Usage of Cornea in Tympanoplasty: A Prospective Study

Original Article Iranian Journal of Otorhinolaryngology, Vol.37(5), Serial No.142, Sep-2025 Usage of Cornea in Tympanoplasty: A Prospective Study Sphoorthi Basavannaiah1 Abstract Introduction: CSOM is inflammation of the mucoperiosteal lining of the ME cleft characterized by ear discharge, permanent perforation of the TM, and hearing impairment. If perforation fails to heal, surgical closure is done by M-plasty (Type-I T-plasty). The graft material used to reconstruct the eardrum is mainly TF. The goal is to reconstruct the TM and sound-conducting mechanism in a long-lasting way. Here, in this study, corneal homograft was considered for closure of TM perforation as part of primary T-plasty. To utilize unused cornea as homograft in T-plasty for closure of TM perforation and obtain acoustic qualities similar to normal TM. Materials and Methods: 63 pts with TTD of ME in a hospital setup over a period of 2 years were considered for the study. All underwent T-plasty with use of Cornea and results were interpreted based on operative graft uptake and effective audible acoustics. Results: 88% of patients showed successful corneal graft uptake, while 12% of patients with failed corneal graft uptake were planned for revision surgery with other graft materials. A literature review was done with a comparison in terms of various graft materials used to date, success of graft uptake, and audibility achieved following closure of TM perforation. Conclusion: Corneal graft has shown fairly significant results in terms of efficacious graft uptake and efficient hearing acoustics after T-plasty. Keywords: Cornea, Graft, Middle Ear Surgery, Tympanic Membrane, Tympanoplasty, Temporalis Fascia. Received date: 14 Nov 2024 Accepted date: 30 Jun 2025 *Please cite this article; Basavannaiah S. Usage of Cornea in Tympanoplasty: A Prospective Study. Iran J Otorhinolaryngol. 2025:37(5): 267-280. Doi: 10.22038/ijorl.2025.84081.3831 Department of ENT, Subbaiah Institute of Medical Sciences, Shimoga-577222, Karnataka, India. E-mail: Copyright©2025 Mashhad University of Medical Sciences. This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 International License https://creativecommons.org/licenses/by-nc/4.0/deed.en 267 Sphoorthi Basavannaiah Introduction M-plasty is a surgical procedure to repair TM and close perforation, first described by Berthold. Surgery involves the use of a graft as a scaffold for epithelium to grow over it and close the perforation. Later, it assumes normal ME mucosa with ossicular chain. The results of surgery depend on the success of graft uptake and hearing improvement. The function of the ME is to transmit sound waves from the outer environment to inner ear fluids, bridged by the TM and ossicular chain. TM perforation is most commonly caused by ME infection. CSOM is one of the commonest causes of deafness in India (1). Keeping this in mind, this study primarily utilizes unused cornea from an eye bank as a homograft for closure of TM in a surgical procedure, i.e., cornea T-plasty, and to obtain neotympanum with acoustic qualities similar to that of normal TM following successful graft uptake. Materials and Methods Study design: Prospective follow-up study. Place of study: The study will be conducted at *****. Study period: 2 years. Selection criteria: All 63 pts with TTD of ME attending the outpatient department of ***** from October 2018 to September 2020 were taken up for surgery after history and detailed clinical examination as shown in attachments 1 and 2. The study was conducted after obtaining Ethical clearance as shown in attachment 6. The Ethics Committee gave the official approval for the study in June 2020, which was delayed due to COVID, but the unofficial approval was obtained way before, after which the study was commenced. Also, the study involved merging both the ear and eye departments at different setups and multiple levels of agreement, which further delayed obtaining the approval. As this study involves association with the Eye Hospital, where the IRB is situated and the approval of the study was held and taken. In addition, the study also involved the permission from the Transplantation of Human Organs and Tissues Act with the Certificate number of Registration-JD/(H)/HOTA/19/2017-2018 for granting permission for approval on Eye Bank and Keratoplasty, plus the Certificate of Registration for Keratoplasty and Scleral Tissue Transplantation for Tympanoplasty with Registration-JD(M)/HOTA/32/2017-2018. While the informed consent for the study was taken from the patients as per attachment 3,4,5 and is provided as an attachment, which is usually the followed protocol at the hospital as part of the pre-operative checklist procedures for all emergency and elective cases. Material used: Cornea/Sclera not utilised for optical keratoplasty that is rejected in the eye banks is used as the graft material as per attachment 7, 8. It is a simplified method to make use of a corneal disc preserved in glycerine for closure of TM perforation. Here, the perforated drum is reconstructed using a corneal graft by the inlay method through a transcanal incision under local anesthesia. Inclusion criteria: • Adult male & female between 18 and 60 years of age. • Simple TM perforation with inactive ME mucosa. • TM perforation with no acute or chronic ME disease. • Ear to be dry for a minimum of 3 months. • Otitis media with normal facial nerve function. • Pts with conductive or mixed hearing loss on audiogram. Exclusion criteria: • Acute/chronic or active ME disease at the time of surgery. • Any acute or chronic nose/throat infections preoperatively for at least 3 months. • Children are excluded from the study. • Any alterations of hematological parameters. Procedure of the study: 63 pts with TTD of ME attending the outpatient department of ***** from October 2018 to September 2020 were taken up for surgery after a history and detailed clinical examination, and a provisional diagnosis was arrived at. All necessary investigations were done to attain a final confirmatory diagnosis 1. Otomicroscopic examination/otoendoscopy—to confirm the provisional diagnosis after the initial clinical evaluation and find out additional information pertaining to the diagnosis: middle ear mucosa, status of the ossicular chain and its patency, status of the round and oval windows along with the round 268 Iranian Journal of Otorhinolaryngology, Vol.37(5), Serial No.142, Sep-2025 CORNEA in Tympanoplasty window reflex, and taking a swab of ear discharge and sending it for culture and sensitivity for choice of antibiotics pre- as well as post-procedure. 2. Pure Tone Audiometry (PTA)—to know the type and degree of hearing loss as per the table mentioned below: if conductive, sensorineural, or mixed hearing loss, to assess the air-bone gap. The audiogram is one of the important prerequisites as part of medicolegal importance. The audiometry was done following standard protoc (...truncated)