| 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
|
|
|
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
|
|
|
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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