FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/107365 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 27/03/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Quality of vision in patients receiving new Monofocal Intraocular Lens to achieve Enhanced Intermediate Vision with Astigmatism Correction after cataract surgery 
Scientific Title of Study   A Prospective single arm clinical study to assess the clinical outcomes and patient satisfaction of a pre-loaded Swiss Phob Toric Hydrophobic intraocular lens in patients undergoing bilateral cataract surgery. 
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

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  Dr. Agarwals Eye Hospital, No.15, South Bypass Road, Vannarpettai Tirunelveli
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  
Dr. Agarwals Eye Hospital No.15, South Bypass Road, Vannarpettai Tirunelveli 627003 
 
Primary Sponsor  
Name  Prof D Lional Raj 
Address  Dr. Agarwals Eye Hospital, No.15, South Bypass Road, Vannarpettai Tirunelveli 627003 
Type of Sponsor  Other [SELF] 
 
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 
Dr Lional Raj D  Dr. Agarwals Eye Hospital  Dept. of Cataract & IOL, No.15, South Bypass Road, Vannarpettai 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 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Swiss Phob Toric Hydrophobic IOLs (Pre-loaded)  UV and Blue light filtering Yellow Chromophore Hydrophobic acrylic IOL with square edge design. OPTIC CHARACTERISTICS: Optic Diameter: 6.00mm Optic Shape: Biconvex Optic Design: Anterior Higher order aspheric surface with posterior toricity. Asphericity: Negative aspheric design. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms;
2. Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation as estimated by potential acuity meter (PAM) or surgeon estimation Have corneal thickness more than600 µm by OCT
3. Less than or equal to 1.0 D of preoperative keratometric astigmatism
4. Clear intraocular media other than cataract
5. Given written informed consent by subject.
6. Subjects are willing and able to comply with schedule for follow up visits
7. Subjects should be 22 years or older
 
 
ExclusionCriteria 
Details  1. Systemic disease that could increase the operative risk or confound the outcome;
2. Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator [tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)];
3. Ocular condition that may predispose for future complications
4. Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject
5. Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes;
6. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse
7. Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens;
8. If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Best Corrected distance visual acuity (BCDVA) @ 6 m (20 Foot)
2. Distance Corrected Intermediate visual acuity (DCIVA) @ 66 cm
3.Corrected Near Visual Acuity (CNVA) @ 40 cm
 		 BCDVA: Preoperative and Post-Operative: Day 1, Week 1, Month 1,3 & 12.
DCIVA & CNVA - Post-Operative: Month 1,3 & 12. 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction and quality of vision, using McAlindens & subjective feed back questionnaire.
Anterior Capsule Contraction Syndrome. 		 Post-Operative: Month 1, Month 3 & Month 12  
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   21/04/2026 
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-identification.

  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 31-05-2028 and end date provided 30-12-2028?
    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 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 Advanced Monofocal Aspheric intraocular lens implantation.

 
Close