FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062774 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Post-marketing clinical study to assess clinical performance and safety of EYECRYL Sert intraocular lens (IOL) versus TECNIS EyhanceTM IOL in patients with planned age-related cataract surgery. 
Scientific Title of Study   A Prospective, randomized, controlled, post-marketing clinical study to assess clinical performance and safety of EYECRYL Sert intraocular lens (IOL) versus TECNIS EyhanceTM IOL in patients with planned age-related cataract surgery 
Trial Acronym  EYECRYL_Sert 
Secondary IDs if Any  
Secondary ID  Identifier 
BTVCPL-EDOF-2023-02,Version: 01 dated 27 Nov 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishnaprasad Kudlu 
Designation  M.S Opthalmology 
Affiliation  Prasad Netralaya Super Speciality Eye Hospital 
Address  Prasad Netralaya Super Speciality Eye Hospital Udupi Karnataka
Prasad Netralaya Super Speciality Eye Hospital Udupi Karnataka
Udupi
KARNATAKA
576101
India 
Phone  9845102334  
Fax    
Email  Krishprasadk73@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepa Arora 
Designation  CEO 
Affiliation  Chief Executive Officer 
Address  Office No. 1401 The Affaires Palm Beach RoadSector 17, Sanpada Navi Mumbai, Maharashtra, India- 400705
Office No. 1401 The Affaires Palm Beach RoadSector 17, Sanpada Navi Mumbai, Maharashtra, India- 400705
Mumbai
MAHARASHTRA
400705
India 
Phone  8291351946  
Fax    
Email  deepaarora@clinexel.com  
 
Details of Contact Person
Public Query
 
Name  Mr Bhargav Joshi 
Designation  Sr. Manager- Clinical Affairs 
Affiliation  Biotech Vision Care Pvt Ltd 
Address  Biotech Vision Care Pvt Ltd Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India
Ahmadabad
GUJARAT
380058
India 
Phone  9925925667  
Fax    
Email  bhargav.joshi@biotechhealthcare.com  
 
Source of Monetary or Material Support  
Biotech Vision Care Pvt. Ltd. Gujarat India 
 
Primary Sponsor  
Name  Biotech Vision Care Pvt Ltd 
Address  Biotech Vision Care Pvt. Ltd.Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India 
Type of Sponsor  Other [Medical Device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kishore Pahuja  Natasha Eyecare and Research Centre  Sai Saheb, Shiv Sai Lane, Pimple Saudagar Pune Room No 01 2nd Floorepartment of Ophthalmology, Retina Division
Pune
MAHARASHTRA 
9890086862

kishorepahuja@gmail.com 
Dr Varsha Mangiraj   PBMA’s H. V. Desai Eye Hospital  93, Tarawade Vasti, Mohammadwadi Road, Hadapsar, Pune -411060 Room no.: 214 Floor: Ground Floor Department: Dharamsey Nancy Building
Pune
MAHARASHTRA 
9049621680
9049621680
varsharp83@gmail.com 
Dr Krishnaprasad Kudlu  Prasad Netralaya Super Speciality Eye Hospital  Cataract and Refractive Department Room No.1
Udupi
KARNATAKA 
9845102334

krishprasaddk73@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Nethrajyothi Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EYECRYL Sert   Preloaded monofocal Hydrophobic Aspheric EDOF (Extended depth of focus) lensTotal Expected duration of clinical Study approx 22 months 
Comparator Agent  TECNIS EyhanceTM  Foldable 1-piece acrylic posterior chamber intraocular lens Total Expected duration of Clinical Study Approx 22 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients having cataract;
2.Female participants of childbearing potential and male participantswhose partner is of childbearing potential must be willing to ensure thatthey or their partner use effective contraception during the study 
 
ExclusionCriteria 
Details  1.Systemic disease that could increase the operative risk or confound the outcome
2.Instability of keratometry or biometry measurements and
3.irregular astigmatism 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that EYECRYL Sert exhibits non inferiority for Distance
Corrected Intermediate Visual Acuity (DCIVA) over TECNIS EyhanceTM 
1-2days,
7-14 days,
30-60 days,
120-180 days
330-420 day 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate that EYECRYL Sert has at least 50% eyes achieving photopic
monocular DCIVA 0.2 logMAR or better @ 66cm  

120-180 days  
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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)   05/03/2024 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Presbyopia is one of the most common causes of vision impairment, affecting an estimated 2 billion people, globally . Presbyopia has been associated with negative impacts on quality of life in people aged 40 and above from developing and developed nations alike – because it causes difficulties with reading and with accomplishing near vision tasks. 
Non-invasive methods of correcting presbyopia have been used for many years. While bifocal or multifocal progressive addition lenses, monofocal or bifocal contact lenses can provide satisfactory distance and near vision to presbyopes without the potential risks of a surgical procedure, they cannot restore or substitute the true process of accommodation of a younger individual. 
Among the surgical options, presbyopia correction can be achieved with excimer or femtosecond laser ablation on cornea (LASIK, PRK, Presbylasik, Supracor, Intracor, etc.), Another recent corneal approach is the insertion of inlays, both artificial and made of corneal tissue in order to change the central curvature of the cornea. 
Lens extraction with implantation of multifocal, monofocal (monovision) or accommodative intraocular lenses is another method for correction of presbyopia and has started to become the preferred method for presbyopic correction, particularly in a cataract-aged population. Multifocal IOLs provides good distance and near vision but usually provide not sufficient intermediate vision . Moreover, they might be linked to visually significant light-related experiences that could be highly uncomfortable and necessitate extremely careful patient selection. Therefore, monofocal IOLs continue to be the most commonly used intraocular lenses in cataract surgery. However, there exists a need for an IOL that can provide a favorable compromise between clear distance and intermediate vision, while also addressing issues related to light sensitivity. 
The introduction of the newest IOLs with extended depth of focus (EDOF) technology facilitated a relatively favorable visual performance across intermediate, far, and near distances. 
 This study seeks to compare a new Advanced Monofocal IOL with extended depth of focus vision, the EYECRYL Sert intraocular lens with the TECNIS EyhanceTM IOL.
 
Close