| CTRI Number |
CTRI/2019/10/021676 [Registered on: 16/10/2019] Trial Registered Prospectively |
| Last Modified On: |
15/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL OUTCOMES OF DIFFERENT MULTIFOCAL TORIC IOLs IN ONE YEAR PROSPECTIVE CLINICAL STUDY |
|
Scientific Title of Study
|
Safety,efficacy and rotational stability of different Multifocal Toric IOLs -One Year Prospective controlled clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
chairman and MD Nethradhama Super Speciality Eye Hospital |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9845129740 |
| Fax |
26633770 |
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sri Ganesh |
| Designation |
chairman and MD Nethradhama Super Speciality Eye Hospital |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9845129740 |
| Fax |
26633770 |
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sri Ganesh |
| Designation |
chairman and MD Nethradhama Super Speciality Eye Hospital |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9845129740 |
| Fax |
26633770 |
| Email |
phacomaverick@gmail.com |
|
|
Source of Monetary or Material Support
|
| BIOTEC VISION CARE PVT. LTD Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road, Ahmedabad - 380058 , Gujarat India |
|
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Primary Sponsor
|
| Name |
Dr Sri Ganesh |
| Address |
Phaco Refractive Dept,2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082 |
| Type of Sponsor |
Other [consultant for BIOTEC Europe Meditec Inc.Ltd.INDIA] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sri Ganesh |
Nethradhama Super Speciality Eye Hospital |
# 256/14, Kanakapura Main Road,
7th Block, Jayanagar, Bangalore-560082
Bangalore
KARNATAKA |
9845129740
phacomaverick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eyecryl ACTV Diffractive Multifocal IOL |
The safety and effectiveness of Eyecryl ACTV diffractive Multifocal IOL and TECNIS Multifocal Toric IOLs implanted to replace the natural lens in cataract patients are compared |
| Comparator Agent |
TECNIS Multifocal Toric IOL |
TECNIS Multifocal Toric IOL with 3.25 near addition - corrects both astigmatism and near vision |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who has been implanted bilaterally with the Multifocal Toric IOL will be included in the Study.
2. Age 18 and older
3. Regular corneal topography and corneal astigmatism more than 0.75 D.
4. Best Corrected Visual Acuity to be 0.2 LogMAR or Lower
5. Clear intraocular media
6. Availability, willingness and sufficient cognitive awareness to comply with examination procedures
7. Patients who has given informed written consent.
|
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| ExclusionCriteria |
| Details |
1. Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism)
2. Previous intraocular and corneal surgery
3. Pregnancy & Lactation
4. Traumatic Cataract
5. Subject who are expected to required retinal laser treatment
Concurrent participation in another drug or device Study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual acuity (UCDVA & BCDVA).Visual acuity (Near & Intermediate).Toric Marks Measurement (Rotational Stability) using Itrace.Refractive astigmatism.Spherical Equivalent |
Preoperative Visit.Intraoperative Visit.Postoperative 1 Day.Postoperative 7 Days.Postoperative 30 Days.Postoperative 90 Days.Postoperative 180 Days.Postoperative 365 Days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Intraocular Pressure (IOP).Endothelial Cell Count.Pupil Size.Defocus CurveCorrected up to ± 4 D. |
Preoperative Visit.Intraoperative Visit.Postoperative 1 Day.Postoperative 7 Days.Postoperative 30 Days.Postoperative 90 Days.Postoperative 180 Days.Postoperative 365 Days |
|
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Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
28/10/2019 |
| 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
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a Prospective, comparative clinical study of 2 different Multifocal Toric IOLs i.e, Eyecryl ACTV Diffractive Multifocal IOL and TECNIS Multifocal Toric with 3.25 near addition
It is a single centre study for 1 year duration. 64 Subjects(128 eyes)-32 subject(64 eyes) in each arm will be taken.
The primary objective of this clinical study is to characterize and compare the safety and effectiveness of these 2 Multifocal Toric IOLs. |