| CTRI Number |
CTRI/2025/09/094391 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Diagnostic Performance OF ASOCT AND Gonioscopy For Angle Closure In Hypermertopic Eyes |
|
Scientific Title of Study
|
Accuracy of Anterior Segment Optical Computed tomography versus Gonioscopy for Detecting Angle Closure in Hypermetropes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrASHWINIT |
| Designation |
DNB RESIDENT |
| Affiliation |
IGGGHPGI |
| Address |
Indra Gandhi Govt General Hospital and Post Graduate Institution
PUDUCHERRY
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9489329925 |
| Fax |
|
| Email |
ashwini.tamilarasan20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AROKIAM JOHN BOSCO |
| Designation |
SPECIALISTGRADE1 |
| Affiliation |
Indra Gandhi Govt General Hospital Post Graduate Institution |
| Address |
Indra Gandhi Govt General Hospital and Post Graduate Institution
PUDUCHERRY
Pondicherry
PONDICHERRY
605001
India |
| Phone |
8903727097 |
| Fax |
|
| Email |
arokiamjohnbosco@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrASHWINIT |
| Designation |
DNB RESIDENT |
| Affiliation |
IGGGHPGI |
| Address |
Indra Gandhi Govt General Hospital and Post Graduate Institution
PUDUCHERRY
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9489329925 |
| Fax |
|
| Email |
ashwini.tamilarasan20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indra Gandhi Govt General Hospital and Post Graduate Institution Pondicherry-605001
|
|
|
Primary Sponsor
|
| Name |
Indra Gandhi Govt General Hospital and Post Graduate Institution |
| Address |
VICTOR SIMONEL ST
PONDICHERRY 605001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAROKIAM JHON BOSCO |
Indra Gandhi Govt General hospital Post Graduate Institution |
VICTOR SIMON STREET
PONDICHERRY
Pondicherry
PONDICHERRY |
8903727097
arokiamjohnbosco@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GHIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
WITH HYPERMETRPIC EYES TO DETECT ANGLE CLOSURE
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 50 years and above
Patients with hypermetropia
Patients with short axial length and normal axial length
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with myopia
Patient with history of intraocular surgery penetrating trauma in the eye previous anterior segment laser treatment corneal disorders such as corneal endothelial dystrophy corneal opacity
Patient with an aphakic or pseudophakic eye
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the sensitivity and specificity of AOD 750,ACA and ARA in detecting angle closure compared to gonioscopy |
at baseline 4 weeks 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether AOD 750 or ACA is a predictor for detecting of angle closure in hypermetropic patients with normal & short axial length when compared to gonioscopy |
baseline 4weeks 8weeks |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
18/09/2025 |
| 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="5"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
TO ASSESS THE SENSITIVITY AND SPECIFICITY OF ASOCT IN DETECTING ANGLE CLOSURE WHEN COMPARED TO GONIOSCOPY IN HYPERMETROPIC PATIENTS WITH NORMAL AND SHORT AXIAL LENGTH TO ASSESS WHETHER AOD 750 OR ACA IS APREDICTOR FOR DETECTING OF ANGLE CLOSURE IN HYPERMETROPIC PATIENTS WITH NORMAL AND SHORT AXIAL LENGTH WHEN COMPARED TO GONIOSCOPY TO ASSESS THE SENSITIVITY AND SPECIFICITY OF AOD 750,ACA AND ARA IN DETECTING ANGLE CLOSURE COMPARED TO GONIOSCOPY |