| CTRI Number |
CTRI/2025/08/092223 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Comparing New Technologies and Expert Evaluation for Diagnosing Dry Eye Disease |
|
Scientific Title of Study
|
Diagnostic Performance of Novel OSDx Device, OSA Plus System, and Clinical Expert in the Evaluation of Dry Eye Disease |
| 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 Virender Singh Sangwan |
| Designation |
MD, Director Translational Research and Innovation Department |
| Affiliation |
Dr Shroffs Charity Eye Hospital |
| Address |
5027, Kedarnath Road, Daryaganj New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9849294656 |
| Fax |
|
| Email |
drsangwan.lvpei@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramkailash Gujar |
| Designation |
Scientist, Department Stem Cell Lab |
| Affiliation |
Dr Shroffs Charity Eye Hospital |
| Address |
5027, Kedarnath Road, Daryaganj New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9818306116 |
| Fax |
|
| Email |
ramkailash.gujar@sceh.net |
|
Details of Contact Person
Public Query
|
| Name |
Ranjitha K |
| Designation |
Associate Optometrist |
| Affiliation |
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
Bangalore
KARNATAKA
560058
India |
| Phone |
9113964481 |
| Fax |
|
| Email |
Ranjitha.k@remidio.com |
|
|
Source of Monetary or Material Support
|
| Remidio Innovative Solutions Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Remidio Innovative Solutions Pvt Ltd |
| Address |
No 1 51 2 By 12 Vacuum Techniques Compound First Cross Road Phase One Peenya Bengaluru Karnataka 560058 |
| Type of Sponsor |
Other [Medical Equipment Manufacturer] |
|
|
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 Virender Singh Sangwan |
Dr Shroffs Charity Eye Hospital |
Ocular surface Diagnostics room Number 5027 Kedarnath Road Daryaganj New Delhi 110002, India
New Delhi
DELHI |
9849294656
drsangwan.lvpei@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Shroffs Charity Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H188||Other specified disorders of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
OSA Plus |
Participants will undergo diagnostic evaluation using the OSA Plus device to assess its diagnostic performance for Dry Eye Disease (DED). Control group participants with no dry eye symptoms may be included for baseline comparison of diagnostic specificity. The total duration of the intervention will be approximately 10 minutes per participant. |
| Intervention |
OSDx |
Participants will undergo diagnostic evaluation using the OSDx device to assess its diagnostic performance for Dry Eye Disease (DED). The total duration of the intervention will be approximately 5 minutes per participant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Normals and dry eye subjects (based on OSDI score) |
|
| ExclusionCriteria |
| Details |
Subjects who are pregnant and nursing
Subjects with recent eye surgery or trauma
Individuals with uncontrolled systemic diseases such as diabetes autoimmune disorders or Sjogrens syndrome which can contribute to dry eye
Subject with ocular diseases such as Glaucoma Diabetic Retinopathy Cataract ARMD Uveitis infections and inflammation
Subjects undertaking medication like Antihistamines Beta-blockers Antidepressants or other Glaucoma medications for example prostaglandin analogs which may affect tear film structure or quality |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Definition: Diagnostic accuracy of OSDx compared to Clinical expert and predicate device (OSA plus)
Measurement: Sensitivity, specificity, positive and negative predictive values |
At the time of a single clinical visit (Day 0); repeat testing in 20% of participants within 1–7 days to assess test–retest reliability |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of OSDx & predicate device parameters (TMH, MG loss %, blink rate analysis, & Lipid Layer Thickness).
Differences in diagnostic parameters between OSDx & predicate device (e.g., mean TM ROC, MGD, etc.).
Agreement between device-based diagnoses (OSDx & predicate device) & clinical expert diagnosis.
Classification performance of the OSDx & predicate devices in subgroups of dry eye severity.
Inter & Intra observer repeatability in subset of participants for OSDx device. |
Repeat testing within 1–7 days from initial visit (only in 20% subset) rest everything will be done at the time of single diagnostic visit (Day 0) |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
19/08/2025 |
| 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)
|
Open to Recruitment |
| 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 and reliability of a novel device called OSDx in the assessment of Dry Eye Disease. The performance of OSDx will be compared with a predicate device, OSA Plus, and with the clinical diagnosis made by an expert ophthalmologist. Parameters such as tear meniscus height, meibomian gland loss percentage, blink rate, and lipid layer thickness will be analyzed. Sensitivity, specificity, predictive values, and agreement among diagnostic methods will be assessed. Repeat testing in a subset of participants will be performed to evaluate intra and inter observer repeatability. All assessments will be conducted during a single clinic visit, with follow-up testing for reliability in a small subset within seven days. |