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CTRI Number  CTRI/2020/01/022808 [Registered on: 16/01/2020] Trial Registered Prospectively
Last Modified On: 09/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Bilateral implantation of PanOptixToric IOL in patients undergoing cataract surgery]  
Study Design  Single Arm Study 
Public Title of Study   Patient experience and satisfaction and clinical results after PanOptixToric IOL implantation in both eyes of patients undergoing cataract surgery 
Scientific Title of Study   Visual and refractive outcomes and patient satisfaction real world evaluation following bilateral implantation of AcrySof IQ PanOptixToric IOL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SRI GANESH 
Designation  CHAIRMAN AND MANAGING DIRECTOR, NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
Affiliation  NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
Address  Phaco-Refractive Department Nethradhama Super Speciality Eye Hospital, #256/14, KANAKAPURA MAIN ROAD, OPPOSITE ICICI BANK, 7TH BLOCK, JAYANAGAR, BANGALORE- 560082 KARNATAKA INDIA

Bangalore
KARNATAKA
560082
India 
Phone  9854129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SRI GANESH 
Designation  CHAIRMAN AND MANAGING DIRECTOR, NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
Affiliation  NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
Address  Phaco-Refractive Department Nethradhama Super Speciality Eye Hospital, #256/14, KANAKAPURA MAIN ROAD, OPPOSITE ICICI BANK, 7TH BLOCK, JAYANAGAR, BANGALORE- 560082 KARNATAKA INDIA

Bangalore
KARNATAKA
560082
India 
Phone  9854129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SRI GANESH 
Designation  CHAIRMAN AND MANAGING DIRECTOR, NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
Affiliation  NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
Address  Phaco-Refractive Department Nethradhama Super Speciality Eye Hospital, #256/14, KANAKAPURA MAIN ROAD, OPPOSITE ICICI BANK, 7TH BLOCK, JAYANAGAR, BANGALORE- 560082 KARNATAKA INDIA

Bangalore
KARNATAKA
560082
India 
Phone  9854129740  
Fax    
Email  phacomaverick@gmail.com  
 
Source of Monetary or Material Support  
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, BANGALORE 
 
Primary Sponsor  
Name  NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL BANGALORE 
Address  #256/14, KANAKAPURA MAIN ROAD, OPPOSITE ICICI BANK, 7TH BLOCK, JAYANAGAR, BANGALORE- 560082 KARNATAKA INDIA 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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, BANGALORE  Phaco-Refractive Department Nethradhama Super Speciality Eye Hospital, 2nd floor, OPD block #256/14, KANAKAPURA MAIN ROAD, OPPOSITE ICICI BANK, 7TH BLOCK, JAYANAGAR, BANGALORE- 560082 KARNATAKA INDIA
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AcrySof IQ PanOptixToric IOL  To characterize the visual outcomes of PanOptixToric Multifocal IOL implanted to replace the natural lens in cataract patients 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D.
2. Best Corrected Visual Acuity to be 0.2 LogMAR or lower
3. Clear intraocular media
4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures

 
 
ExclusionCriteria 
Details  1. Any active ocular disease
2. Diabetic retinopathy, retinal degenerative disorders, macular degeneration, glaucoma with field defects
3. Irregular corneal astigmatism( keratoconus/ PMD)
4. Previous intraocular and corneal refractive surgery
5. Pregnancy & Lactation
6. Traumatic , Intumescent and white Cataracts
7. Subject who have retinal pathologies or dystrophies and those who are expected to require retinal laser treatment
8. Concurrent participation in another drug or device study.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Endpoint: 3 Months post 2nd eye Surgery:-
Corrected photopic distance visual acuity (CDVA, binocular)
 
Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365 
 
Secondary Outcome  
Outcome  TimePoints 
1. Uncorrected and corrected photopic distance, intermediate and near visual acuity
2. Improvement in Quality of Life (Quality of Life Questionnaire developed by Rasch Analysis)
3. Refractive astigmatism
4. Spherical Equivalent
5. Binocular Defocus Curve 
3 Months post 2nd eye surgery Post-operative visits 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   20/01/2020 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A prospective, interventional, non-randomized, single centre study to to characterize the visual outcomes of PanOptixToric Multifocal IOL implanted to replace the natural lens in cataract patients. Trial population shall comprise of adult Indian subjects 18-70 years of age at the time of informed consent with no ocular pathology with regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D who require cataract extraction. 33 subjects fulfilling the inclusion and exclusion criteria undergoing bilateral implantation of  PanOptixToric IOL implantation (n=66) following cataract surgery to be performed by a single surgeon at Nethradhama Super Speciality Eye Hospital, will be included in the study to provide real world evidence on visual and refractive outcomes, and patient satisfaction.


 
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