| CTRI Number |
CTRI/2025/09/094133 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of clinical and pathological findings in patients undergoing therapeutic corneal transplant |
|
Scientific Title of Study
|
Clinicopathological correlation in therapeutic keratoplasty |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| New Id |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ATMAKURU SAI SIVANI |
| Designation |
PG student |
| Affiliation |
sankara eye hospital ,guntur |
| Address |
GENERAL OPHTHALMOLOGY, CORNEA DEPARTMENT, SANKARA EYE HOSPITAL, GUNTUR VIJAYAWADA HIGHWAY,PEDAKAKANI,GUNTUR,ANDHRA PRADESH.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
6301599710 |
| Fax |
|
| Email |
shivaniatmakuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VELURI HARITHA |
| Designation |
CORNEA CONSULTANT |
| Affiliation |
sankara eye hospital,guntur |
| Address |
CORNEA DEPARTMENT,ROOM NO-127,SANKARA EYE HOSPITAL, GUNTUR VIJAYAWADA HIGHWAY,PEDAKAKANI,GUNTUR,ANDHRA PRADESH
Guntur
ANDHRA PRADESH
2522509
India |
| Phone |
6301133957 |
| Fax |
|
| Email |
harithaveluri@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
VELURI HARITHA |
| Designation |
CORNEA CONSULTANT |
| Affiliation |
sankara eye hospital,guntur |
| Address |
CORNEA DEPARTMENT, ROOM NO -127,SANKARA EYE HOSPITAL, GUNTUR VIJAYAWADA HIGHWAY,PEDAKAKANI,GUNTUR,ANDHRA PRADESH
ANDHRA PRADESH
2522509
India |
| Phone |
6301133957 |
| Fax |
|
| Email |
harithaveluri@sankaraeye.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital, guntur,522509,Andhra Pradesh, India
|
|
|
Primary Sponsor
|
| Name |
DrAtmakuru Sai Sivani |
| Address |
Sankara eye hospital, guntur- Vijayawada highway,pedakakani,guntur,522509,Andhra pradesh,India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAtmakuru sai sivani |
Sankara eye hospital |
Room no 127,cornea department, Ophthalmology division,Sankara eye hospital, guntur-Vijayawada highway,pedakakani,guntur,Andhra Pradesh
Guntur
ANDHRA PRADESH |
6301599710
shivaniatmakuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Sankara Eye Hospital-Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Therapeutic keratoplasty |
Preop cultures and staining reports collected followed by therapeutic keratoplasty and culture and histopathology of obtained corneal button .This includes time period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Corneal ulcers of fungal,bacterial or acanthamoeba etiology, not responding to or showing progression despite a minimum of 2 weeks of medical therapy at our institute
Corneal ulcer with impending perforation
Perforated corneal ulcer more than 3mm
Patients who give consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with corneal ulcer caused by viruses
Perforated corneal ulcer less than 3mm
Patients age less than 15 or more than 70 with systemic conditions
Infectious keratitis with endophthalmitis or panophthalmitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of staining and culture reports preop with culture and histopathology reports of corneal button postop |
Preop and postop 1week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess predisposing factors for non healing infectious keratitis |
Preop 1week |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Infectious keratitis is a major cause of blindness worldwide.Though medical therapy is the first line of management ,some cases which are resistant to therapy and progress require therapeutic keratoplasty.Outcome of tkp depends on various factors one of which is identification of causative organism which guides in postoperative therapy and reduces the chance of recurrence. Corneal scrapings followed by staining and culture are standard diagnostic tools.cases where etiology is not clear, microbiological and histopathological analysis of host corneal button obtained during TKP reveals organisms missed by staining and culture.This study aims to evaluate how well the clinical findings match with microbiological and histopathological results in patients undergoing therapeutic keratoplasty. Understanding this correlation helps us in guiding proper treatment, reduce graft failure and improve visual outcome in severe infectious keratitis. |