| CTRI Number |
CTRI/2025/08/092831 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective exploratory trial |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Confocal Imaging for Infectious Scleritis |
|
Scientific Title of Study
|
InVivo Confocal microscopy on Infectious Scleritis |
| Trial Acronym |
NIL |
|
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, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus, VSPC Building,Ground Floor,Room 02, Cornea Diagnostics,L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad 500 034
Hyderabad
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus, VSPC Building,Ground Floor,Room 02, Cornea Diagnostics,L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad 500 034
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus, VSPC Building,Ground Floor,Room 02, Cornea Diagnostics,L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad 500 034
TELANGANA
500034
India |
| Phone |
9618276424 |
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute
Kallam Anji Reddy Campus, VSPC Building,Ground Floor,Room 02, Cornea Diagnostics,L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad 500 034
|
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus, GPR Building,L V Prasad Marg, Banjara Hills, Road No:02,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, VSPC Building,Ground Floor,Room 02, Cornea Diagnostics,L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad 500 034
Hyderabad
TELANGANA |
9618276424
bhupesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H150||Scleritis, (2) ICD-10 Condition: H150||Scleritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.All age groups with adequate cooperation
2.Clinically diagnosed cases of scleritis with suspected infectious aetiology
|
|
| ExclusionCriteria |
| Details |
1.Excessive ocular discharge
2.Severe conjunctival chemosis
3.Corneal perforation or extreme corneal and scleral thinning
4.Significant eyelid abnormality that interferes with imaging (e.g., severe entropion, ectropion, blepharospasm)
5.History of tarsorrhaphy (partial or complete), unless lid separation is possible and scleral area is accessible for imaging.
6.Known allergy to topical anaesthetic drops.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Able to diagnose infective organism in patients of infectious scleritis |
1 week , 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare with microbiology |
1 day and 1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/08/2025 |
| 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="1"
Days="1" |
|
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
|
A topical anesthetic (Paracain) will be applied to ensure comfort. After explaining the procedure, subjects will be positioned at the chinrest and instructed to fixate on a light source. IVCM will then be used to image the sclera in all four quadrants in Both eyes, focusing on clinically affected areas. Images will be stored for subsequent analysis. |