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
|
|
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
|
|
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. |