| CTRI Number |
CTRI/2021/01/030257 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
04/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in eye in the patients with red eye |
|
Scientific Title of Study
|
Topographic corneal changes in patients with Vernal keratoconjunctivitis-An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEH/PDY/EC/THESIS/65/2020 Version01 06/11/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poorani R |
| Designation |
Primary DNB Resident |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room no 25
Cornea and Refractive services Aravind Eye Hospital
Cuddalore main road Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9976893545 |
| Fax |
|
| Email |
poorani.raghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivananda N |
| Designation |
Chief Cornea and Refractive services |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room no 25
Cornea and Refractive services Aravind Eye Hospital
Cuddalore main road Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
7639829012 |
| Fax |
|
| Email |
shivananda.n@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivananda N |
| Designation |
Chief Cornea and Refractive services |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room no 25
Cornea and Refractive services Aravind Eye Hospital
Cuddalore main road Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
7639829012 |
| Fax |
|
| Email |
shivananda.n@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Pondicherry |
| Address |
Aravind Eye Hospital Cuddalore Main road Thavalakuppam Pondicherry |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poorani R |
Aravind Eye Hospital Pondicherry |
Room no 25 Cornea and Refractive services Aravind Eye Hospital Cuddalore main road Thavalakuppam Pondicherry 605007
Pondicherry
PONDICHERRY |
9976893545
poorani.raghu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Aravind Eye Hospital Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Not Applicable |
| Intervention |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients diagnosed with Vernal keratoconjunctivitis
2 Age group includes 5 to 50 years
3 Willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1 Patients with Shield ulcers
2 Patients with severe Dry eye and other ocular surface disorders
3 Patients with Hydrops and Post Hydrops
4 Patients with Cataract
5 Corneal opacity
6 Patients with any other vision threatening retinal pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients with vernal keratoconjunctivitis will have topographical changes suggestive of Early keratoconus |
At baseline (Day 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
11/01/2021 |
| 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
|
Study not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim : To study the topographical corneal changes in patients with Vernal keratoconjunctivitis
Expected outcome: Patients with vernal keratoconjunctivitis will have topographical changes suggestive of Early keratoconus |