| CTRI Number |
CTRI/2020/11/028912 [Registered on: 05/11/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Optic Disc Perfusion in Glaucoma using OCT Angiography. |
|
Scientific Title of Study
|
Optic Disc Perfusion in Glaucoma Suspect and Primary Open Angle Glaucoma using Optical Coherence Tomography Angiography. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SECIEC00119 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananya Dutta |
| Designation |
Post Diploma DNB resident |
| Affiliation |
Shri Kanchi Kamakoti Medical Trust Hospital,Sankara Eye Hospital |
| Address |
room no.18, Glaucoma clinic, Shri Kanchi Kamakoti Medical Trust Hospital,Sankara Eye Hospital, Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India
room no.18, Glaucoma clinic Sankara Eye Hospital, Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9401902372 |
| Fax |
|
| Email |
anyadutta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Rajesh Prabu |
| Designation |
consultant, Dept of Pediatric Ophthalmology and Strabismus |
| Affiliation |
Shri Kanchi Kamakoti Medical Trust Hospital,Sankara Eye Hospital |
| Address |
Shri Kanchi Kamakoti Medical Trust Hospital,Sankara Eye Hospital, Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India
Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9442522373 |
| Fax |
|
| Email |
drrajeshprabu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Dutta |
| Designation |
Post Diploma DNB resident |
| Affiliation |
Shri Kanchi Kamakoti Medical Trust Hospital,Sankara Eye Hospital |
| Address |
room no.18, Glaucoma clinic,Shri Kanchi Kamakoti Medical Trust Hospital,Sankara Eye Hospital, Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India
room no.13 Central OPD, Sankara Eye Hospital, Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9401902372 |
| Fax |
|
| Email |
anyadutta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Kanchi Kamakoti Medical Trust Hospital, Sankara Eye Hospital,Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Shri Kanchi Kamakoti Medical Trust Hospital Sankara Eye Hospital |
| Address |
Sathy Rd, Sivanandhapuram, Coimbatore, Tamil Nadu, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ananya Dutta |
Shri Kanchi Kamakoti Medical Trust Hospital, Sankara Eye Hospital |
room no. 18, Glaucoma clinic, Sankara eye hospital,Sathy Rd, Sivanandhapuram.
Coimbatore
TAMIL NADU |
9401902372
anyadutta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Age greater than 18 years.
2 Open iridocorneal angle on gonioscopy
3 Best corrected visual acuity of minimum 0.48 logMAR units or more.
|
|
| ExclusionCriteria |
| Details |
1 History of intra ocular surgery except glaucoma surgery and uncomplicated cataract surgery.
2 Secondary causes of glaucoma
3 Non glaucomatous optic neuropathies
4 Vascular or non-vascular retinopathies
• Other ocular or systemic diseases that may affect vision.
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
To evaluate optic disc perfusion using Optical Coherence Tomography- Angiography in eyes with Primary Open Angle Glaucoma (POAG) and Glaucoma Suspects.
|
on the day of enrollment into the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate association between vessel density measurements using OCT-Angiography and RNFL Analysis using SD-OCT in Primary Open Angle Glaucoma and Glaucoma suspect.2.To establish normative data for optic disc perfusion using OCT-Angiography. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2020 |
| Date of Study Completion (India) |
31/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Glaucoma is considered as one of the leading causes of irreversible blindness in the world. Optic nerve head (ONH) perfusion may be associated with development of glaucoma. A reliable and reproducible clinical method for evaluating the optic nerve head perfusion will thus help us in early detection and monitoring of glaucoma. Optical Coherence Tomography Angiography is a new method of analysis based on high resolution, non-invasive imaging technique whereby retinal, choroidal and optic nerve head circulation can be visualised without the need to inject any contrast agent. The purpose of this study is to assess whether OCT Angiography is a reliable clinical method for evaluating the optic nerve head perfusion in Glaucoma suspect and Primary Open Angle Glaucoma(POAG) by comparing with healthy eyes and to correlate the functional vasculature parameters obtained from OCTA to the structural parameters obtained from Spectral–domain(SD) OCT RNFL thickness measurements. |