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CTRI Number  CTRI/2022/11/047565 [Registered on: 23/11/2022] Trial Registered Prospectively
Last Modified On: 16/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Visual Outcomes following implantation of a extended vision IOL in patients with early macular degeneration  
Scientific Title of Study   " Visual Outcomes Following Implantation Of A Wave Front Shaping IOL In Patients With Early Age-related Macular Degeneration: A Prospective, interventional Case Series Study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  201, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India Ahmadabad GUJARAT 380052 India

Ahmadabad
GUJARAT
380052
India 
Phone    
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  201, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India Ahmadabad GUJARAT 380052 India

Ahmadabad
GUJARAT
380052
India 
Phone    
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  201, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India Ahmadabad GUJARAT 380052 India

Ahmadabad
GUJARAT
380052
India 
Phone    
Fax    
Email  icirc@abhayvasavada.com  
 
Source of Monetary or Material Support  
Alcon Laboratories, USA 
 
Primary Sponsor  
Name  Alcon Laboratiores USA  
Address  6201 , South freeway ,Fort Worth , Texas 76134  
Type of Sponsor  Other [Surgical Industry Global] 
 
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 Abhay R Vasavada  Raghudeep Eye Hospital  Gurukul Road, Memnagar, Ahmedabad-380052 Ahmadabad GUJARAT
Ahmadabad
GUJARAT 
079-40400909

icirc@abhayvasavada.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Iladevi Cataract & IOL Research Centre 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 
Intervention  Cataract Surgery with vivity IOL implantation  SINGLE SURGICAL INTERVENTION 
Comparator Agent  Target refraction mini monovision   Cataract Surgery with vivity IOL implantation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with uncomplicated, age related cataracts and nuclear sclerosis ranging from grade I to IV on the LOCS III grading system and pre-existing stable, early dry age-related macular degeneration. Early dry AMD will be defined based on the AREDS 2 study criteria (i.e. Multiple small drusen <63 microns or few intermediate drusen >63 - <125 microns, or pigmentary changes at macula). Only one eye of each patient will be included.

 
 
ExclusionCriteria 
Details  Choroidal neovascularization, severe dry AMD, large drusen, foveal thickness >300 microns on optical coherence tomography (OCT), macular hole on OCT, prior history of intravitreal injection / implant, other ocular comorbidities including but not limited to glaucoma, uveitis, pseudoexfoliation syndrome, zonular weakness, macular pathology, diabetic retinopathy, ocular coloboma etc. nonreactive or irregular pupil, prior ocular surgery or trauma.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Unaided and corrected distance visual acuity (LogMAR) at
4 metres on the ETDRS chart 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Unaided and corrected distance visual acuity (LogMAR) at
4 metres on the ETDRS chart 
3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   01/12/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   To be published after study completion  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Presbyopia correction in conjunction with cataract surgery has been the holy grail for cataract surgeons. Today, several multifocal (bifocal / trifocal) IOLs are available that give excellent unaided visual acuity for distance, intermediate and near vision activities. However, inherent compromises of photic phenomena and reduction in contrast sensitivity often mar the successful visual outcomes of diffractive multifocal IOLs. This has been a concern, particularly in eyes with pre-existing early, stable macular degeneration. More surgeons today prefer monofocal IOL implantation in eyes with mild retinal compromise, including early dry macular degeneration. However, recently, the non-diffractive extended range of vision IOL (Vivity) has been launched. It provides greater spectacle independence compared to monofocal IOLs and available reports show minimal to no photic phenomena as well as contrast sensitivity reduction. However, it is not yet clear whether the Vivity IOL will offer a comparable quality of distance vision and a greater range of vision without significant compromise in the quality of vision in eyes with early dry macular degeneration. The aim of this study is to evaluate unaided and best corrected visual acuity at different distances and varying contrast levels.

 
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