| CTRI Number |
CTRI/2019/11/021846 [Registered on: 01/11/2019] Trial Registered Prospectively |
| Last Modified On: |
01/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study On The Profile And Vision Related Quality Of Life In Ocular And Orbital Injuries Due To Blunt Trauma In A Tertiary Care Centre |
|
Scientific Title of Study
|
Observational Study On Epidemiological Profile And Vision Related Quality Of Life In Ocular And Orbital Injuries Due To Blunt Trauma In A Tertiary Care Centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha Nair |
| Designation |
Primary DNB |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No: 13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9400539300 |
| Fax |
|
| Email |
megnair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Jayagayathri |
| Designation |
Cheif, Orbit Clinic |
| Affiliation |
Aravind Eye Hospial |
| Address |
Room No:13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9843942425 |
| Fax |
|
| Email |
jayagayathri.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Nair |
| Designation |
Primary DNB |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No:13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9400539300 |
| Fax |
|
| Email |
megnair@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Megha Nair |
| Address |
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry PIN:605007 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Megha Nair |
Aravind Eye Hospital |
Room No:13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry PIN:605007
Pondicherry
PONDICHERRY |
9400539300
megnair@gmail.com |
|
|
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: S05||Injury of eye and orbit, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
No Comparator |
No Comparator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients among 18-70 years of age visiting Aravind Eye Hospital, Pondicherry at the outpatient department of General clinic and Casualty with blunt trauma within 1 month of occurrence over a period of 1 year.
|
|
| ExclusionCriteria |
| Details |
1. Those patients suffering from severe head injuries that require immediate referral to higher centres.
2. Patients with penetrating trauma to eye.
3. Mentally retarded patients and those who cannot understand and reciprocate the questionnaire on vision related quality of life.
4. Patients who are not oriented in time, place and person.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. This study will provide an epidemiological and clinical profile of ocular and orbital injuries due to blunt trauma among ages 18-70 years at Aravind Eye Hospital, Pondicherry.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to study whether blunt trauma causes poor vision related quality of life.
2.To study factors that delay in seeking treatment.
3.To study the severity of blunt trauma among patients using protective gadgets and those who not. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
01/11/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study to determine the epidemiological profile of ocular and orbital injuries due to blunt trauma among age groups of 18-70 years and the impact of blunt trauma on the vision related quality of life within one month of follow up. The vision related quality of life is determined by a questionnaire ( IND-VFQ33) , checking the psycho-social impact and visual symptoms scale. |