| CTRI Number |
CTRI/2024/04/065261 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The relationship between the eye length and the heart problems |
|
Scientific Title of Study
|
Association of axial length of the eye and mitral valve parameters assessed by echocardiography |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogish Subraya Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Ophthalmology, Kasturba Medical College , Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845308436 |
| Fax |
|
| Email |
yogish.kamath@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogish Subraya Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Ophthalmology, Kasturba Medical College , Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845308436 |
| Fax |
|
| Email |
yogish.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogish Subraya Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Ophthalmology, Kasturba Medical College , Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845308436 |
| Fax |
|
| Email |
yogish.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Opthalmology Kasturba Medical College Manipal Academy of Higher Education
Department of Cardiology Kasturba Medical College Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education |
| Address |
Kasturba Medical College and Hospital Tiger Circle Road Madhava Nagar Manipal Udupi Karnataka PIN-576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yogish Subraya Kamath |
Kasturba Medical Hospital |
Kasturba Medical College and Hospital ,
Department of Opthalmology second floor Room Number 25, Department of Cardiology third floor Room number 34
Udupi
KARNATAKA |
9845308436
yogish.kamath@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Male /female patients of age from 18 to 50 years who have their axial length measured using IOL and willing to participate in the study are
Case group patients visiting ophthalmology OPD with increased axial length of the eye
Control group Age and sex matched group with normal axial length of the eye who are visiting ophthalmology department and willing to join for the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria Patient with severe eye disease patient who have undergone a major eye surgery
Patient with active eye infection
patient with the history of Rheumatic heart disease Ischemic heart disease
patients with Marfan syndrome
patients in whom the axial length of the eye cannot be measured due |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between the axial length of the eye and mitral valve parameters such as mitral valve thickness , coaptation distance , Mitral valve length , severity of Mitral Valve Prolapse and Mitral Regurgitation |
baseline study only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity assessment of regurgitation |
baseline study only |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
20/04/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| 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
|
The
patients who are visiting ophthalmology OPD and willing to participate in the
study who have already undergone axial length and anterior chamber depth
measured by IOL master are taken into the study after explaining all the
details and obtaining their consent for the same.
Case
group involves patients with increased axial length of the eye and control
group involve age and gender matched individuals with normal axial length of
the eye
Patients
with history of major eye surgery active eye infection Marfan syndrome Ischemic heart disease Rheumatic heart disease unable to measure axial
length are all excluded for this study
Participants
of both the case and control group are taken to ECHO OPD their ECG and
echocardiography tests are done They are not charged for Echocardiography and
ECG tests
The
echocardiography data is saved for the offline analysis .
The report of the ECHO
scan would be given to the patient if they would want one , but the patient is
not charged for the same .
The patient would be
advised to consult the Cardiologist if any significant changes are found in the
echocardiography .
This
is to find the association between axial length of the eye and mitral valve
parameters
|