| CTRI Number |
CTRI/2022/02/040590 [Registered on: 24/02/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| 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
|
A trial comparing two trifocal toric intraocular lens |
|
Scientific Title of Study
|
A prospective, multicenter clinical study comparing outcomes of two trifocal toric intraocular lens |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BTVCPL-TRITORIC-2019-18 version 1.2 dated 26-Apr-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and Managing director, Netradhama Superspeciality Eye Hospital |
| Affiliation |
Netradhama Superspeciality Eye Hospital |
| Address |
Netradhama Superspeciality Eye Hospital
256/14, Kanakapura Main Road
7th Block, Jayanagar,
Bangalore-560 082
Bangalore
KARNATAKA
560082
India |
| Phone |
9845195898 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Devendrapalsingh Khalsa |
| Designation |
Head – Marketing & Clinical Affairs |
| Affiliation |
BIOTECH VISION CARE PVT. LTD |
| Address |
BIOTECH VISION CARE PVT. LTD Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058, Gujarat - India.
Ahmadabad
GUJARAT
380058
India
Ahmadabad
GUJARAT
380058
India |
| Phone |
9376178887 |
| Fax |
|
| Email |
devendra@biotechhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Devendrapalsingh Khalsa |
| Designation |
Head – Marketing & Clinical Affairs |
| Affiliation |
BIOTECH VISION CARE PVT. LTD |
| Address |
BIOTECH VISION CARE PVT. LTD Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058, Gujarat - India.
Ahmadabad
GUJARAT
380058
India
GUJARAT
380058
India |
| Phone |
9376178887 |
| Fax |
|
| Email |
devendra@biotechhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Biotech Healthcare Holdings GmbH |
|
|
Primary Sponsor
|
| Name |
Biotech Healthcare Holdings GmbH |
| Address |
Obergrundsrasse 17, 6002 Luzern, Switzerland |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Germany
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashvin Agarwal |
Dr. Agarwal Eye Hospital |
2nd Floor, Clinical research department,No.222,
TTK Road, Alwarpet,
Near Raj Park Hotel, Chennai,
Tamil Nadu 600018.
Chennai
TAMIL NADU |
9840430100
agarwal_ashvin@dragarwal.com |
| Dr Sri Ganesh |
Netradhama Superspeciality Eye Hospital |
BlOCK 2 PHACO REFRACTIVE DEPARTMENT 256/14, Kanakapura Main Road 7th Block, Jayanagar, Bangalore-560 082
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9845195898
phacomaverick@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. Agarwal eye hospital- IEC |
Approved |
| Ethics Committee, Nethradhama Super Speciality Eye Hospital, (ECR/218/Indt/KA/2014 ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AcrySof® IQ PanOptix® (Alcon Laboratories) |
Acrysof IQ Panoptix is trifocal lens. It also provides all near, distance and intermediate vision. It is manufactured by Alcon Laboratories, Inc. |
| Intervention |
OPTIFLEX TRIO (Hydrophobic Aspheric Foldable IOL) |
This lenses are designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. It is manufactured by Biotech Europe meditech Inc Limited |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Age of patient >21 years
2.Patient diagnosed with cataract
3.Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5D as per corneal topography or keratometry
4.Calculated IOL Power is within the range of the investigational IOLs
5.Patient willing to sing informed consent form
6.Clear intraocular media other than cataract
7.Female participants of child bearing potential must be willing to ensure that they use effective contraception during the study
|
|
| ExclusionCriteria |
| Details |
1.Previous intraocular or corneal surgery
2.Traumatic Cataract.
3.Pregnancy (as stated by patient) or lactation
4.Concurrent participation in another drug or device investigation
5.Irregular Astigmatism
6.Patient receiving chlorquine treatment
7.Subjects with any systemic disease that could increase operative risk or confound the outcome
8.Active ocular disease in the operative eye other than cataract
9.Vulnerable subjects
10.Corneal Astigmatism >4.5D
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses |
➢ Post-operative 1 Day
➢ Post-operative 1 Week ± 2 Days
➢ Post-operative 1 Month ± 7 Days
➢ Post-operative 3 Months ± 7 Days
➢ Post-operative 6 Months ± 14 Days
➢ Post-operative 12 Months ± 30 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the safety of two trifocal toric intraocular lenses |
➢ Post-operative 1 Day
➢ Post-operative 1 Week ± 2 Days
➢ Post-operative 1 Month ± 7 Days
➢ Post-operative 3 Months ± 7 Days
➢ Post-operative 6 Months ± 14 Days
➢ Post-operative 12 Months ± 30 Days
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="20"
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)
|
15/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/02/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OPTIFLEX TRIO Intraocular Lenses (IOLs) are Trifocal Toric hydrophobic aspheric foldable single piece posterior chamber IOLs. These IOLs are designed to be surgically implanted into the human eye as a replacement for the natural crystalline lens. These IOLs are manufactured from medical implantable grade hydrophobic material with less than 4% water content. This material has a refractive index of 1.48 at 35°C and natural yellow chromophore which blocks the UV light and filter violet light that are harmful to retina and passes desired light essential for better contrast sensitivity. It has < 2% transmission at 400 nm and ≤ 10% Cut-off at 405 nm wavelength. This global phase IV Clinical trial will compare two trifocal lenses in patients with cataract and coexisting astigmatism wishing to be treated for presbyopia. Investigational product is OPTIFLEX TRIO (Hydrophobic Aspheric Foldable IOL) and Comparator product is AcrySof® IQ PanOptix® (Alcon Laboratories). Primary objective of the study is to compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Following efficacy and safety parameters will be measured: Efficacy Parameter 1.Visual Acuity 2. Contrast Sensitivity 3. Dysphotopsia 4. Patient Satisfaction Questionnaire 5. Manifest Refraction 6. Rotational Stability 7. Astigmatism 8. Spherical Equivalent 9. High Order Aberration/Internal and Total Aberration 10. Defocus Curve 11. Reading Speed 12. Pupil Size under photopic as well as Mesopic condition 13. IOL Tilt 14. IOL Decentration 15. IOL Discoloration 16. Ophthalmoscopy 17. Slit Lamp Examination Safety Parameter: Cumulative and persistent rates of adverse events in first operative eyes in comparison to ISO 11979-7:2018 SPE historical control grid rates. 1. Cystoid macular oedema 2. Hypopyon 3. Endophthalmitis 4. Lens dislocation 5. Pupillary Block 6. Retinal Detachment 7. Secondary Surgical intervention 8. Corneal stroma oedema 9. 9. Raised IOP requiring treatment |