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CTRI Number  CTRI/2023/05/052664 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to check the safety and effectiveness of AVL200 Modular Intraocular Lens. 
Scientific Title of Study   A Prospective, Open-Label, Single-Center Study of the Safety and Effectiveness of the AVL200 Modular Intraocular Lens System. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CP101237 REVISION A Dated 29 Mar 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashvin Agarwal 
Designation  Executive Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Room No. 3, Ground Floor, Dr. Agarwals Eye Hospital, 222, TTK Road, Alwarpet

Chennai
TAMIL NADU
600018
India 
Phone  919840430100  
Fax    
Email  agarwal_ashvin@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashvin Agarwal 
Designation  Executive Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Room No. 3, Ground Floor, Dr. Agarwals Eye Hospital, 222, TTK Road, Alwarpet Chennai TAMIL NADU 600018 India

Chennai
TAMIL NADU
600018
India 
Phone  9840430100  
Fax    
Email  agarwal_ashvin@dragarwal.com  
 
Details of Contact Person
Public Query  
Name  Mukul Maurya 
Designation  Director 
Affiliation  ProClin Research Private Limited 
Address  Plot 1, Nevri Hills,Lalghati, Bhopal, Madhya Pradesh

Bhopal
MADHYA PRADESH
462001
India 
Phone  917032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
ROOM NO. 01, GROUND FLOOR, ATIA VISION, INC 550 DIVISION ST CAMPBELL CA USA 
 
Primary Sponsor  
Name  ATIA VISION,INC 
Address  ATIA VISION, INC. 550 DIVISION ST. CAMPBELL, CA 95008 USA 
Type of Sponsor  Other [Device R&D and Manufacturing Company.] 
 
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 Ashvin Agarwal  Dr. Agarwals Eye Hospital  Room No. 3, Ground Floor, Dr. Agarwals Eye Hospital, 222, TTK Road, Alwarpet
Chennai
TAMIL NADU 		 919840430100

agarwal_ashvin@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Agarwals Eye Hospital Ltd - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H258||Other age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AVL200 Modular IOL System.  The AVL200 consists of a fluid-filled shell (Base) and a monofocal spherical biconvex disk (Lens).The Lens is docked into the Base to create a Lens System. The device, Intra-ocular Lens will be Implanted at baseline i.e, 1 time and the patients will be followed up at month 1, 3, 6 and 12 postoperatively. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Visually significant cataract.
2)Best corrected distance visual acuity between 20/40 and 20/200.
3)Corneal astigmatism ≤ 1.5 diopters.
4)Potential distance visual acuity of 20/25 or better. 
 
ExclusionCriteria 
Details  1)Uncontrolled systemic disease that could increase operative risk or confound outcome.
2)Use of medication that could affect accommodation.
3)Previous corneal surgery or significant corneal abnormalities.
3)Ocular pathology or degenerative disorder having potential to impair visual acuity.
4)Pupil abnormality.
5)Intraoperative cataract surgery complications that could affect IOL implantation or positioning.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Uncorrected distance visual acuity (UCDVA) – monocular and binocular.
2)Uncorrected intermediate visual acuity (UCIVA) – monocular and binocular.
3) Uncorrected distance visual acuity (UCDVA) – monocular and binocular.
4)Distance-corrected intermediate visual acuity (DCIVA) – monocular and binocular.
5)Distance-corrected near visual acuity (DCNVA) – monocular and binocular. 		 Post-Operation Month 1,3,6,12 and 36.
 
 
Secondary Outcome  
Outcome  TimePoints 
1)Ocular adverse events (AE)
2)Secondary surgical interventions related to design characteristics of the AVL200 IOL System
3)Best-corrected distance visual acuity (BCDVA) – monocular and binocular
4)Far contrast sensitivity (mesopic, with and without glare)
5)Intraocular pressure (IOP)
6)Endothelial cell density (ECD)
 		 Throughout the study, i.e., Post Op Day 1, Week 1, Month 1, 3, 6 and 12. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/05/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The data collected in this study shall only be shared between investigators, the Sponsor, and the Sponsor’s contract research organizations (if applicable). The data shall not be included in publications or presentations without written Sponsor authorization. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a Prospective, single-center, open-label. After preoperative screening to determine eligibility, subjects will undergo cataract surgery in the first eye with implantation of the AVL200 IOL System and return for follow-up visits postoperatively. Implantation of the AVL200 in the fellow eye should be performed approximately 1 month after primary eye implantation.  The subject will return for fellow eye follow-up visit postoperatively, then follow-up on the fellow eye will occur according to the primary eye visit schedule. The AVL200 IOL System is a modular intraocular lens (IOL) consisting of a fluid-filled, shape-changing Base and a fixed-power optic Lens.  The AVL200 is intended for permanent implantation in the eye after cataract removal.  The AVL200 is designed to respond to natural accommodative forces in the eye to provide a useful range of vision at near, intermediate, and distance.

 
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