FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074124 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 18/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Validation of a portable fundus camera 
Scientific Title of Study   Validation of A Portable Fundus Camera Using Upcycled Smartphone as Compared to the Routine Dilated Fundus Evaluation by the Clinicians for Assessing Posterior Segment Diseases  
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Usha Tejaswini S 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital 
Address  Room No 21, First floor, Glaucoma Clinic, B- Block, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam

Pondicherry
PONDICHERRY
605007
India 
Phone  09916808738  
Fax  0413-2618848  
Email  ushatejaswini.s@aravind.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Tejaswini S 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital 
Address  Room No 21, First floor, Glaucoma Clinic, B- Block, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam


PONDICHERRY
605007
India 
Phone  09916808738  
Fax  0413-2618848  
Email  ushatejaswini.s@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr Usha Tejaswini S 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital 
Address  Room No 21, First floor, Glaucoma Clinic, B- Block, Aravind Eye Hospital, Cuddalore main road, Thavalakuppam


PONDICHERRY
605007
India 
Phone  09916808738  
Fax  0413-2618848  
Email  ushatejaswini.s@aravind.org  
 
Source of Monetary or Material Support  
Laboratory for Sustainable Development LABSD 7F C Tower Samsung Electronics Seoul RD Campus 33 Seongchon gil Seocho gu Seoul Republic of Korea  
 
Primary Sponsor  
Name  LabSD Inc 
Address  7F, C Tower, Samsung Electronics Seoul R&D Campus, 33, Seongchon-gil, Seocho-gu, Seoul, Republic of Korea 
Type of Sponsor  Other [Device 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 Usha Tejaswini  Aravind Eye Hospital  Room NO. 21 22 120 A BLOCK Cuddalore main road Thavalakuppam Pondicherry
Pondicherry
PONDICHERRY 		 09916808738
0413-2618848
ushatejaswini.s@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Aravind Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria for cases
Patients with posterior segment pathology who are willing to give informed written consent and fulfil the criteria mentioned below
1. Patient of age ≥18 years and ≤ 70 years
2. Clear media to facilitate capturing of fundus image, either phakic or pseudophakic
3.Patients who have completed evaluation by respective speciality clinician

Inclusion criteria for controls
Patients without posterior segment pathology who are willing to give informed written consent and fulfil the criteria mentioned below:
1. Patient of age ≥18 years and ≤ 70 years
2. Clear media to facilitate capturing of fundus image, either phakic or pseudophakic
3. Patients who have completed evaluation by comprehensive clinician



 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To validate the portable fundus camera using upcycled smartphone (EYELIKEâ„¢ digital ophthalmoscope) in diagnosing posterior segment diseases as compared to gold standard dilated fundus examination by the clinicians with indirect ophthalmoscopy.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
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)   10/10/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  


Globally 1.1 billion people suffer visual impairment.1 The causes earlier were more infectious diseases like trachoma and onchocerciasis.2 But in the recent days due to increase in life expectancy, and widespread adoption of western diets/lifestyles non-communicable disease are on rise. Consequently, posterior segment diseases (PSD) such as diabetic retinopathy (DR), glaucoma, and age-related macular degeneration play a major role in causing visual impairment.2

From 1990 to 2015 visual impairment due to DR has nearly doubled from 1.4 million to 2.6 million and glaucoma has increased from 3.0 million to 4.0 million. This rising global burden of eye diseases is increasing both health and financial challenges for patients and the healthcare system.2 Approximately 47% of the population in developing countries are still living in rural or resource-limited areas where trained ophthalmologists are not available readily.3

Posterior segment screening is crucial for early diagnosis and treatment of PSD.4 Advances in technology and optics have led to the widespread use of fundus cameras, especially for screening in peripheral outreach services. There are a lot of fundus cameras in the market but are quite costly and not always affordable.

Along with this another modern era problem is electronic waste. LabSD (Inc., 7F, C Tower, Samsung Electronics Seoul R&D Campus, 33, Seongchon-gil, Seocho-gu, Seoul, Republic of Korea) and Samsung (have successfully combined these problems and made a product, EYELIKEâ„¢ digital ophthalmoscope, out of recycled polycarbonate materials and repurposed Samsung phones for making fundus camera that is portable and can be easily used by any trained technician.

We expect that this innovative fundus camera using upcycled smartphone will be helpful in strengthening the screening process and early detection, and referral of patients with posterior segment pathologies. If the device proves good in terms of sensitivity and specificity, in future it can be employed in capturing PSD in remote eye care settings such as vision centers and outreach camps.


 
Close