| CTRI Number |
CTRI/2026/03/106352 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Artificial Intelligence–Based Analysis of the optic nerve in sinus CT scans |
|
Scientific Title of Study
|
Revamping Delano’s classification of optic nerve variants using AI powered grading |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaypradha S |
| Designation |
Doctor, Post-Graduate Resident |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Radio-Diagnosis,
Saveetha Medical College
and Hospital, SIMATS, Chennai.
Chennai TAMIL NADU 602105 India |
| Phone |
08754537265 |
| Fax |
|
| Email |
jaypradha24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Muthiah P |
| Designation |
Doctor, Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Radio-Diagnosis,
Saveetha Medical College
and Hospital, SIMATS, Chennai.
Chennai TAMIL NADU 602105 India |
| Phone |
9843175404 |
| Fax |
|
| Email |
drmuthiahmd@gmail.co m |
|
Details of Contact Person Public Query
|
| Name |
Jaypradha S |
| Designation |
Doctor, Post-Graduate Resident |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Radio-Diagnosis,
Saveetha Medical College
and Hospital, SIMATS, Chennai.
Chennai TAMIL NADU 602105 India |
| Phone |
08754537265 |
| Fax |
|
| Email |
jaypradha24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil |
| Saveetha Institute of Medical and Technical sciences |
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Radio-Diagnosis,
Saveetha Medical College and Hospital, SIMATS, Chennai -
602105 |
| Type of Sponsor |
Private medical college |
|
|
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 Jaypradha S |
Saveetha Medical College and Hospital |
Department of Radio-Diagnosis,Saveetha Medical College and Hospital, SIMATS,
Chennai - 602105 Chennai TAMIL NADU |
08754537265
jaypradha24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (greater than or equal to 18 years) undergoing CT scan of paranasal sinuses. Patients evaluated for sinonasal symptoms or diseases. CT PNS scans with adequate visualization of sphenoid sinus, posterior ethmoid sinus, and optic nerve canal. CT images of adequate diagnostic quality for assessment of optic nerve course. |
|
| ExclusionCriteria |
| Details |
Patients with prior sinonasal surgery. History of craniofacial trauma affecting paranasal sinuses. Congenital craniofacial anomalies involving the sinonasal region. Poor quality CT PNS images with artefacts. CT scans with inadequate visualization of optic nerve canal or sphenoid sinus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of the AI-based application in classifying optic nerve course according to Delano classification on CT PNS compared with radiologist assessment as the reference standard. |
Outcomes will be assessed at the time of CT scan interpretation during the study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Distribution of Delano types (Type 1–4) of optic nerve on CT PNS.
|
Outcomes will be assessed at the time of CT scan interpretation during the study period. |
Prevalence of associated anatomical variations such as optic nerve dehiscence, Onodi cell, & pneumatized anterior clinoid process.
|
Outcomes will be assessed at the time of CT scan interpretation during the study period. |
| Agreement between AI-based classification & radiologist assessment of optic nerve course. |
Outcomes will be assessed at the time of CT scan interpretation during the study period. |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
31/03/2026 |
| 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)
|
Completed |
| 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 evaluate the diagnostic accuracy of an artificial intelligence based application in classifying the course of the optic nerve according to Delano classification on computed tomography imaging of paranasal sinuses. Identification of optic nerve course is important before functional endoscopic sinus surgery because certain anatomical variations increase the risk of surgical injury and permanent visual loss. This observational cross sectional study will be conducted in the Department of Radiodiagnosis at Saveetha Medical College and Hospital Chennai among adult patients undergoing CT scan of paranasal sinuses. A total of 500 CT scans will be included. Each CT scan will be reviewed by experienced radiologists and classified according to Delano classification which will serve as the reference standard. The same CT images will be analyzed using an artificial intelligence based mobile application which uses convolutional neural network technology for automated classification of optic nerve variants. The diagnostic performance of the artificial intelligence application will be assessed by calculating sensitivity specificity positive predictive value negative predictive value and area under receiver operating characteristic curve. The agreement between artificial intelligence based classification and radiologist interpretation will be evaluated. The study will also assess the distribution of Delano types and associated anatomical variations such as optic nerve dehiscence Onodi cell and pneumatized anterior clinoid process on CT imaging. The results of this study may help in improving preoperative radiological assessment and surgical planning in patients undergoing endoscopic sinus surgery. |