| CTRI Number |
CTRI/2022/01/039593 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Safety and performance of Intraocular Lens |
|
Scientific Title of Study
|
Prospective, open-label, single-arm, multicentre, observational, post-marketing clinical study to evaluate safety and performance of Toric hydrophilic Acrylic Intraocular Lens (IOL) (Omni Lens Pvt. Ltd.) in patients who require IOL implantation during routine cataract surgery. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EUP-OML-21-005 Version 1.0 Dated 12-Oct-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jatin Soni |
| Designation |
Head- Clinical Operations & Project Management |
| Affiliation |
Eupraxia Centre For Clinical Excellence LLP |
| Address |
205, Spentha Complex,
Race Course, Opposite Pizza Hut,
Vadodara-390007, Gujarat, India
Vadodara
GUJARAT
390007
India |
| Phone |
9630635333 |
| Fax |
|
| Email |
jsoni@eupraxiaconsulting.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Soni |
| Designation |
Head- Clinical Operations & Project Management |
| Affiliation |
Eupraxia Centre For Clinical Excellence LLP |
| Address |
205, Spentha Complex,
Race Course, Opposite Pizza Hut,
Vadodara-390007, Gujarat, India
GUJARAT
390007
India |
| Phone |
9630635333 |
| Fax |
|
| Email |
jsoni@eupraxiaconsulting.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin Soni |
| Designation |
Head- Clinical Operations & Project Management |
| Affiliation |
Eupraxia Centre For Clinical Excellence LLP |
| Address |
205, Spentha Complex,
Race Course, Opposite Pizza Hut,
Vadodara-390007, Gujarat, India
GUJARAT
390007
India |
| Phone |
9630635333 |
| Fax |
|
| Email |
jsoni@eupraxiaconsulting.com |
|
|
Source of Monetary or Material Support
|
| Omni Lens Pvt. Ltd.
5 “Samruddhiâ€, Opp. Sakar-III,
Nr. Sattar Taluka Society, Navrangpura,
Ahmedabad – 380014,
Gujarat (India)
|
|
|
Primary Sponsor
|
| Name |
Omni Lens Pvt Ltd |
| Address |
5 “Samruddhiâ€, Opp. Sakar-III,
Nr. Sattar Taluka Society, Navrangpura,
Ahmedabad – 380014,
Gujarat (India)
|
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anshulee Sood |
Tejas Eye Hospital Run by Divyajyoti Trust |
Suthar Falia, Opp. Hanuman Temple,
At & Po. Mandvi, Dist.: Surat-394160, Gujarat, India
Surat
GUJARAT |
8447526636
anshuleesood@gmail.com |
| Dr Uday R Gajiwala |
Tejas Eye Hospital Run by Divyajyoti Trust |
Suthar Falia, Opp. Hanuman Temple,
At & Po. Mandvi, Dist.: Surat-394160, Gujarat, India
Surat
GUJARAT |
9426125947
divyajyoti.icare@gmail.com |
| Dr Uma Shroff |
Tejas Eye Hospital Run by Divyajyoti Trust |
Suthar Falia, Opp. Hanuman Temple,
At & Po. Mandvi, Dist.: Surat-394160
Surat
GUJARAT |
9426125947
divyajyoti.icare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Divyajyoti Trust-Tejas Eye Hospital |
Approved |
| Institutional Ethics Committee,Divyajyoti Trust-Tejas Eye Hospital |
Approved |
| Institutional Ethics Committee,Divyajyoti Trust-Tejas Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z961||Presence of intraocular lens, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NONE |
| Intervention |
Toric Hydrophilic Acrylic Intraocular Lens (Omni Lens Pvt. Ltd.) |
Dose: NA,
Frequency: NA,
Route of Administration: Intraocular,
Duration of Therapy: One time insertion.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged greater than or equal to 40 at the time of enrolment
2. A patient who receive Toric Hydrophilic Acrylic IOL (Omni Lens Pvt.
Ltd.) as per the instruction mentioned in instructions for use (IFU) of
the study device during routine cataract surgery
3. Clear intraocular media other than cataract
4. Calculated IOL power is within the range of the Study device
5. Corneal astigmatism greater than equal to 0.75 D and less than equal to 6.00 D
6. Dilated pupil size large enough to visualize TIOL axis markings
postoperatively
7. The patient or his/her legally authorized representative (if applicable)
agrees to provide written informed consent
8. The patient is willing to comply with protocol specified follow-up
Evaluations
|
|
| ExclusionCriteria |
| Details |
1. Patient with contraindications for TIOL mentioned in the IFU of the
study device
2. Previous intraocular or corneal surgery
3. Traumatic cataract
4. Pregnancy or lactation
5. Instability of keratometry or biometry measurements
6. Irregular astigmatism
7. Currently participating in another clinical study with experimental
drugs or devices
8. Unsuitable for study participation for any other reason, as determined
by Investigators clinical judgment (reason to be documented on CRF)
9. Active SARS-CoV-2 infection known to Patient at the time of
enrolment in the study/ patients having signs and symptoms of SARSCoV-
2 infection at the time of enrolment
Patients shall be discontinued when certain conditions are present at the time
of surgery, including:1
zonular instability;
need for iris manipulation;
capsular fibrosis or other opacity and
inability to fixate IOL in the desired position.
In such cases, the patient shall be followed until the condition has stabilized.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Best-Corrected Distance Visual Acuity (BCDVA) |
[Time frame: visit 4] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in cylindrical power of the eye [Time frame: visit 4,
visit 5]
2. Rotational stability [Time frame: visit 4] - Rotational stability will be evaluated by IOL axis mark rotation at
visit 4.
3. Best-Corrected Distance Visual Acuity (BCDVA) compared to
historical Data of EN ISO 11979-7:2018, Annex E (Table E.3
and E.4) [Time frame: Pre-op, visit 2, visit 3, visit 4, visit 5]
4. Adverse event rates [Time frame: Baseline, visit 1, visit 2, visit 3,
visit 4, visit 5]
|
[Time frame: visit 4] |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
20/01/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prospective, open-label, single-arm, multicentre, observational, post-marketing
clinical study to evaluate safety and performance of Toric hydrophilic Acrylic
Intraocular Lens (IOL) (Omni Lens Pvt. Ltd.) in patients who require IOL
implantation during routine cataract surgery. |