| CTRI Number |
CTRI/2025/06/088473 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
use of Ocumap software |
| Study Design |
Other |
|
Public Title of Study
|
OcuMap – An Medical Decision Making tool for Intraocular Lens Selection |
|
Scientific Title of Study
|
OcuMap – A surgical Medical Decision-Making tool for Intraocular Lens Selection |
| Trial Acronym |
OcuMap |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathyan Parthasarathi |
| Designation |
Director |
| Affiliation |
SATHYAN EYE CARE HOSPITAL & COIMBATORE GLAUCOMA FOUNDATION, |
| Address |
#77, Om Sakthi Nagar, Off Trichy Road, Sowripalayam Pirivu, Ramanathapuram, Coimbatore
Coimbatore
TAMIL NADU
641045
India |
| Phone |
9443259148 |
| Fax |
|
| Email |
dr.sathyan.p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathyan Parthasarathi |
| Designation |
Director |
| Affiliation |
SATHYAN EYE CARE HOSPITAL & COIMBATORE GLAUCOMA FOUNDATION, |
| Address |
#77, Om Sakthi Nagar, Off Trichy Road, Sowripalayam Pirivu, Ramanathapuram, Coimbatore
Coimbatore
TAMIL NADU
641045
India |
| Phone |
9443259148 |
| Fax |
|
| Email |
dr.sathyan.p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnakumar venkateswaran |
| Designation |
Engineer |
| Affiliation |
SATHYAN EYE CARE HOSPITAL & COIMBATORE GLAUCOMA FOUNDATION, |
| Address |
#77, Om Sakthi Nagar, Off Trichy Road, Sowripalayam Pirivu, Ramanathapuram, Coimbatore
Coimbatore
TAMIL NADU
641045
India |
| Phone |
6238726730 |
| Fax |
|
| Email |
krishna.venkat70@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
OCULOTIX Inc |
| Address |
801 Hermosa Way, Menlo Park, CA 94025 |
| Type of Sponsor |
Other [software developers] |
|
|
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 Sathyan Parthasarathi |
SATHYAN EYE CARE HOSPITAL & COIMBATORE GLAUCOMA FOUNDATION |
#77, Om Sakthi Nagar, Off Trichy Road, Sowripalayam Pirivu, Ramanathapuram, Coimbatore - 641045,
Coimbatore
TAMIL NADU |
9443259148
dr.sathyan.p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Satyan Eye Care Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting for cataract surgery |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Phase 1: Ocumap data feeding phase: Validation of Ocumap engine after training and validation using subset.
• Phase 2: Ocumap recommendations: Proportion of patients receiving IOL such as advanced monofocal, extended range of vision, Trifocal or Bifocal intraocular lens ; toric and non-toric versions of each lens included
|
Screening visit, Month 3 after implant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Surgeon time with patient during preoperative visit(s)
• Surgeon satisfaction with Ocumap, including
o Time to determine selection of intraocular lens
o Accuracy of Ocumap predictions
o Ocumap ease of use
o Utility of Ocumap and Ocumap lite for staff education
• Comparison of predicted and actual patient satisfaction with vision outcomes for distance vision, near vision, night vision, dysphotopsia and overall quality of vision
• Ease of use by the patient of patient reported outcome software application
|
Screening visit, Month 3 |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="15000"
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)
|
16/06/2025 |
| 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="1"
Months="0"
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
|
All data generated as a result of this assessment will be regarded as confidential, until appropriate analysis and review by the Investigator(s) are completed. The results of the assessment may be published or presented by the Investigator(s) after the review and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to the Investigator(s) or its designee, for comment. Such comments shall aim to ensure the scientific integrity of the proposed publications and/or presentations and ensure that the data and material and activities receive fair, accurate, and reasonable presentation. |