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CTRI Number  CTRI/2025/11/097850 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to check how well the Bio-M Pathfinder rapid test identifies eye diseases in patients 
Scientific Title of Study   Evaluation of the Clinical Performance of In-Vitro Diagnostic System, Bio-M Pathfinder-a Fully Automated Cartridge-Based System, Designed for Rapid, Point-of-Care Biomarker Analysis for Ocular Disease Diagnosis 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Thirumalesh MB 
Designation  Consultant 
Affiliation  Narayana Nethralaya 
Address  121 C Chord Road 1st R Block Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone  9845928933  
Fax    
Email  thirumaleshmb@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Thirumalesh MB 
Designation  Consultant 
Affiliation  Narayana Nethralaya 
Address  121 C Chord Road 1st R Block Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone  9845928933  
Fax    
Email  thirumaleshmb@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Thirumalesh MB 
Designation  Consultant 
Affiliation  Narayana Nethralaya 
Address  121 C Chord Road 1st R Block Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone  9845928933  
Fax    
Email  thirumaleshmb@gmail.com   
 
Source of Monetary or Material Support  
NovoMol-Dx Private Limited NO. 121/C, CHORD ROAD, RAJAJI NAGAR R BLOCK, Bangalore, Karnataka, India 560010 
 
Primary Sponsor  
Name  NovoMol-Dx Private Limited 
Address  121 C Chord Road 1st R Block, Rajajinagar, Bengaluru-560010 Karnataka India. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Sharma  All India Institute of Medical Sciences  Department of Ophthalmology, R.P Centre, AIIMS, New Delhi
New Delhi
DELHI 		 9810856988

namrata.sharma@gmail.com 
Dr Charuta Mandke  H.B.T Medical college and Dr. R.N Cooper Municipal Hospital  Department of Ophthalmology H.B.T Medical college and Dr. R.N Cooper Municipal Hospital
Mumbai
MAHARASHTRA 		 9821029989

charutanm@gmail.com  
Dr K Ramesh Babu  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Department of Ophthalmology Jawaharlal Postgraduate Medical Education and Research (JIPMER), Pondicherry
Pondicherry
PONDICHERRY 		 9787738787

drkrameshbabu@gmail.com 
Dr Swati Devanhalli  M and J Institute of Ophthalmology  Department of Ophthalmology, Sahid Haribhai Rd, Limdi char Rasta, Jahangirpura, Asarwa
Ahmadabad
GUJARAT 		 9375212110

swatiravani65@yahoo.com 
Dr Thirumalesh MB  Narayana Nethralaya  Department of Ophthalmology #121/C Chord Road, 1st ‘R’ Block, Rajaji Nagar, Bangalore
Bangalore
KARNATAKA 		 09845928933

thirumaleshmb@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Approved 
Institute Ethics Committee, B.J. Medical College & Civil Hospital, Ahmedabad  Approved 
Institute Ethics Committee, Mumbai H. B. T. Medical College And Dr. R.N. Cooper Municipal Hospital  Approved 
Institutional Ethics Committee Jawaharlal Institute of Postgraduate Medical Education and Research  Submittted/Under Review 
Narayana Nethralaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Following subjects will be included for the study:
Tear samples from Dry Eye Disease patients and healthy controls without any ocular conditions.
1. Agree to sign the IEC approved informed consent form
2. Greater than or equal to 18 years of age, of any gender, able to read and respond to the clinical questionnaires and instructions.
3. Be willing or able to provide Schirmer’s tear samples, fill out the OSDI questionnaire, undergo TBUT test and return for all study visits and to follow instructions from the study investigator and his or her staff.
4. Inclusion criteria for DED group: Patient with reported dry eye related ocular symptoms at the screening visit or with history of active dry eye disease, which has not been resolved at the time of recruitment and sample collection.
5. Those classified as dry eye (DED) must demonstrate
a. Tear film break up time (TBUT) less than 10 s
b. Schirmer’s test less than 10 mm per 5min
c. OSDI score of at least 14.
6. Inclusion criteria for tear sample controls: Those classified as healthy control and included in study must demonstrate:
a. Tear film break up time (TBUT) greater than 12 s
b. Schirmer’s test greater than 25 mm per 5min
c. OSDI score less than 12.
Aqueous humor testing in Diabetic retinopathy and controls without retinal disease undergoing cataract surgery:
1. Agree to sign the IEC approved informed consent form
2. Greater than 50 years of age, of any gender, able to read and respond to the clinical questionnaires and instructions.
3. Be willing or able to provide aqueous humor samples, disease history, treatment history and return for all study visits and to follow instructions from the study investigator and his or her staff.
Inclusion Criteria for DR:
4. Those classified as Diabetic Retinopathy must demonstrate:
a. Known history of diabetes
b. Known history of retinal changes and currently active disease evidenced by retinal OCT and fundus imaging.
c. Those with disease requiring intervention and undergoing intraocular injections
d. ETDRS clinical grade corresponding to moderate or severe NPDR or PDR (score greater than 47) with or without retinal edema requiring intravitreal intervention
5. Patients with or without systemic diabetes control, presence of nephropathy or neuropathy associated with diabetes at the time of recruitment and sample collection can be included.
6. Inclusion criteria for aqueous humor controls: Those classified as control and included in study must demonstrate
a. No retinal changes on fundus and OCT imaging
b. ETDRS clinical grading corresponding to no disease (score less than 10). 
 
ExclusionCriteria 
Details  Following subjects will be excluded for the study:
Tear samples from Dry Eye Disease patients and healthy controls without any ocular conditions.
Exclusion Criteria
1.Contact lens wear:
Discontinuation of use of contact lenses within the last 30 days prior to the Screening Visit
Unwilling to commit to no use of contact lenses for the next year
2.Pregnant or nursing or lactating
3.Participation in a study of an investigational drug or device within the 30 days preceding the Screening Visit
4.Current diagnosis of any of the following ocular conditions: ocular keratitis, acute allergic conjunctivitis, infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids), inflammation (e.g., retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis)
5.Ocular surgery including cataract or LASIK surgery, glaucoma filtration surgery, retinal surgery, within 3 months of Screening Visit
6.Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.)
7.Uncontrolled ocular or systemic disease, by patient report.
8.Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
Exclusion Criteria for Tear sample Controls
1.Presence of any ocular disease
2.Use of any ongoing or prior anti-inflammatory or steroidal treatments in the last 6 months
3.Underwent any ocular or systemic surgery in the last 3 months
4.Self reported itching or ocular surface discomfort
Exclusion Criteria for testing in Diabetic retinopathy and controls without retinal disease undergoing cataract surgery
1.Pregnant or nursing/lactating
2.Presence of advanced GA or wet AMD
3.History of intraocular/intravitreal injections or laser treatments for DR therapy in the last 6 months.
4.Participation in a study of an investigational drug or device within the 30 days preceding the Screening Visit
5.Current diagnosis of any of the following ocular conditions: ocular keratitis, acute allergic conjunctivitis, infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids), inflammation (e.g., retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis)
6.Ocular surgery including cataract or LASIK surgery, glaucoma filtration surgery, retinal surgery, within 3 months of Screening Visit
7.Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.)
8.Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
Exclusion Criteria for aqueous humor Controls
1.Presence of any ocular disease except cataract (NS1-2, without PCO)
2.Use of any ongoing or prior anti-inflammatory or steroidal treatments in the last 6 months
3.Underwent any ocular or systemic surgery in the last 3 months
4.Presence of auto-immune conditions.
5.On systemic weight loss drugs
6.Any history of trauma, retinal injury 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proposed study will help establish the utility of a rapid diagnostic kit for clinical use in ophthalmic diseases. The efficiency and short turn-around -time of the test can significantly assist screening protocols in patients across a variety of ocular conditions, to enable better patient stratification, patient selection for surgery, treatment monitoring and long-term follow up. The study is expected to also reveal the application of individual biomarkers for specific disease types.  8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/01/2026 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 prospective study will be commenced at Narayana Nethralaya eye hospital and GROW Research Laboratory, Narayana Nethralaya Foundation, Bangalore, India, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India, H. B. T. Medical College and Dr. R. N. Cooper Municipal Hospital, Mumbai, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry and M and J Institute of Ophthalmology, Civil Hospital, Ahmedabad.

Both Men and women that meet the inclusion/exclusion criteria and willing to provide written Informed Consent will be enrolled in the study.

Two groups of study participants will be recruited 
Subjects over the age of 18 years will be separated into 2 groups.
Group 1 
i.50 eyes tear samples will be collected from Healthy Subjects and used as a control.
ii.50 eyes aqueous humor samples will be collected from subjects without retinal disease undergoing cataract surgery as a control.
Group 2 
i.50 eye samples will be collected from the subjects suffering from Ocular surface Diseases (Dry Eye Disease).
ii.50 eye samples will be collected from the subjects suffering from Retinal Diseases (Diabetic Retinopathy).

200 ocular fluid samples will be studied; Approximately 300 subjects will be screened. This may include single or multiple visits of subjects based on the clinical condition and the judgement of the treating clinician.
No follow-up visits from the patients will be required in this study.
Both Men and women that meet the inclusion/exclusion criteria and willing to provide written Informed Consent will be enrolled in the study.
Tear samples and aqueous humor samples will be collected to analyze biomarkers in ocular diseases using a variant of the multiplex ELISA, specific cartridges will be obtained for the measurement of IL-1b, IL-6, IL-10, IL-17A, MMP-9, ICAM-1, VEGF-A and TNF-A. Using a variant of the multiplex ELISA, specific cartridges will be obtained for the measurement of IL-1b, IL-6, IL-10, IL-17A, MMP-9, ICAM-1, VEGF-A and TNF-A. Samples from subjects with various kinds of ocular surface and retinal conditions will be tested.
The proposed study will help to establish the utility of a rapid diagnostic kit for clinical use in ophthalmic diseases. The efficiency and short duration of the test can significantly assist screening protocols in patients across a variety of ocular conditions, to enable better patient stratification, patient selection for surgery, treatment monitoring and long-term follow up. The study is expected to also reveal the application of individual biomarkers for specific disease types.
 
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