| CTRI Number |
CTRI/2020/02/023394 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the success of corneal transplantation in fungal ulcer. |
|
Scientific Title of Study
|
Outcome of therapeutic keratoplasty in various fungal keratitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smruti Rekha Priyadarshini |
| Designation |
Consultant in Cornea & anterior segment |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
MTC Campus Patia Bhubaneswar
MTC Campus Patia Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
|
| Fax |
|
| Email |
drsmruti@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smruti Rekha Priyadarshini |
| Designation |
Consultant in Cornea & anterior segment |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
MTC Campus Patia Bhubaneswar
MTC Campus Patia Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
|
| Fax |
|
| Email |
drsmruti@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Narayan Suhan |
| Designation |
Co-I |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
MTC Campus Patia Bhubaneswar
MTC Campus Patia Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
|
| Fax |
|
| Email |
dineshsuh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hyderabad Eye Research Foundation
L V Prasad Eye Institute
MTC Campus, Patia
Bhubaneswar-751024
Odisha India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
MTC Campus
Patia
Bhubaneswar
751024
Odisha
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 Dinesh Narayan Suhan |
L V Prasad Eye Institute |
Department of Cornea
MTC Campus
Patia
Bhubaneswar
751024
Khordha
ORISSA |
9820265799
dineshsuh@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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who underwent a full-thickness keratoplasty for recalcitrant microbial keratitis between July 2018- January 2020
Patient included in the study based on
- culture positive / smear positive
- ½ corneal button showing growth of fungus in culture
|
|
| ExclusionCriteria |
| Details |
Keratitis other than fungal etiology
Posterior segment involvement
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome- Resolution of infection
|
July 2018- January 2020
post surgery 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence, Anatomical integrity, Best-corrected Visual acuity, adverse effects |
July 2018- January 2020
Post operative Day 1, week 1 week 3 and 6 week |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
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)
|
17/02/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study deals with the analysis
of outcome of Therapeutic penetrating
keratoplasty (TPK) in various fungal keratitis. A large number of these
patients present in very advanced stage like limbus to limbus involvement of
cornea, or present with perforation or many a times recalcitrant to medical
management. In such cases therapeutic keratoplasty act as a great help for
resolution of infection and to restore anatomical integrity. In this study we
plan to analyze anatomical integrity, resolution of infection, and outcome of
graft. Patients will be followed up postoperatively on day-1, 1 week, 3 weeks,
6 weeks, 3 months as per the criteria and the outcome noted. |