze-dried amniotic membrane for ocular surface reconstruction. Biomaterials 2008;29:3729-37.

Byrd LB, Martin N. Corneal ulcer. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. Available from: https://www.ncbi.nlm.nih. gov/books/Nbk539689 [Last accessed on 2022 Aug 08].

Meller D, Pauklin M, Thomasen H, Westekemper H, Steuhl KP. Amniotic membrane transplantation in the human eye. Dtsch Arztebl Int 2011;108:243-8. doi: 10.3238/arztebl.2011.0243

Seitz B. Amniotic membrane transplantation. An indispensable therapy option for persistent corneal epithelial defects. Ophthalmologe 2007;104:1075-9.

Fuchsluger T, Tuerkeli E, Westekemper H, Esser J, Steuhl KP, Meller D. Rate of epithelialisation and re-operations in corneal ulcers treated with amniotic membrane transplantation combined with botulinum toxin-induced ptosis. Graefes Arch Clin Exp Ophthalmol 2007;245:955-64.

Thatte S. Amniotic membrane transplantation: An option for ocular surface disorders. Oman J Ophthalmol 2011;4:67-72. doi: 10.4103/0974-620X.83656

Lee SH, Tseng SC. Amniotic membrane transplantation for persistent epithelial defects with ulceration. Am J Ophthalmol 1997;123:303-12.

Eslami F, Alizadeh M, Ali Seifrabiei M, Mohebi Emam N. Comparison of amniotic membrane transplantation and conjunctival autograft transplantation for the treatment of pterygium. Avicenna J Clin Med 2019;25:215-21.

Shimazaki J, Shinozaki N, Tsubota K. Transplantation of amniotic membrane and limbal autograft for patients with recurrent pterygium associated with symblepharon. Br J Ophthalmol 1998;82:235-40.

Letko E, Stechschulte SU, Kenyon KR, Sadeq N, Romero TR, Samson CM, et al. Amniotic membrane inlay and overlay grafting for corneal epithelial defects and stromal ulcers. Arch Ophthalmol 2001;119:659-63.

Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian AM. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cells Mater 2008;15:88-99.

Published

07-03-2024

How to Cite

Yadav, P. K., A. K. Arya, and A. Shukla. “EFFECTIVENESS AND SAFETY OF AMNIOTIC MEMBRANE GRAFTING FOR CORNEAL SURFACE DISORDER: A RANDOMIZED CLINICAL STUDY”. Asian Journal of Pharmaceutical and Clinical Research, vol. 17, no. 3, Mar. 2024, pp. 77-80, doi:10.22159/ajpcr.2024.v17i3.49343.

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