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CTRI Number  CTRI/2024/12/078722 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A Real-World Study on Vision Quality and Patient Satisfaction After Naturo Lens Implantation During Cataract Surgery. 
Scientific Title of Study   A prospective multi centre real world clinical study with objective and subjective evaluation of visual performance, patients’ satisfaction after “Naturo” trifocal diffractive hydrophilic intraocular Lens implantation with phacoemulsification 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PRPL-NATURO-02-2024 Date- 24-Aug-2024, Version 1.0  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. 14, Groud floor, Dr Agarwals Eye Hospital ltd. Main Hospital No. 222, TTK Road, Alwarpet

Chennai
TAMIL NADU
600018
India 
Phone  9840430100  
Fax    
Email  agarwal_ashvin@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Navonil Sau 
Designation  Medical Advisor- Clinical Operation 
Affiliation  ProClin Research Pvt Ltd 
Address  2nd floor, Plot no. 1, Nevri Hills, Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  9051064041  
Fax    
Email  navonil.sau@proclinresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukul Maurya 
Designation  Director, ProClin Research Pvt Ltd 
Affiliation  ProClin Research Pvt Ltd 
Address  2nd floor, Plot no. 1, Nevri Hills, Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  7032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
CARE GROUP INDIA, Block No.310, Village Sim of Dabhasa Taluka – Padra, Vadodara - 391 440, Gujarat, India  
 
Primary Sponsor  
Name  CARE GROUP INDIA 
Address  Block No.310, Village Sim of Dabhasa Taluka – Padra, Vadodara - 391 440, Gujarat, India 
Type of Sponsor  Other [Opthalmic- CARE GROUP INDIA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Kumar  Dr Agarwals Eye Hospital  Room no 1, 1st Floor,Dr Agarwals Eye Hospital, SCO 833 & 834 Sector 22A, opposite Parade Ground, Sector 17, Chandigarh
Chandigarh
CHANDIGARH 		 8054001197

ashokrpc@yahoo.com 
Dr Ashvin Agarwal  Dr Agarwals Eye Hospital  Room no. 14, Groud floor, Dr Agarwals Eye Hospital ltd. Main Hospital No. 222, TTK Road, Alwarpet
Chennai
TAMIL NADU 		 9840430100

agarwal_ashvin@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC Dr Agrawals Health Care  Approved 
IEC Dr Agrawals Health Care, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H269||Unspecified cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NATURO IOL   Naturo is a High-Performance Extended Depth Aspheric Optic Panfocal IOL. It is manufactured by EDGE less Phase Matching Technology utilizing 100% light for achieving sharp, bright, excellent contrast vision at all working distances. Its Dual Haptic design ensures also better stability and centration in the capsular bag minimizing the concentric forces to be transferred from the haptic to the optics of the lens. The device, Intra-ocular Lens will be Implanted at Visit 1 (day 0) and the patients will be followed up at visit 2 (day 1),day 7, 1,3 and 6 month.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age 21 years or older at the time of the preoperative visit
2. Visually significant cataract in one or both eyes and willingness to have them surgically removed
3. Clear intraocular media other than cataract in both eyes (vitreous, anterior chamber)
4. Monocular Best Corrected Distance Visual Acuity (BCDVA) in the operative eye between 20/40 and 20/200,
5. Corneal astigmatism less than or equal to 0.75 D in the operative eye
6. Regular corneal topography and corneal astigmatism
7. Spontaneously expressing the desire for spectacle independence after surgery and with realistic expectation
8. Potential for postoperative corrected distance visual acuity 20/25 (logMAR 0.10) or better in the operative eye
9. IOL power to reach emmetropia from 16.0 D to 26.0 D, inclusive, for the operative eye
10. Willingness to provide signed written consent prior to participation in any study related procedures
11. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits. 
 
ExclusionCriteria 
Details  PRE-OPERATIVE
1. Age of patient less than 21 years
2. Active Ocular disease in the operative eye for example chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency
3. Subject with any systemic disease that could increase operative risk or pull found the outcome
4. Pregnant or lactating or planning a pregnancy at the time of enrolment
5. Significant irregular corneal astigmatism
6. Any ocular Co morbidity, amblyopia, axial length more than 25.0 mm
7. Pupil abnormality (non-reactive Tonic pupil, abnormally shaped pupil or pupil that do not dilate under mesopic or scotopic condition) patient on chloroquine treatment
8. Degenerative ocular disorder (macular degeneration, optic nerve atrophy, retinal disorder, corneal guttata, post keratoplasty, corneal scarring,aniridia, amblyopia, previous intraocular surgery (corneal glaucoma or vitreo-retinal surgery) pseudoexfoliation syndrome, intra ocular tumour
9. Any patient who is taking part in another study involving ocular surgery
10. Subject is an employee or immediate family member of Sponsor or investigator’s
study staff
INTRA-OPERATIVE
1. Complications occurring during cataract extraction surgery (e.g., torn anterior capsule; posterior capsular rupture, corneal injury such as significant detachment of Descemet’s membrane or significant corneal endothelial damage, inability to adequately remove the crystalline lens material,
2. Vitreous loss or prolapse
3. Zonular weakness, dehiscence or rupture
4. Any capsular bag pathology, fibrosis, or opacification that could not be visualized prior to removing the cataract
5. Any method of anterior capsulotomy other than specified in the protocol (Continuous Curvilinear Capsulorhexis)
6. Significant anterior chamber bleeding
7. Wound burn
8. Pupil diameter less than 6 mm post mydriatic injection
9. Capsulorhexis less than 5 mm and more than 6.5 mm in diameter will be excluded
10. Iris incarceration or damage, excessive iris mobility, or need for iris manipulation prior to or at the time of implantation
11. Mechanical or surgical manipulation required to enlarge pupil prior to or at the time of IOL implantation
12. Any complication that may affect the postoperative lens centration or tilt or that may require additional interventional procedures for correction
13. Lens Element damage
14. Inability to fixate the IOL in the desired position
 
 
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 (UDVA) with ETDRS chart
2. Corrected distance visual acuity (CDVA) with ETDRS chart
3. Distance corrected intermediate visual acuity (DCIVA) with ETDRS chart
4. Uncorrected intermediate visual acuity (UIVA) with ETDRS chart
5. Distance corrected near visual acuity (DCNVA) with ETDRS chart
6. Contrast sensitivity
7. Photic phenomena by dysphotopsia questionnaire 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Quality of Vision Index (QVI)
2. Spherical equivalent
3. Defocus curve
4. subjective refraction
5. visual disturbance
6. patient satisfaction
7. spectacle independence (NEI_VFQ25 questionnaire) at 6 months
8. reading speed
9. manifest refraction 		 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   08/01/2025 
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="0"
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   Diffractive trifocal IOLs have been recently introduced to solve the aforementioned problem. Diffractive trifocal IOLs have three foci and, hence, provide a wider range of spectacle independence, especially at an intermediate distance, than bifocal IOLs. Which shows promising technology for obtaining good visual outcomes and spectacle independence in patients at different distances while minimizing visual disturbances. These lenses are intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near, intermediate and far visual functions, and reduced spectacle dependence. The study follow up will be Day0, Day1, day 7, 1,3 and 6 months comprises pre-operative, operative and post operative phase. These lenses are intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near, intermediate and far visual functions, and reduced spectacle dependence. 
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