| CTRI Number |
CTRI/2019/05/018876 [Registered on: 01/05/2019] Trial Registered Prospectively |
| Last Modified On: |
30/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of relationship between length of eye lens and valvular heart disease |
|
Scientific Title of Study
|
A study of relationship between axial eye length and mitral valve prolapse(MVP) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishnananda Nayak |
| Designation |
BSc CVT,MSc CVT,Phd |
| Affiliation |
School Of Allied Health Science, Manipal Academy Of Higher Education |
| Address |
Department of Cardio Vascular Technology
School Of Allied Health Science,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449215487 |
| Fax |
|
| Email |
krishnayak2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKrishnananda Nayak |
| Designation |
BSc CVT,MSc CVT,Phd |
| Affiliation |
School Of Allied Health Science, Manipal Academy Of Higher Education |
| Address |
Department of Cardio Vascular Technology
School Of Allied Health Science,
Manipal
Department of Cardio Vascular Technology
School Of Allied Health Science,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449215487 |
| Fax |
|
| Email |
krishnayak2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
BSc CVT,MSc CVT,Phd |
| Affiliation |
School Of Allied Health Science, Manipal Academy Of Higher Education |
| Address |
Department of Cardio Vascular Technology
School Of Allied Health Science,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449215487 |
| Fax |
|
| Email |
krishnayak2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and hospital, room no 34, 3rd floor, department of cardilogy |
|
|
Primary Sponsor
|
| Name |
K Prathiksha Prabhu |
| Address |
Department of Cardio Vascular Technology
School Of Allied Health Science,
Manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Megha A |
Department of Cardio Vascular Technology
School Of Allied Health Science,
Manipal |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishnananda Nayak |
Kasturba medical college |
room no 34, 3rd floor, department of cardiology
Udupi
KARNATAKA |
09964015487
krishnayak2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
more axial eye length,mitral valve prolapse |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with mitral valve prolapse and patients with more axial length
|
|
| ExclusionCriteria |
| Details |
Rheumatic heart disease, congenital heart disease, active eye infection |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation between axial length of eye and mitral valve prolapse |
assessment will be done immediatly after the study is performed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mitral valve prolapse at the time of evaluation only |
axial length and mitral regurtitation at the time of evaluation only |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
15/05/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Barlow JB,Bosman CK: Am Heart jornal 1966 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective single center study,which correlates axial eye length and mitral valve prolapse. Spontaneously during some examination it is found that, Those having mitral valve prolapse also showed increased axial length. When we search in literature no such association was studied to focus on outcomes of such population and early diagnosis or treatment part may help in preventing later complications. Hence the study is planned. |