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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  
NIL 
 
Primary Sponsor  
Name  Aravind Eye Hospital 
Address  Cuddalore Main Road, Thavalakuppam, Pondicherry - 605007 
Type of Sponsor  Private hospital/clinic 
 
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 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  
Status 
Not Applicable 
 
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

 
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