| CTRI Number |
CTRI/2020/08/027105 [Registered on: 13/08/2020] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Patient satisfaction and quality of vision following implantation of latest technology based Intraocular Lens implantation after cataract surgery in both eyes |
|
Scientific Title of Study
|
Clinical outcomes and quality of vision following bilateral implantation of a new
Extended Depth of Focus (EDoF) Intraocular Lens |
| Trial Acronym |
EDoF |
|
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 CMD, Netradhama Super Speciality Eye Hospital |
| Affiliation |
Nethradhama Super speciality Eye Hospital |
| Address |
256/14, Kanakapura Main Road, 7th block, Jayanagar, Bangalore 560070
256/14, Kanakapura Main Road, 7th block, Jayanagar, Bangalore 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and CMD, Netradhama Super Speciality Eye Hospital |
| Affiliation |
Nethradhama Super speciality Eye Hospital |
| Address |
256/14, Kanakapura Main Road, 7th block, Jayanagar, Bangalore 560070
256/14, Kanakapura Main Road, 7th block, Jayanagar, Bangalore 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and CMD, Netradhama Super Speciality Eye Hospital |
| Affiliation |
Nethradhama Super speciality Eye Hospital |
| Address |
256/14, Kanakapura Main Road, 7th block, Jayanagar, Bangalore 560070
256/14, Kanakapura Main Road, 7th block, Jayanagar, Bangalore 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Carl Zeiss Meditech
Carl-Zeiss-Strasse 22, 73447, Oberkochen |
|
|
Primary Sponsor
|
| Name |
Dr Sri Ganesh |
| Address |
#256/14, Kanakapura main road, 7th block, Jayanagar, Bangalore-560070 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Carl Zeiss Meditech |
Carl-Zeiss-Strasse 22, 73447 Oberkochen |
|
|
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 Superseciality Eye Hospital |
2561/14, Kanakapura main road, 7th block, Jayanagar
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: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implantation of new Extended Depth of Focus intraocular lens after cataract surgery |
The Zeiss AT LARA 829mp IOL will be implanted i patients after an uneventful cataract surgery. Its outcomes with regard to patient satisfaction and spectacle independence will be studied |
| Comparator Agent |
ZEISS AT LARA® 829MP |
ZEISS AT LARA® 829MP is the next-generation EDoF IOLs providing an even wider range of focus, as well as excellent optical performance and quality of vision |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
A patient with cataract for which phacoemulsification or femtolaser assisted cataract surgery with
posterior chamber IOL implantation
· Male or female in good general health, 40-80 years of age at the time of the pre-operative
examination
· A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL
implantation
· A patient with preoperative corneal astigmatism less than 1D and stable corneal conditions within
the last 12 months
· A patient with clear ocular media other than cataract in each eye
· A patient with normal OCT of the macula in each eye |
|
| ExclusionCriteria |
| Details |
A patient with a known pathology that may affect visual acuity (as determined by the Investigator);
particularly retinal changes that affect vision (macular degeneration, cystoid macular edema,
proliferative diabetic retinopathy, etc.) in either eye
A patient with amblyopia or strabismus
A patient with capsule or zonular abnormalities that may affect postoperative centration or tilt of the
lens (e.g. pseudoexfoliation syndrome) in either eye
A patient has a history of significant ocular trauma or prior ocular surgery in either eye
A patient with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism (e.g.
Keratoconus)
A patient that may or is expected to undergo surgical intervention and/or ocular laser treatment prior
to or during the study period in either eye
Need for a dioptre out of the range of +16.0D to +26.0D
A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic
disease is not yet stabilized will not be considered for entry into the study
A patient currently participating or has participated within 30 days prior to the start of this study in a
drug or other investigational research study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Bilateral,unilateral uncorrected distance visual acuity and Distance corrected visual
acuity with ETDRS chart at 4 m
Bilateral uncorrected and distance corrected intermediate visual acuity and reading speeds at 60 and 80 cm
with Salzburg Reading Desk(SRD)
Bilateral uncorrected and distance corrected near vision with ETDRS chart and SRD at 40 cm
Defocus curves from +2 to -3 D
Contrast sensitivity with CSV 1000 chart.
Subjective Questionnare for dysphotopsia and spectacle independence |
1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spectacle independence for distance, intermediate and near vision |
1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
08/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Through this study we would like to evaluate the clinical outcomes and quality of vision following bilateral implantation of a new Extended Depth of Focus (EDoF) Intraocular Lens - ZEISS AT LARA 829MP IOL We would like to assess the spectacle independence for near, intermediate and distant vision. |