| CTRI Number |
CTRI/2021/05/033583 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
19/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of angle using two machines (ASOCT and UBM) in shallow angle glaucoma following peripheral iris hole. |
|
Scientific Title of Study
|
To Evaluate The Anterior Segment Morphological Parameters By Using Anterior Segment Optical Coherence Tomography (ASOCT) And Ultrasound Biomicroscopy (UBM) In Patients With Shallow Angle Of Anterior Chamber. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NITIKA BERI |
| Designation |
Senior Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Room Number 510, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital, Dilshad Garden
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
berinitika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NITIKA BERI |
| Designation |
Senior Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Room Number 510, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital, Dilshad Garden
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
berinitika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NITIKA BERI |
| Designation |
Senior Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Room Number 510, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital, Dilshad Garden
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
berinitika@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF OPHTHALMOLOGY, UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL, DILSHAD GARDEN, DELHI, 110095 |
|
|
Primary Sponsor
|
| Name |
NITIKA BERI |
| Address |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL, TAHIRPUR ROAD, DILSHAD GARDEN, DELHI-110095 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NITIKA BERI |
UCMS AND GTB HOSPITAL |
ROOM NUMBER 510, DEPARTMENT OF OPHTHALMOLOGY, UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL, TAHIRPUR ROAD, DILSHAD GARDEN, DELHI-110095
East
DELHI |
9871130760
berinitika@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GURU TEG BAHADUR ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H400||Glaucoma suspect, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of primary angle closure glaucoma |
|
| ExclusionCriteria |
| Details |
Any intraocular or refractive surgery, active uveitis, corneal opacity/diseases which would hinder the visualization of parameters of the eye, pregnant and lactating females. |
|
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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 |
On UBM :
Angle opening distance (AOD) at 500µm and 750µm
Angle Recess area (ARA) at 500µm and 750µm
Trabecular iris angle (TIA) at 500µm and 750µm
On ASOCT:
Angle opening distance (AOD) at 500µm and 750µm
Anterior chamber angle (ACA) at 500µm and 750µm
Trabecular iris space area (TISA) at 500 µm and 750 µm |
2 weeks, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in central corneal thickness post Peripheral iridotomy.
Change in endothelial density post peripheral iridotomy |
2 weeks, 3 months and 6 months |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/05/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
STUDY TITLE: To evaluate the anterior segment morphological parameters by using anterior segment optical coherence tomography (ASOCT) and ultrasound biomicroscopy (UBM) in patients with shallow angle of anterior chamber. Aim: To evaluate the anterior segment morphological changes in the angle by using ASOCT and UBM in patients with shallow angle.
SETTING: Department of Ophthalmology, University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi-110095. Sample size: A total of 40 patients will be enrolled. Methods: All patients of primary angle closure glaucoma requiring laser peripheral iridotomy will be included. All patients will be assessed prior and after laser peripheral iridotomy on both the machines that is ASOCT and UBM (both are non invasive and OPD procedures). The change in various parameters will be assessed. Conflict of Interest : None Financial Disclosures : None Budget details : None
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