| 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 |
|
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Details of Secondary Sponsor
|
|
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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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
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Intervention / Comparator Agent
|
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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
|
|
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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
|
|
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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 ® 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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