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CTRI Number  CTRI/2024/05/066989 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To study the visual outcome after the implantation of an intraocular lens with three focal points in both eyes undergoing cataract surgery. 
Scientific Title of Study   Clinical And visual outcomes following bilateral implantation of trifocal intraocular lenses with asymmetric light distribution.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Supriya Sri Ganesh 
Designation  Executive Director 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070

Bangalore
KARNATAKA
560070
India 
Phone  8951027740  
Fax    
Email  dr.supriyasriganesh@nethradhama.org  
 
Details of Contact Person
Scientific Query  
Name  Riddhi Vora 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070

Bangalore
KARNATAKA
560070
India 
Phone  9892909009  
Fax    
Email  riddhivora99@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070

Bangalore
KARNATAKA
560070
India 
Phone  9182183107  
Fax    
Email  priya.bingi@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Supriya Sriganesh 
Address  Nethradhama Superspeciality Eye Hospital Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070 
Type of Sponsor  Other [Self] 
 
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 Riddhi Vora  Nethradhama Superspeciality Eye Hospital  Department of Phacorefractive, Building no- 256/14, Kanakapura Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070
Bangalore
KARNATAKA 		 9892909009

riddhivora99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H250||Age-related incipient cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not appliacble  not applicable 
Intervention  Surgical intervention  bilateral implanatation of intraocular lens within 15 days of each other. The time of surgery will be 10 mins per eye.  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Bilateral implantation (second eye surgery within two weeks from the first eye surgery.
Age more than 21 Years
Cataractous eyes with no comorbidity
Regular corneal topography and corneal astigmatism Patient desiring spectacle independence and having realistic expectations.
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Signed informed consent 
 
ExclusionCriteria 
Details  Active ocular disease in the operative eye
Subjects with any systemic disease that could increase operative risk or confound the outcome
Pregnant or lactating or planning a pregnancy at the time of enrolment
Any patient who is taking part in another study involving ocular surgery
Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia
Pupil abnormalities  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Monocular Uncorrected Distance Visual Acuity(UDVA) and Best Corrected Distance Visual Acuity (CDVA) using ETDRS chart at 4 meters
Monocular and Binocular Uncorrected(UIVA)and distance corrected Intermediate Visual Acuity (DCIVA) using ETDRS charts at 40, 66 and 80 cm
Manifest refraction (Sphere, Cylinder, Spherical Equivalent)
Binocular Uncorrected near (UNVA) and distance corrected near visual Acuity (DCIVA) using ETDRS charts.
 		 Post op day 1, 2 weeks, 3 Months Follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Binocular corrected defocus curve using defocusing lenses of -3.0D to +3D
Reading Speeds using Salzburg Reading Desk at preferred reading and intermediate distance
iTrace undilated.
HDA (Objective scatter index and Modulated transfer function)
Mesopic Contrast Sensitivity (FACT CSV)
Photic phenomenon by dysphotopsia questionnaire ( post op 3 months followup)
Patient satisfaction, spectacle independence and quality of vision (QOV) questionnaire ( post op 3 months followup)
Any significant adverse events intra-operatively or post-operatively at any time point, will be reported to the institutional ethics committee within a period of 48 hours.
 		 2 weeks, 3 Months Follow-up 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/05/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is an interventional study assessing the visual and clinical outcomes of bilateral implantation of trifocal intraocular lenses with asymmetric light distribution. A total of 60 eyes from 30 patients fulfilling the inclusion and exclusion criteria will be included in the study with their demographic data. Patients who underwent bilateral cataract surgery with in the bag implantation of Trifocal Intraocular lens(IOL). Biometry will be performed using the Barrett’s formula (Barrett’s formula to be used with total keratometry (TK) implemented in the IOL Master 700). We will be assessing patients distant visual acuity, intermediate visual acuity and near vision. Patients quality of vision will be tested by defcous curve, SRD, iTrace, HDA, patient satsifaction score.  
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