| 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
|
|
|
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
|
|
|
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. |