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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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