| CTRI Number |
CTRI/2022/06/043019 [Registered on: 06/06/2022] Trial Registered Prospectively |
| Last Modified On: |
03/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Steroids for postoperative keratoplasty for fungal keratities |
|
Scientific Title of Study
|
To compare the outcome of therapeutic penetrating keratoplasty for fungal keratitis with late vs immediate postoperative addition of topical corticosteroids. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant-Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus,Room No: 123,Clinical Research Department,1st Floor, GPR Building, L V Prasad Marg, Hyderabad 500 034
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102615 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant-Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus,Room No: 123,Clinical Research Department,1st Floor, GPR Building, L V Prasad Marg, Hyderabad 500 034
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102615 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant-Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus,Room No: 123,Clinical Research Department,1st Floor, GPR Building, L V Prasad Marg, Hyderabad 500 034
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102615 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
Kallam Anji Reddy Campus, GPR Building, 1st floor, Clinical Research Departemnt, Room No: 123,L V Prasad Marg, Hyderabad 500 034
|
| Type of Sponsor |
Other [Non profitable organization] |
|
|
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 |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
Kallam Anji Reddy Campus, GPR Building, 1st floor, Clinical Research department, Room No:123,L V Prasad Marg, Hyderabad 500 034
Hyderabad
TELANGANA |
04068102615
bhupesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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
|
| Type |
Name |
Details |
| Intervention |
Topical corticosteroids |
Topical corticosteroids will be added along with the anfungus first day after the transplant done for fungal keratities.
Both the groups will receive topical Natamycin 5% every 1 hourly for 2 weeks along with oral Tab Ketoconazole 200 mg twice a day. |
| Comparator Agent |
Anti fungus |
Standard antifungal treatment will be given
Both the groups will receive topical Natamycin 5% every 1 hourly for 2 weeks along with oral Tab Ketoconazole 200 mg twice a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases with microbiologically confirmed fungal keratitis undergoing therapeutic keratoplasty for worsening of infection.
2.Size of infiltrate less or equal to 10 mm.
3.Intraoperative no evidence of residual infection
4.Immediate Post operative anterior chamber formed and no clinical evidence of infection
5.Use of MK medium corneal tissue of any grade with or with out intact epithelium
6.Intraoperative Preserved lens
7.Ready to give consent
8.Consent for regular follow-up
9.More than 18 years
10.Surgery performed by surgeons with experience of performing more than 20 TPK.
|
|
| ExclusionCriteria |
| Details |
1.Any evidence of intraop or clinical post-operative infection
2.Size of infiltrate > 10 mm
3.Not willing to come for regular follow-up or admission or giving consent
4.Disorganized anterior chamber
5.Posterior segment involvement as confirmed on Echoes in the posterior segment on B scan
6.Intraoperative presence of retero-iris and lens exudates.
7.Presence if corneal perforation before the surgery
8.Presence of uncontrolled diabetes or any other cause of decreased imununity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Graft survival rate at 6 months in both the groups and compared. |
3, 7,14, 30 days, 3 , 6 months and 1 year of follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients having recurrence of similar infection with in 2 weeks of surgery. |
3, 7,14, 30 days, 3 , 6 months and 1 year of follow-up |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
10/06/2022 |
| 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="1"
Days="1" |
|
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)?
Response - NO
|
|
Brief Summary
|
Prospective candidates for the study will be required to review and
understand the appropriate Informed
Consent Form, approved by the Institutional Review Board of LVPEI.
All subjects with proven fungal keratitis who underwent TPK,
suitable according the inclusion criteria will be enrolled and randomized into
two groups as per a computer-generated list to receive either (Group A) topical
corticosteroids with continuation of antifungals both topically and oral or continuation
of only antifungals alone for 2 weeks with later addition of corticosteroids
(Group B). The patients of both the
groups will be followed up regularly every 3, 7,14, 30 days, 3 , 6 months and 1
year of follow-up.
At the end of the study, there will be evaluation of both the groups
were compared in terms of graft survival and recurrence of infection as primary
and secondary outcome measures.
The graft survival is clinically defined as clear and compact
corneal graft at the end of six months of follow up.
Recurrence of infection is defined as microbiologically confirmed (either
by corneal scraping of the infiltrate or anterior chamber aspiration)
recurrence of similar infection on the graft.
All patients will also receive 1% atropine sulphate ophthalmic
solution to reduce intraocular inflammation and prevent synechiae.
Anti-glaucoma medication may be added if required. The atropine will be
administered to the affected eye(s) thrice a day.
|