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A clinical trial to study the causative factors for Corneal tissue Infections After Transplantation in Corneal Ulcer

Corneal Donor and Patient Related Factors Influencing Graft Infection in Therapeutic Keratoplasty: A clinical, surgical and microbiological Analysis - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/102619
Enrollment
138
Registered
2026-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H188- Other specified disorders of cornea

Interventions

Intervention1: Nil: Nil

Sponsors

Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 12 months

Secondary

MeasureTime frame
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 TPKTimepoint: 12 months

Countries

India

Contacts

Public ContactDr Tejaswi Prasad P V

Aravind Eye Hospital and Postgraduate Institute of Ophthalmology

tejaswiprasadpv@gmail.com914524356100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026