| CTRI Number |
CTRI/2026/02/102658 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the effectiveness of local numbing injections around the eye during corneal transplant surgery in corneal ulcers |
|
Scientific Title of Study
|
Assessment of Efficacy of Peribulbar Anesthesia for Therapeutic Keratoplasty and the Risk Factors associated with Poor Intraoperative Anesthesia for Therapeutic Penetrating Keratoplasty and its Outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen Radhakrishnan |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
Cornea Clinic, Room number 25, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry -605007 Cornea Clinic, Room number 25, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry -605007 Pondicherry PONDICHERRY 605007 India |
| Phone |
9486199789 |
| Fax |
|
| Email |
naveen@aravind.org |
|
Details of Contact Person Scientific Query
|
| Name |
Sunil Kumar K |
| Designation |
Fellow |
| Affiliation |
Aravind Eye Hospital |
| Address |
Cornea Clinic, Room number 25, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry -605007 Cornea Clinic, Room number 25, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry -605007 Pondicherry PONDICHERRY 605007 India |
| Phone |
8861373533 |
| Fax |
|
| Email |
drsunilkumark5550@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sunil Kumar K |
| Designation |
Fellow |
| Affiliation |
Aravind Eye Hospital |
| Address |
Cornea Clinic,Room number- 25, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry -605007 Cornea Clinic, Room number- 25, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry -605007 Pondicherry PONDICHERRY 605007 India |
| Phone |
8861373533 |
| Fax |
|
| Email |
drsunilkumark5550@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
Cuddalore Main Road, Thavalakuppam, Pondicherry - 605007 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sunil Kumar K |
Aravind Eye Hospital |
Cornea Clinic, Room number 25, Cuddalore Main Road, Thavalakuppam, Pondicherry Pondicherry PONDICHERRY |
8861373533
drsunilkumark5550@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Corneal ulcers of any etiology requiring therapeutic penetrating keratoplasty
2. Patients with prior history of Therapeutic keratoplasty requiring repeat therapeutic keratoplasty for graft re- infection or graft melt
|
|
| ExclusionCriteria |
| Details |
1. Patients undergoing cosmetic or optical penetrating keratoplasty
2. Patients with Cognitive impairment
3. Deaf and Mute patients
4. Pregnant and Lactating women
5. Patients on long term anxiolytic agents / other Psychiatric illness
6. Patients who lacked insight and unwilling to participate in the study.
7. Patients requiring general anesthesia for Therapeutic penetrating keratoplasty.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of patients having poor intraoperative analgesia
2. Number of patients developing intraoperative complications during therapeutic keratoplasty
3. Number of patients requiring repeat intra-operative local anesthesia
|
Baseline. Outcome measures are assessed intra-operatively. There are no follow-ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
12/02/2026 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 penetrating keratoplasty is a corneal transplant procedure performed to treat non-healing corneal ulcers and corneal ulcers with perforation with an aim to eliminate the infective foci and maintain the integrity of the globe. This complex surgery typically lasts between 30 minutes and 1.5 hours. The type of anesthesia used for therapeutic keratoplasty can vary, ranging from local anesthesia (such as retrobulbar, peribulbar, or sub-tenon anesthesia) to general anesthesia.1 Some case series have also reported performing penetrating keratoplasty under topical anesthesia with sedation in situations where local and general anesthesia were contraindicated.2 During penetrating keratoplasty, the eye is kept open for a brief period following removal of the diseased host tissue until placement of the donor corneal tissue, which increases the risk of positive vitreous pressure (PVP). PVP is associated with lens expulsion, posterior capsular rupture, vitreous loss and devastating suprachoroidal expulsive hemorrhage.3 Poor ophthalmic anesthesia results in incomplete akinesia and inadequate analgesia which are independent risk factors for PVP. This is followed by lack of patient co-operation, intra-operative anxiety and continuation of surgery difficult. Intraoperative anxiety can precipitate systemic complications like pulmonary edema, cardiac crisis or a stroke. In this study, we aim to analyze the efficacy of peribulbar anesthesia in therapeutic penetrating keratoplasty and the ocular risk factors associated with poor anesthesia and its clinical outcomes |