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CTRI Number  CTRI/2022/06/043199 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Visual performance of a new intra ocular lens 
Scientific Title of Study   Evaluation of the visual performance of Clareon intraocular lens after bilateral implantation in patients targeted for mini-monovision - A prospective, single center, longitudinal study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suhas Haldipurkar 
Designation  Medical Director 
Affiliation  Laxmi Eye Institute and Laxmi Charitable Trust 
Address  Laxmi Eye Institute and Laxmi Charitable Trust Hamid Mulla Road Panvel
Hamid Mulla Road Panvel 410206
Raigarh
MAHARASHTRA
410206
India 
Phone  02227452228  
Fax    
Email  info@laxmieye.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suhas Haldipurkar 
Designation  Medical Director 
Affiliation  Laxmi Eye Institute and Laxmi Charitable Trust 
Address  Laxmi Eye Institute and Laxmi Charitable Trust Hamid Mulla Road Panvel
Hamid Mulla Road Panvel 410206
Raigarh
MAHARASHTRA
410206
India 
Phone  02227452228  
Fax    
Email  info@laxmieye.org  
 
Details of Contact Person
Public Query
 
Name  Dr Suhas Haldipurkar 
Designation  Medical Director 
Affiliation  Laxmi Eye Institute and Laxmi Charitable Trust 
Address  Laxmi Eye Institute and Laxmi Charitable Trust Hamid Mulla Road Panvel
Hamid Mulla Road Panvel 410206
Raigarh
MAHARASHTRA
410206
India 
Phone  02227452228  
Fax    
Email  info@laxmieye.org  
 
Source of Monetary or Material Support  
Alcon Laboratories India Pvt Ltd 
 
Primary Sponsor  
Name  Alcon Laboratories India Pvt Ltd 
Address  11th Floor RMZ Azure Bellary Road Hebbal Bengaluru Pin 560092 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Tanvi Haldipurkar  Laxmi Eye Institute and Laxmi Charitable Trust  Room No - G5, Department of Cataract and Refractive Surgery, Main Building, Laxmi Eye Institute, Hamid Mulla Road, Panvel -410206
Raigarh
MAHARASHTRA 
02227452228

mdoffice@laxmieye.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Laxmi Eye Institute Ethics Committee  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who have been implanted bilaterally with Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC)
Uncomplicated age related cataract who underwent uncomplicated bilateral cataract surgery by phacoemulsification technique
Preoperative & postoperative corneal astigmatism of ≤ 0.75 D
Willing to provide consent for follow-up
Completed all the study follow-up as per the protocol
 
 
ExclusionCriteria 
Details  Subjects with prior history of any intraocular surgery
Subject who underwent any additional procedures during cataract surgery
Subjects who underwent complicated cataract surgery
Subjects who had any post-operative complications
Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism)
Post op manifest refraction(Spherical Equivalent) > +/-0.25 D in the dominant eye and < -0.5 D or >-0.75 D in the non-dominant eye
Subject who is not willing to sign Informed Consent Form for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Acuity: Snellen’s visual acuity charts will be used for distance and Notation (N) charts were used for intermediate (66 centimetres) and near (40 centimetres) visual acuity.  Screening
Day 1 assessment
Day 15 assessment
Day 30 assessment
Day 90 Assessment
 
 
Secondary Outcome  
Outcome  TimePoints 
Contrast sensitivity
High Order aberrations
Defocus Curve
Reading Parameters
Stereopsis
Quality of life
Photic phenomena
Fundus visualization  
Screening
Day 1 assessment
Day 15 assessment
Day 30 assessment
Day 90 Assessment
 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2022 
Date of Study Completion (India) 18/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Haldipurkar TS, Haldipurkar S, Venkatramani D, Walavalkar R, Deshpande S, Setia MS. Evaluation of Intermediate Visual Outcomes in Eyes Implanted with Bilateral Advanced Monofocal Intraocular Lens Targeting for Mini-Monovision and Its Association with Age and Corneal Asphericity. Clin Ophthalmol. 2024;18:2929-2937 https://doi.org/10.2147/OPTH.S484030 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Purpose: To assess the visual outcomes in patients bilaterally implanted with novel Clareon® intraocular lens when targeting mini monovision post-operatively.
Setting: The study was conducted at Laxmi Eye Institute; it is a tertiary care eye institution in Panvel, India.
Design: This is an investigator initiated, prospective, single-centre longitudinal study of 45 patients to assess the visual outcomes in patients who were implanted with Clareon Â® IOL bilaterally.
Methods: Patients with corneal astigmatism of ≤ 0.75 D who underwent bilateral cataract surgery with pseudophakic mini-monovision and implanted with novel Clareon® intraocular lens were included. Patients having post op manifest refraction >± 0.25 D in the dominant eye and <− 0.5 D or >− 0.75 D in the non-dominant eye were excluded. The main study outcomes were assessed at 1 and 3 months; it included uncorrected visual acuities assessment, defocus curve, and patient reported spectacle use.
Results: The mean (SD) binocular distance corrected intermediate visual acuity at 3 months was 0.22 (0.09) LogMAR. At 3 months, 54% of patients enjoyed 0.4 LogMAR or better BUCNVA. The defocus curve showed good distance and intermediate visual acuity with > 0.2 LogMAR vision from +0.50 D to − 1.50 D. We found a positive correlation between the Q value of the dominant eye and the BCIVA at 3 months postoperatively, however it was not statistically significant. The Q value was more negative when the intermediate vision was closer to 0 LogMAR. Post operatively, at  3 months,  95% patients did not need glasses for distance and intermediate vision and 73% of patients were comfortable for intermediate vision without glasses all the time.
Conclusion: Mini-monovision with Clareon® monofocal IOL implantation can offer overall satisfactory vision for far and intermediate distances with minimal need for use of spectacles for near vision.

 
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