| CTRI Number |
CTRI/2020/03/024211 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
“Measuring and Treating Corneal Eye Infections.†|
|
Scientific Title of Study
|
Quantifying Microbial Keratitis to Predict Outcomes:
An Imaging and
Epidemiologic Approach |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Director of Academics, Chief of Cornea and Refractive Services |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Cornea Clinic
Room no 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356312 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Director of Academics, Chief of Cornea and Refractive Services |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Cornea Clinic
Room no 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356312 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Director of Academics, Chief of Cornea and Refractive Services |
| Affiliation |
Aravind Eye Hospital and PG Institute of Ophthalmology |
| Address |
Cornea Clinic
Room no 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356312 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
|
Source of Monetary or Material Support
|
| National Eye Institute at the National Institute of Health
31 Center Drive
Bethesda
MD - 20892-2510
USA |
|
|
Primary Sponsor
|
| Name |
National Eye Institute |
| Address |
National Eye Institute at the National Institute of Health
31 Center Drive
Bethesda
MD - 20892-2510
USA
|
| Type of Sponsor |
Government funding agency |
|
|
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 N Venkatesh Prajna |
Aravind Eye Hospital and PG Institute of Ophthalmology |
Cornea Clinic
Room no 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU |
914524356312
914522530984
prajna@aravind.org |
|
|
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: H161||Other and unspecified superficialkeratitis without conjunctivitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for cases
1) All participants must be aged above 15yrs and must be able to consent.
2) Clinically significant microbial keratitis more than or equal to 2 mm
Inclusion Criteria for controls
1) Non-infectious inflammatory keratitis, either immune mediated or contact lens related.
2) Patients could have had previous therapy by an outside provider |
|
| ExclusionCriteria |
| Details |
1) All participants aged <15yrs
2) Pregnancy
3) Prior incisional corneal surgery
4) No light perception vision
5) Corneal perforation/impending perforation
6) Viral keratitis
7) Acanthamoeba Keratitis
8) Difficulty coordinating timely study visits
9) Inpatient status
10) Institutional status |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To bring a validated tools to identify at-risk patients and to monitor patients with corneal infections |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict 90-Day eye health outcomes and to predict types of Corneal infections with substantial diagnostic accuracy The long term goal is to improve the initial and ongoing treatment for patients with corneal infections |
12 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="1000"
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)
|
01/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2020 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Imaging
to improve the quality of microbial keratitis is an International,
observational, case control study. The purpose of this study is to evaluate microbial
keratitis treatment efficacy using morphological and clinical features and to
create a risk stratification scoring system based on modelling of quantified
Imaging morphology and clinical data to the primary outcome of best corrected
visual acuity at 90 days.
We hypothesise that morphological and clinical features accurately risk
stratify patients for corneal and visual outcomes |