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CTRI Number  CTRI/2025/07/090777 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Risks and Eye Health After Eye Transplant Surgery: A Long-Term Study 
Scientific Title of Study   Assessment Of Risk Factors and Outcomes of Posterior Segment Complications Following Therapeutic Penetrating Keratoplasty- A Prospective Cohort Study 
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 Gokulvasanth D 
Designation  Primary DNB Resident 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room number 25, First Floor, Department of Cornea and Refractive services, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605 007, India

Pondicherry
PONDICHERRY
605007
India 
Phone  9500351393  
Fax    
Email  gokul30101999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naveen Radhakrishnan 
Designation  Consultant, Cornea and Refractive services 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room number 25, First Floor, Department of Cornea and Refractive services, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605 007, India

Pondicherry
PONDICHERRY
605007
India 
Phone  04132619200  
Fax    
Email  naveen@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Dr Gokulvasanth D 
Designation  Primary DNB Resident 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room number 25, First Floor, Department of Cornea and Refractive services, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605 007, India

Pondicherry
PONDICHERRY
605007
India 
Phone  9500351393  
Fax    
Email  gokul30101999@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605 007, India 
 
Primary Sponsor  
Name  Aravind Eye Hospital, Pondicherry 
Address  Room number 25, First Floor, Cornea and Refractive services, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605 007, 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 Gokulvasanth D  Aravind Eye Hospital, Pondicherry  Room number 25, First Floor, Department of Cornea and Refractive services, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605 007, India
Pondicherry
PONDICHERRY 
9500351393

gokul30101999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients 18 years and above who will be undergoing Therapeutic penetrating keratoplasty at Aravind Eye Hospital, Pondicherry 
 
ExclusionCriteria 
Details  Patients with pre-existing posterior segment will be excluded  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyse the incidence of posterior segment complications following Therapeutic penetrating keratoplasty  At the time of presentation,
Preoperative on the day of surgery,
Intraoperative,
Post operative Day 1,
Post operative Day 10,
Post operative Day 30,
Post operative Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the risk factors associated with the development of posterior segment complications post-TPK.   At the time of presentation,
Preoperative on the day of surgery,
Intraoperative,
Post operative Day 1,
Post operative Day 10,
Post operative Day 30,
Post operative Day 90. 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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)   21/07/2025 
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="9"
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 (TPK) is a surgical intervention performed to eliminate infection when medical treatment fails, primarily in cases of fungal keratitis. Corneal transplantation can be either full-thickness (penetrating keratoplasty) or partial-thickness (lamellar keratoplasty), with penetrating keratoplasty serving various purposes, including tectonic, therapeutic, cosmetic, and optical restoration. Corneal blindness affects approximately 1.5 to 2 million individuals annually, with corneal opacity accounting for 7.4% of blindness among individuals aged greater than  or equal to 50 years and 37.5 percent in those aged 0-49 years in India. Late diagnosis and delayed treatment frequently necessitate emergency TPK, which carries risks of intraoperative complications, including intraocular infection spread and expulsive choroidal hemorrhage, along with postoperative complications such as glaucoma, graft failure, retinal detachment, recurrent infection, and increased intraocular pressure. This study aims to analyze the incidence of posterior segment complications following TPK and identify associated risk factors. Patients aged 18 years and above undergoing TPK at Aravind Eye Hospital, Pondicherry, will be enrolled after providing written informed consent, while those with pre-existing posterior segment conditions will be excluded. Preoperative data collection will encompass demographic details, disease duration, keratitis type, prior keratoplasty history, visual acuity, intraocular pressure, and other infection-related parameters. Before surgery, patients will receive an intravenous infusion of 20% Mannitol (100 ml), followed by local anesthesia using facial and peribulbar blocks. The surgical procedure will be performed under continuous monitoring, with documentation of anesthesia details, intraoperative sedation, complications, and surgeon expertise. Postoperative assessments will take place on the 1st, 10th, 30th, and 90th days, covering parameters such as visual acuity, intraocular pressure, graft clarity, wound integrity, suture status, infection persistence, and posterior chamber complications. Additionally, information on resurgeries will be collected, noting the type and reasons. The operating surgeon will document details in the study proforma immediately after surgery. Study participants will remain anonymous, and all data will be used solely for academic purposes. This prospective cohort study aims to improve understanding of posterior segment complications following TPK, providing valuable insights to enhance patient outcomes and optimize treatment strategies for better postoperative recovery and complication prevention.

 
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