| CTRI Number |
CTRI/2024/05/066887 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Influence of artery flow on different stages of glaucoma |
|
Scientific Title of Study
|
A study of ophthalmic artery flow dynamics across the clinical stages of primary open angle glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash V Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
MS Ramaiah University of Applied Sciences |
| Address |
Department of Allied Health Sciences, Faculty of Life & Allied Health Sciences, MS Ramaiah University of Applied Sciences
Bangalore
KARNATAKA
560054
India |
| Phone |
9964014884 |
| Fax |
|
| Email |
avinash.prabhu10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avinash V Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
MS Ramaiah University of Applied Sciences |
| Address |
Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, MS Ramaiah University of Applied Sciences
KARNATAKA
560054
India |
| Phone |
9964014884 |
| Fax |
|
| Email |
avinash.prabhu10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avinash V Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
MS Ramaiah University of Applied Sciences |
| Address |
Department of Allied Health Sciences, Faculty of Life & Allied Health Sciences, MS Ramaiah University of Applied Sciences
Bangalore
KARNATAKA
560054
India |
| Phone |
9964014884 |
| Fax |
|
| Email |
avinash.prabhu10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical Hospital, Ramaiah Teaching Hospital |
|
|
Primary Sponsor
|
| Name |
Avinash V Prabhu |
| Address |
Department of Allied Health Sciences, Faculty of Life & Allied Health Sciences, MS Ramaiah University of Applied Sciences |
| 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 Pradeep R |
Ramaiah Medical Hospital |
Department of Neurology, 1st floor, Room no-3
Bangalore
KARNATAKA |
9964014884
avinash.prabhu10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College_Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects to be over 18 years of age
Best corrected visual acuity 0.5 (6/19 Snellen fraction) or more in each eye
No history of ocular trauma and/or surgery and/or inflammation within the last 6 months
|
|
| ExclusionCriteria |
| Details |
o Ocular hypertension
o Glaucoma other than POAG
o Cataract
o Diabetic retinopathy
o Chronic retinal diseases
o Any significant cardiac or pulmonary condition
o Stenosis of the carotid arteries equal to and greater than 50%
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pusatility index, mean arterial peak velocity, resistivity index, mean flow velocity, diastolic flow velocity, ocular perfusion pressure |
Pusatility index - baseline, mean arterial peak velocity - baseline, resistivity index - baseline, mean flow velocity - baseline, diastolic flow velocity - baseline, ocular perfusion pressure - baseline. All the data are collected simultaneously only once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perimetry, Ocular Coherence Tomography, Intra-Ocular Pressure, Vision |
Perimetry - baseline, Ocular Coherence Tomography - baseline, Intra-Ocular Pressure - baseline, Vision -baseline across the 4 groups. All the data are collected simultaneously, only once |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
15/05/2024 |
| 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="3"
Months="8"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study
aims to detect glaucoma staging through ophthalmic artery flow
examination. This could lead to a unique way of identifying the disease, leading to the modification in the existing screening cost (lowering) and chair time protocols. Research area targeting the circulatory aspects of optic disc and glaucoma can be further evolved, both at the functional and cellular level. Newer testing algorithms can be developed and experimented as next phase of research to long sustain |