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CTRI Number  CTRI/2026/01/102619 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A clinical trial to study the causative factors for Corneal tissue Infections After Transplantation in Corneal Ulcer 
Scientific Title of Study   Corneal Donor and Patient Related Factors Influencing Graft Infection in Therapeutic Keratoplasty: A clinical, surgical and microbiological Analysis 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejaswi Prasad P V 
Designation  Assistant Professor 
Affiliation  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology  
Address  Cornea Service Department Room No 314 3rd Floor OPD Block
No 1 Anna Nagar Madurai TAMIL NADU
Madurai
TAMIL NADU
625020
India 
Phone  914524356100  
Fax    
Email  tejaswiprasadpv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejaswi Prasad P V 
Designation  Assistant Professor 
Affiliation  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology  
Address  Cornea Service Department Room No 314 3rd Floor OPD Block
No 1 Anna Nagar Madurai TAMIL NADU
Madurai
TAMIL NADU
625020
India 
Phone  914524356100  
Fax    
Email  tejaswiprasadpv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejaswi Prasad P V 
Designation  Assistant Professor 
Affiliation  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology  
Address  Cornea Service Department Room No 314 3rd Floor OPD Block
No 1 Anna Nagar Madurai TAMIL NADU
Madurai
TAMIL NADU
625020
India 
Phone  914524356100  
Fax    
Email  tejaswiprasadpv@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology Cornea Service Department Room No 314 3rd Floor OPD Block No 1 Anna Nagar Madurai TAMIL NADU Madurai TAMIL NADU 625020 India  
 
Primary Sponsor  
Name  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology 
Address  Cornea Service Department Room No 314 3rd Floor OPD Block No 1 Anna Nagar Madurai 625020 TAMIL NADU India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejaswi Prasad P V  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology   Cornea Services Department Room No 314 3rd Floor OPD Block No 1 Anna Nagar
Madurai
TAMIL NADU 
914524356100

tejaswiprasadpv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a)Non healing microbial keratitis bacterial fungal or parasitic unresponsive to standard medical therapy for 2 weeks or earlier in case of advanced ulcer
b)Corneal perforation of more than 2mm in size due to infectious cause
c)Descemetocele leading to impending perforation of the cornea
d)Advanced corneal ulcers size of more than 5mm and involving the posterior two thirds of the corneal stroma 
 
ExclusionCriteria 
Details  a)Patients with viral keratitis
b)Cases where the primary diagnosis is not microbial keratitis
c)Infectious infiltration involving the limbus or sclera
d)Patients with a history of corneal surgery within the 12 months preceding the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is the incidence of graft infections following TPK within the first 3 months post-transplantation. This will be quantified as the proportion of patients who develop a confirmed graft infection during this period.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 

1. Time to onset of graft infection: The time interval between TPK and the diagnosis of the first graft infection. 2. Impact of donor-related variables on infection rates: The association between donor age, cause of death, death-to-preservation time, location of corneal retrieval, and method of preservation/transport, and the occurrence of post-TPK graft infections. 3. Influence of preoperative microbial flora on postoperative graft outcomes: The relationship between the microorganisms identified on preoperative corneal cultures and the subsequent development of graft infections, as well as the overall anatomical and visual outcomes of TPK 
12 months 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Therapeutic keratoplasty (TPK) is a surgical procedure used to treat advanced, refractory microbial keratitis, due to failed medical management, and perforation. TPK is the last resort to remove the infected tissue and replace it with a healthy donor cornea. The primary goal of TPK is to eliminate the active infectious process, restore the structural integrity of the globe, and prevent complications such as phthisis bulbi and endophthalmitis. In regions where microbial keratitis is more prevalent, particularly in developing countries, TPK is frequently performed to address refractory or advanced bacterial, fungal, and parasitic corneal infections.

However, therapeutic keratoplasty is associated with significant challenges despite its critical role in halting disease progression. Postoperative complications, such as graft infection pose substantial risks to the success of the procedure, which may lead to corneal melt, secondary glaucoma, anatomical failure, anterior staphyloma, and phthisis bulbi. Fungal keratitis has been shown to have higher recurrence rates compared to bacterial infections, complicating the management of these patients. TPK requires not only precise surgical intervention but also meticulous postoperative care to minimise complications and ensure the long-term viability of the graft.

There are several notable research gaps in the current understanding of TPK outcomes. First, there is limited knowledge regarding the specific causes of infection recurrence, particularly in cases involving fungal keratitis. Preoperative conditions, such as corneal perforation and the presence of hypopyon, have been implicated as risk factors, but the exact mechanisms remain unclear. Second, the quality of donor material used in TPK can vary significantly, particularly in resource-limited settings where high-quality corneas are scarce. Finally, there is a need for standardised postoperative antimicrobial protocols. While prophylactic antiviral treatments are well-established for viral keratitis, optimal regimens for bacterial and fungal infections remain inconsistent across institutions.

Addressing these research gaps is crucial to improving the outcomes of therapeutic keratoplasty. Understanding the causes of graft infection could lead to more effective preoperative risk assessments and targeted interventions. Further investigation into the impact of donor cornea quality would provide valuable insights into optimising donor selection and tissue preservation techniques. Additionally, research focused on developing standardised postoperative antimicrobial protocols would help reduce the variability in treatment outcomes and improve overall graft survival rates. To address these concerns, a comprehensive study must be conducted that examines the clinical, microbiological, and procedural factors influencing the success of TPK.

Hence, we aim to investigate the clinical and microbiological factors that influence the success of therapeutic keratoplasty in managing advanced microbial keratitis, focusing on identifying the risk factors for graft infection and addressing the existing gaps in postoperative care and donor material quality.

 
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