| CTRI Number |
CTRI/2025/10/096369 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare the retinal image quality taken from two different OCT machines |
|
Scientific Title of Study
|
A prospective comparative observational study to assess retinal layers using Aurolab’s Retinal Optical Coherence Tomography versus Heidelberg engineering OCT |
| 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 M Sivadharsan |
| Designation |
Medical Consultant, Retina-Vitreous Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital,
207, A Block,
Department of retina and vitreous services,
1, Anna Nagar
Madurai-625020
Tamil Nadu, India
Madurai
TAMIL NADU
625020
India |
| Phone |
9791034271 |
| Fax |
|
| Email |
sivadarshan@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sivadharsan |
| Designation |
Medical Consultant, Retina-Vitreous Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital,
Shenoy Nagar,1, Anna Nagar
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9791034271 |
| Fax |
|
| Email |
sivadarshan@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sivadharsan |
| Designation |
Medical Consultant, Retina-Vitreous Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital,
Shenoy Nagar,1, Anna Nagar
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9791034271 |
| Fax |
|
| Email |
sivadarshan@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aurolab,
No 1, Sivaganga Rd, Veerapanjan,
Madurai, 625020
India |
|
|
Primary Sponsor
|
| Name |
Aurolab |
| Address |
No 1, Sivaganga Rd, Veerapanjan, Madurai, Tamil Nadu 625020 |
| Type of Sponsor |
Other [Trust] |
|
|
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 M Sivadharsan |
Aravind Eye Hospital |
207, A Block,
Department of retina and vitreous services,
1, Anna Nagar
Madurai-625020
Tamil Nadu, India
Madurai
TAMIL NADU |
9791034271
sivadarshan@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Optical Coherence Tomography |
Patients with retinal disorders will be examined using Aurolab Retinal OCT to investigate the disease/disorder progression |
| Comparator Agent |
Optical Coherence Tomography |
Patients with retinal disorders will be examined using Heidelberg engineering OCT to investigate the disease/disorder progression |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age 18 years or above
2. Patients diagnosed DR, ARMD, CNVM, Macular edema, RD and other pathologies which can be diagnosed through OCT.
3.Clear ocular media (LOCS III nuclear sclerosis 2 or below Grade 2, no significant corneal opacities) and free of floaters.
4. Pupillary dilation greater than or equal to 6 mm.
5. Ability to provide informed consent and cooperate for OCT imaging.
6. Willing to undergo imaging on both devices. |
|
| ExclusionCriteria |
| Details |
1.Dense cataract or media opacities (e.g., mature cataract, significant vitreous hemorrhage) that preclude quality of OCT imaging.
2. Eyes with severe corneal pathology or poor fixation (e.g., central leucoma, band keratopathy).
3. History of recent intraocular surgery within the past 6 weeks in either eye.
4. Active intraocular inflammation (e.g., uveitis) or infection (e.g., endophthalmitis).
5. Presence of severe nystagmus or neurological disorders affecting fixation.
6. Inability to comply with study procedures or follow instructions for imaging.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Image quality including clarity, signal strength, layer segmentation and diagnostic accuracy in comparison to standard OCT
2. Ease of use and safety of the device.
|
0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="242"
Sample Size from India="242"
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)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Bottom
of Form
OCT (Optical Coherence Tomography) has been an
important part of clinical investigation of new treatments for retinal
pathologies. It is a promising method for imaging the retina, measuring its
thickness, and displaying some features of this structure. It is useful in assessing several eye
diseases, including macular edema from various causes and abnormalities of the
vitreoretinal interface. Aurolab’s Retinal OCT functions similar to already
available OCT as a diagnostic equipment. This study is to compare the outcomes of Aurolab’s Retinal OCT with a marketed OCT, in order to evaluate the image quality and disease diagnosis
|