FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/106488 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Quality of vision in patients receiving Penta focal and trifocal Intraocular Lens for Enhanced near, Intermediate, distant vision after cataract surgery 
Scientific Title of Study   A Prospective, Randomized, Comparative, Post-marketing clinical study to assess and compare the clinical outcomes and patient satisfaction of two Intraocular Lenses - pentafocal and trifocal IOLs following bilateral implantation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lional Raj D 
Designation  Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  No.15, South Bypass Road, Vannarpettai Tirunelveli

Tirunelveli
TAMIL NADU
627003
India 
Phone  918754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lional Raj D 
Designation  Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  No.15, South Bypass Road, Vannarpettai Tirunelveli


TAMIL NADU
627003
India 
Phone  918754411261  
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  No.15, South Bypass Road, Vannarpettai Tirunelveli

Tirunelveli
TAMIL NADU
627003
India 
Phone  919894067910  
Fax    
Email  clinicalresearch@dragarwal.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lional Raj D  Dr. Agarwals Eye Hospital  No.15, South Bypass Road, Vannarpettai Tirunelveli Tirunelveli 627003
Tirunelveli
TAMIL NADU 		 918754411261

drlionalraj@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Agarwals 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  Intensity Pentafocal IOL  The patient undergoing cataract surgery via phacoemulsification is implanted with a hydrophobic pentafocal intraocular lens. 
Comparator Agent  PanOptix Trifocal IOL  The Study patient undergoing cataract surgery via phacoemulsification is implanted with a hydrophobic trifocal intraocular lens.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age 18 year or greater
2. Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
3. Patients with axial length of 22 - 24.5mm
4. Normal corneas with less than 1.00 D of regular corneal astigmatism
5. Post-operative best corrected visual acuity projected to be 0.3 log MAR or lower
6. Fundus visualization is possible
7. Absence of retinal or optic nerve diseases
 
 
ExclusionCriteria 
Details  1. Previous intraocular or corneal surgery that may affect refraction accuracy or visual acuity
2. Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens
3. History or evidence of any ocular disease that may affect visual acuity
4. Rubella cataract
5. Amblyopia
6. Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the Intensity SL lens
7. Pupil abnormalities
8. Patients with pupil diameter greater than 4 mm in photopic conditions
9. Pregnant, lactating, or planning to become pregnant during the course of the trial
10. Allergy or intolerance to required study medications
11. Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
12. Traumatic cataract
13. Irregular astigmatism
14. Instability of keratometry or biometry measurements
15. Patients receiving chloroquine treatment
16. Patient having Microphthalmia
17. Patient having Chronic Uveitis
18. Patient suffering from Corneal dystrophy or endothelial insufficiency.
19. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma) 
 
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 
1. Uncorrected Distance Visual Acuity (UDVA) @ 6 m (20 Foot)
2. Uncorrected Intermediate Visual Acuity (UIVA) @ 66 cm
3. Uncorrected Near Visual Acuity (UNVA) @ 40 cm 		 Post-Operative: Month 1, Month 6 & Month 12 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction and quality of vision between the two IOLs, using McAlindens.
spherical aberration of intraocular lenses is measured using wavefront aberrometry. Visual performance by De-Focus curve. 		 Post-Operative: Month 1, Month 6 & Month 12 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   01/05/2026 
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="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 31-12-2027?
    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 compare the binocular visual acuity for far, intermediate and near distance AND, to measure the Defocus Curve, Contrast Sensitivity & patient satisfaction among patients undergoing binocular cataract with pentafocal or trifocal Intraocular Lenses implantation.

 
Close