| 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
|
|
|
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
|
|
|
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. |