FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090725 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening 
Study Design  Other 
Public Title of Study   A Study Comparing a New Widefield Fundus Camera with a Standard Camera for Detecting Retinal Conditions in Patients at an Eye Clinic. 
Scientific Title of Study   Comparison of the Pristine 5.0 Widefield Fundus Camera with a Reference Standard Fundus Camera in a Retina Clinic  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jay Sheth  
Designation  Faculty, Vitreoretina and Uveitis Services 
Affiliation  Shantilal Shanghvi Eye Institute 
Address  Vitreoretina and Uveitis Services Department Shantilal Shanghvi Eye Institute RJ Gaikwad road Barkat Ali Naka Wadala East Mumbai

Mumbai
MAHARASHTRA
400037
India 
Phone  9961167200  
Fax    
Email  Jay.Sheth@ssei.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shonraj B G 
Designation  Head-Clinical Research 
Affiliation  Remidio Innovative Solution Pvt Ltd, Bengaluru, India 
Address  Clinical Research Department, Remidio Innovative Solutions Private Limited Vacuum Techniques Compound, 1St Cross Road, Peenya Industrial Area, Phase-I, Phase -1, Peenya, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone  8886738267  
Fax    
Email  shonraj.b@remidio.com  
 
Details of Contact Person
Public Query  
Name  Ranjitha K 
Designation  Associate Optometrist 
Affiliation  Remidio Innovative Solution Pvt Ltd, Bengaluru, India 
Address  Clinical Research Department, Remidio Innovative Solutions Private Limited, Vacuum Techniques Compound, 1St Cross Road, Peenya Industrial Area, Phase-I, Phase -1, Peenya, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone  9113964481  
Fax    
Email  Ranjitha.k@remidio.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Remidio Innovative Solutions Pvt Ltd 
Address  Remidio Innovative Solutions Private Limited No, 1-51-2/12, Ii Floor, Vacuum Techniques Compound, 1St Cross Road, Peenya Industrial Area, Phase-I, Phase -1, Peenya, Bengaluru, Karnataka 560058 
Type of Sponsor  Other [Medical Equipment Manufacturer] 
 
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 Jay Sheth  Shantilal Shanghvi Eye Institute  Vitreoretina Department, RJ Gaikwad Rd opposite Ganesh Nagar near eastern freeway wadala wast Mumbai Maharastra 400037
Mumbai
MAHARASHTRA 		 09961167200

Jay.Sheth@ssei.ind.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shantilal Shanghvi Foundation Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  New widefield fundus camera  Retinal imaging performed using the new widefield fundus camera (model: Pristine 5.0) 
Comparator Agent  Reference standard fundus camera used in routine clinical practice  To compare image quality, field of view, and clinical utility in retinal evaluation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Every consecutive participant above 18 years of age who consents to participate in the study and visit the retina clinic 
 
ExclusionCriteria 
Details  Subjects with significant media opacity that blocks a sufficient view of the fundus, such as advanced cataracts, corneal opacity, vitreous hemorrhage, or other pathology.

Subjects with inability to fixate on the target, such as those with nystagmus or amblyopia.

Subjects with active eye infection, sudden loss of vision, or who are in the immediate post-operative period (less than two weeks).

Subjects who are hypersensitive to light or unable to tolerate fundus imaging.

Subjects for whom dilation is contraindicated, such as those with angle closure glaucoma or ocular hypertension. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard.  Percentage of agreement between Diabetic Retinopathy (DR) stages detected using Pristine 5.0 and Reference Standard. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of image quality, including factors such as illumination, focus, fixation, and presence of external artifacts, for images captured using Pristine 5.0 and the Reference Standard.  At the time of imaging (baseline visit) 
Sensitivity, specificity, positive predictive value, and negative predictive value of diabetic retinopathy detection by the Pristine 5.0 system compared to the Reference Standard.  At the time of image interpretation (within 1 week of image capture) 
Sensitivity, specificity, positive predictive value, and negative predictive value of diabetic retinopathy diagnosis by the Pristine 5.0 system and the Reference Standard compared to the ophthalmologist diagnosis.  At the time of image interpretation (within 1 week of image capture) 
 
Target Sample Size   Total Sample Size="218"
Sample Size from India="218" 
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)   22/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 is a prospective, randomized, comparative study designed to evaluate the performance of the Pristine 5.0 Widefield Fundus Camera in comparison with a reference standard fundus camera and an ultrawide field camera in a retina clinic setting. The study will assess image quality, retinal lesion detection, and diabetic retinopathy grading based on images captured by both devices. The Pristine 5.0 camera provides high-resolution imaging with automatic focus and capture modes. Eligible participants will undergo dilated fundus photography using both devices. Two masked retina specialists will grade all images for quality and retinal pathology. Patient comfort and experience with Pristine 5.0 will be evaluated using a structured questionnaire. The study aims to determine diagnostic accuracy and agreement levels between imaging systems and clinical evaluation by ophthalmologists. 
Close