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CTRI Number  CTRI/2022/08/044802 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A clinical study of EYECRYLâ„¢ PLUS (ASHFY600) intraocular lens in patients undergoing cataract surgery. 
Scientific Title of Study   Prospective single arm, post-marketing clinical study of EYECRYLâ„¢ PLUS (ASHFY600) intraocular lens to assess performance and safety in patients undergoing cataract surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Lional Raj D 
Designation  Regional Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Dr. Agarwals Eye Hospital, 10, South Bypass Road Vannarpettai Tirunelveli - 627003 Tamil Nadu

Tirunelveli
TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Lional Raj D 
Designation  Regional Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Dr. Agarwals Eye Hospital, 10, South Bypass Road Vannarpettai Tirunelveli - 627003 Tamil Nadu

Tirunelveli
TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Public Query  
Name  Prof A Heber 
Designation  Senior Clinical Scientist 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Dr. Agarwals Eye Hospital, 10, South Bypass Road Vannarpettai Tirunelveli - 627003 Tamil Nadu

Tirunelveli
TAMIL NADU
627003
India 
Phone  9894067910  
Fax    
Email  heber75@gmail.com  
 
Source of Monetary or Material Support  
Dr. Agarwal’s Eye Hospital 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Private hospital/clinic 
 
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 
Prof Dr Lional Raj D  Dr. Agarwals Eye Hosptial  Dept. of Cataract & IOL Surgery No.10, South Bypass Road, Vannarpettai
Tirunelveli
TAMIL NADU 		 8754411261

drlionalraj@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Agarwal’s Eye Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Monofocal Hydrophobic natural yellow Acrylic Foldable Intraocular Lens.  These IOLs are designed to be surgically implanted in the human eye as a replacement for the natural crystalline lens. These IOLs are made from medical implantable grade hydrophobic material Hydrophobic material have the same refractive index of 1.48 at 35°C. Hydrophobic IOL incorporates natural yellow chromophore which absorbs the UV light and filter violet light. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age 18 year or greater
2. Cataract
3. Calculated IOL power is within the range of the study IOLs.
4. Given consent to use device related data for scientific purpose
5. Clear intraocular media other than cataract
6. Patient willing to participate and sign informed consent
7. Patient willing to come for all post-operative follow-up
8. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study 
 
ExclusionCriteria 
Details  1. Previous intraocular or corneal surgery
2. Traumatic cataract
3. Pregnancy
4. Concurrent participation or participation in the last 30 days in any other clinical trial
5. Irregular astigmatism
6. Instability of keratometry or biometry measurements
7. Vulnerable subject.
8. Patients receiving chloroquine treatment.
9. Patient having Microphthalmia.
10. Patient having Chronic Uveitis.
11. Patient suffering from Corneal dystrophy or endothelial insufficiency.
12. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

Primary outcome:
1. Monocular uncorrected distance visual acuity (UCVA)
2. Distance corrected visual acuity (BCVA)

Secondary outcome:
1. Contrast sensitivity
2. Adverse events
 		 Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days,
330-420 days, 630-780 days and 990-1140 days post
operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Contrast sensitivity
2. Adverse events
 		 Pre-operative, 1-2day, 7-14 day, 30-60 day, 120-180 day and 330-420 day, 630-780 days, 990-1140 days post operatively 
 
Target Sample Size   Total Sample Size="490"
Sample Size from India="490" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   25/08/2022 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Publication

  6. For how long will this data be available start date provided 22-07-2022 and end date provided 08-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The objectives of this study are to evaluate safety and performance of Eyecryl Plus intraocular lens in patients undergoing cataract surgery, to evaluate monocular uncorrected distance visual acuity (UCVA) and distance corrected visual acuity (BCVA) under photophic conditions and to measure the Contrast Sensitivity.


 
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