| CTRI Number |
CTRI/2024/11/077473 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Eye changes review in Eye tissue |
|
Scientific Title of Study
|
Multi-omics Strategies to Improve Clinical Outcomes in Uveitis
LOTUS – Leveraging Ocular Tissues in Uveitis Study |
| Trial Acronym |
LOTUS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rathinam Sivakumar |
| Designation |
Chief Uvea Services |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Uvea Services
Room No 250
Second Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
rathinam@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rathinam Sivakumar |
| Designation |
Chief Uvea Services |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Uvea Services
Room No 250
Second Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
rathinam@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathinam Sivakumar |
| Designation |
Chief Uvea Services |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Uvea Services
Room No 250
Second Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
rathinam@aravind.org |
|
|
Source of Monetary or Material Support
|
| Proctor Foundation
University of California San Francisco
490 Illinois Street
Floor 2 San Francisco
CA 94158
USA |
|
|
Primary Sponsor
|
| Name |
Proctor Foundation University of California |
| Address |
Proctor Foundation
University of California
San Francisco
490 Illinois Street
Floor 2 San Francisco
CA 94158
USA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rathinam Sivakumar |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
Uvea Services
Room No 250
Second Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU |
914524356100
914522530984
rathinam@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Not applicable |
| Comparator Agent |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Intraocular samples
a) Presumed active infectious uveitis
b) Endophthalmitis
c) Unilateral or Bilateral
Tear samples
a) Active or inactive uveitis
b) Unilateral or Bilateral
|
|
| ExclusionCriteria |
| Details |
Intraocular samples
a) Insufficient sample size
b) Inability to give consent
Tear samples
a) Inability to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correct identification of the pathogen will change the treatment modality |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="300"
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)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
LOTUS is a study that combines
multimodality molecular approaches to improve the diagnosis of uveitis by
characterizing pathogens, host transcriptomes, the proteome and metaboite
signatures in uveitis. |