| CTRI Number |
CTRI/2024/04/065250 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This clinical trial is to study the digital method for eye lens to be placed during cataract surgery by comparing with the manual method |
|
Scientific Title of Study
|
An Open-label, Prospective, Randomized, Multi-Center, Clinical Trial Designed to Evaluate the Clinical Outcomes with Digital Workflow Solution Versus Conventional Workflow Solution Refractive Outcomes Among Patients Undergoing Cataract Surgery with Toric Intraocular Lens |
| Trial Acronym |
TORBI-CARIN-2024 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Merle Fernandes |
| Designation |
Principal Investigator |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Room no 606A, 6th Floor, LV Prasad Eye Institute, LV Prasad Marg, Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
7730020304 |
| Fax |
|
| Email |
merle@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channa Basavanna G Halasagi |
| Designation |
Medical Monitor |
| Affiliation |
Invitro Research Solutions Pvt. Ltd. |
| Address |
Invitro Research Solutions Pvt.Ltd. Clinical Development
Department, Medical Monitoring Divison, Room No.301,3rd Floor, No.22&23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
|
| Email |
channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijay Bhaskar |
| Designation |
Director- Clinical Development |
| Affiliation |
Invitro Research Solutions Pvt. Ltd. |
| Address |
Invitro Research Solutions Pvt. Ltd. Clinical Development
Department, Clinical Operations Divison, 3rd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
636675282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Center for Application Research in India (CARIn) Carl Zeiss India |
|
|
Primary Sponsor
|
| Name |
Center for Application Research in India (CARIn) Carl Zeiss India |
| Address |
Carl Zeiss India (Bangalore) Pvt Ltd. Plot No. 3, Jigan Link Road, Bommasandra Industrial Area Bangalore 560 099. India. |
| Type of Sponsor |
Other [Medical Technology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Merle Fernandes |
L V Prasad Eye Institute, Kallam Anji Reddy Campus |
L V Prasad Eye Institute, Kallam Anji Reddy
Campus, L V Prasad Marg, Road No.02, Banjara Hills, Hyderabad- 500034
Hyderabad
TELANGANA |
7730020304
merle@lvpei.org |
| Dr Naren Shetty |
Narayana Nethralaya |
121/C,Chord Road,Near Iskcon Temple, 1st Block,Rajajinagar, Bangalore, Karnataka 560010
Bangalore
KARNATAKA |
9900900204
drnarenshetty@narayananethralaya.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| L V Prasad Eye Institute Ethics Committee |
Approved |
| Narayana Nethralaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H252||Age-related cataract, morgagnian type, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital axis overlay for Toric IOL orientation |
The CALLISTO® Eye within the digital cataract workflow allows for digital overlay of the axis to enable Toric IOL orientation inside the capsular bag without the need for manual axis marking. In this study we compare the postoperative refractive outcome following use of CALLISTO® Eye digital overlay versus the conventional manual axis marking for Toric IOL orientation. The time duration will be 5-10 minutes. |
| Comparator Agent |
Manual axis marking for Toric IOL orientation |
The CALLISTO® Eye within the digital cataract workflow allows for digital overlay of the axis to enable Toric IOL
orientation inside the capsular bag without the need for manual axis marking. In this study we compare the postoperative
refractive outcome following use of CALLISTO® Eye digital overlay versus the conventional manual axis marking for Toric IOL orientation. The time duration will be 5-10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with regular corneal astigmatism greater than 0.75D willing to undergo cataract extraction. Patient willing to undergo cataract surgery with implantation of an Toric intraocular lenses. Patient giving full and free consent for involvement in the study. Patient willing to come for follow up study visits and measurements. |
|
| ExclusionCriteria |
| Details |
Any ocular pathology or degeneration that could have impact on vision and/or a contradiction to Toric IOL implantation.
Any surgical complication felt to in any way impact upon the quality of visual outcome.
Any other comorbid conditions or risk factors that may affect the surgical procedure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| One-month postoperative refraction |
1 week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Uncorrected & best corrected visual acuity by log MAR visual acuity 1 month. IOL axis alignment, immediate postop, 1 day postop & 1 month postop. |
1 week & 1 month. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
11/04/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
An Open-label, Prospective, Randomized, Multi-Center, Clinical Trial Designed to Evaluate the Clinical Outcomes with Digital Workflow Solution Versus Conventional Workflow Solution Refractive Outcomes Among Patients Undergoing Cataract Surgery with Toric Intraocular Lens, Sponsor name-Center for Application Research in India (CARIn) Carl Zeiss India (Bangalore) Pvt Ltd Bangalore, India. Sample size is 80 subjects of which 40 subjects will receive Digital Workflow Solution and rest 40 subjects will receive Conventional Workflow Solution, Where the primary end point is Primary endpoints: One-month postoperative manifest refraction. Secondary Endpoints: Uncorrected and best-corrected visual acuity by log MAR visual acuity: 1 month, IOL axis alignment: immediate postop; 1-day postop, and 1 month postop. The Exploratory Endpoints: Time to manually mark IOL axis prior to surgery by the surgeon, before drops used (patient prep time, # drops, time for axis marking at slit lamp, patient transport to OR), Total surgery time for cataract extraction and Toric IOL implantation, Time for IOL alignment during surgery. |