| CTRI Number |
CTRI/2024/02/063211 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Imaging called OCTA examines the fovea, the central retina with ideally no blood vessels. Comparing the foveal avascular zone in glaucoma to healthy eyes reveals blood vessel pattern changes, aiding in glaucoma diagnosis and management by understanding its impact on ocular blood vessels.
|
|
Scientific Title of Study
|
Foveal avascular zone analysis in glaucoma spectrum vs healthy eyes with optical coherence tomography angiography. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEC/CHN/EC/DODNB/20/2023 VERSION 1.0 DATED 21.12.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
katheeja banu |
| Designation |
secondary DNB resident |
| Affiliation |
Aravind eye hospital |
| Address |
aravind eye hospital,opposite to saveetha dental hospital,poonamalle high road,noombal,chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9787611123 |
| Fax |
|
| Email |
katheejakamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drneethu mohan |
| Designation |
HOD,glaucoma services |
| Affiliation |
Aravind eye hospital |
| Address |
aravind eye hospital,opposite to saveetha dental hospital,poonamalle high road,noombal,chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9894705666 |
| Fax |
|
| Email |
neethumohan@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
DRMBMadhuri |
| Designation |
senior medical consultant |
| Affiliation |
Aravind eye hospital |
| Address |
aravind eye hospital,opposite to saveetha dental hospital,poonamalle high road,noombal,chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9566440567 |
| Fax |
|
| Email |
madhuri.r@aravind.org |
|
|
Source of Monetary or Material Support
|
| ARAVIND EYE HOSPITAL,OPPOSITE TO SAVEETHA DENTAL COLLEGE AND HOSPITAL,POONAMALLE HIGH ROAD,NOOMBAL,CHENNAI 600077 |
|
|
Primary Sponsor
|
| Name |
Dr K Katheeja Banu |
| Address |
ARAVIND EYE HOSPITAL,OPPOSITE TO SAVEETHA DENTAL COLLEGE AND HOSPITAL,POONAMALLE HIGH ROAD,NOOMBAL,CHENNAI 600077. |
| 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 |
| DrKKATHEEJA BANU |
ARAVIND EYE HOSPITAL |
ARAVIND EYE HOSPITAL,OPPOSITE TO SAVEETHA DENTAL COLLEGE AND HOSPITAL,POONAMALLE HIGH ROAD,NOOMBAL,CHENNAI 600077
Chennai
TAMIL NADU |
9787611123
katheejakamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ARAVIND EYE HOSPITAL CHENNAI IEC-AEH CHN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
clear media primary open angle glaucoma ocular hypertension,glaucoma suspects BCVA MORE THAN 6 12 |
|
| ExclusionCriteria |
| Details |
myopia more than 6D
Coexisting retinopathy
Secondary glaucoma
Angle closure glaucoma
Media opacities
Corneal abnormalities
Any previous ocular surgery except uncomplicated cataract and
glaucoma surgery.
Pregnancy and breastfeeding
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Quantitative evaluation of microcirculation in the foveal avascular zone in POAG patients,Glaucoma suspects, OHT and healthy eyes.
|
at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analyse & compare the obtained data with the data from healthy individuals & correlate the FAZ vessel density changes with the glaucomatous VF changes.
|
at baseline |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/03/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
OCTA (optical coherence tomography angiography) is a quick,
safe ,noninvasive mode of monitoring the glaucoma progression by the assessment
of superficial vessel and perfusion density in the foveal avascular zone. The
patients will be divided into 2 group after undergoing
all baseline investigations are categorized as POAG (if there is increased
Intraocular pressure, disc changes and visual field changes). Glaucoma suspects
(if there is Disc changes, increased/Normal IOP, normal visual fields). Ocular
hypertension (if there is increased IOP, Normal disc, Normal visual fields)
Healthy eyes (if there is Normal IOP,Normal disc
and visual fields). Study group comprising of POAG (primary
open angle glaucoma), OHT(ocular hypertension),Glaucoma suspects and the
control group has healthy eyes. comparing the study group with the control
group will help in quantifying the vascular changes and for early detection and
monitoring the progression or treatment. |