| CTRI Number |
CTRI/2022/04/041654 [Registered on: 05/04/2022] Trial Registered Prospectively |
| Last Modified On: |
06/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate macular and peripapillary microvascular changes in systemic hypertension as measured by optical coherence tomography angiography technology |
|
Scientific Title of Study
|
Evaluation of macular and peripapillary microvascular changes in systemic hypertension as measured by optical coherence tomography angiography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashi Gupta |
| Designation |
Post graduate trainee |
| Affiliation |
Maulana Azad Medical college and Associated Guru Nanak Eye Centre, New Delhi |
| Address |
Room No. 221,Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja ranjit singh marg, New Delhi- 110002
New Delhi
DELHI
110002
India |
| Phone |
9873976836 |
| Fax |
|
| Email |
yaasshi12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Thakar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical college and Associated Guru Nanak Eye Centre, New Delhi |
| Address |
Room No. 221,Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja ranjit singh marg, New Delhi- 110002
New Delhi
DELHI
110002
India |
| Phone |
9873976836 |
| Fax |
|
| Email |
meenakshithakar147@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashi Gupta |
| Designation |
Post graduate trainee |
| Affiliation |
Maulana Azad Medical college and Associated Guru Nanak Eye Centre, New Delhi |
| Address |
Room No. 221,Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja ranjit singh marg, New Delhi- 110002
New Delhi
DELHI
110002
India |
| Phone |
9873976836 |
| Fax |
|
| Email |
yaasshi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College And Associated Guru Nanak Eye Centre, New Delhi 110002 |
|
Primary Sponsor
Modification(s)
|
| Name |
Department of Ophthalmology |
| Address |
Room No. 221,Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja ranjit singh marg, New Delhi- 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Yashi Gupta |
Guru Nanak Eye Centre |
Room No. 221,Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja ranjit singh marg, New Delhi- 110002
New Delhi
DELHI |
9873976836
yaasshi12@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: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Hypertensive patients on medication for more than 5 years
2.Age: 30-60 years
3.BCVA ≥ 6/12
|
|
| ExclusionCriteria |
| Details |
1.Significant ocular media opacity (in order to maximize good quality images)
2.Grade 3 hypertensive retinopathy and above (according to Keith Wagener Barker classification).
3.Any other ocular pathology, e.g. macular edema, diabetic retinopathy, optic nerve disorders etc.
4.Any intraocular surgery
5.Any other systemic illness.
6.Refractive errors (> +3 D, axial length (AL) >26.0 mm)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1-To measure Macular and peripapillary OCTA parameters (VD, PD and FAZ dimensions) in systemic hypertension vs control group. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Measurement of structural OCT Parameters (CMT, GC-IPL and RNFL thicknesses)
in systemic hypertension vs normal control group.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/04/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims at evaluating changes occurring in the microvasculature of the retina primarily evaluated at the macular and peripapillary region through oct angiography in hypertensive patients in comparison to the normal control group. The study aims at picking up subtle signs of microvascular damage as measured by oct and octa technology well before clinical signs of hypertension manifest in the body. |