| CTRI Number |
CTRI/2025/09/094854 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Choosing the right Intraocularlens after Cataract surgery : Multifocal vs Monofocal |
|
Scientific Title of Study
|
Visual Outcome with Multifocal vs Monofocal IOLs after Phacoemulsification |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrOjasvi Mehta |
| Designation |
Post graduate student ,Department of Ophthalmology ESIC, MCH Faridabad |
| Affiliation |
ESIC,Medical college and Hospital , Faridabad, 121001 |
| Address |
Department of Ophthalmology , Eye OPD 2nd Floor, Room no.1 ESIC, Medical college and Hospital ,Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
8053953830 |
| Fax |
|
| Email |
mehta.ojasvi099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Rastogi |
| Designation |
Professor and Head , Department of Ophthalmology |
| Affiliation |
ESIC,Medical college and Hospital , Faridabad, 121001 |
| Address |
Department of Ophthalmology ,Eye OPD, 2nd floor, Room NO.8 ,ESIC,Medical college and Hospital ,Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
09818340924 |
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Rastogi |
| Designation |
Professor and Head , Department of Ophthalmology |
| Affiliation |
ESIC,Medical college and Hospital , Faridabad, 121001 |
| Address |
Department of Ophthalmology ,2nd floor ,Eye OPD ,ROOM NO. 8 ESIC,Medical college and Hospital ,Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
09818340924 |
| Fax |
|
| Email |
dranjurastogi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and hospital, NIT 3,Faridabad,121001,Haryana,India |
|
|
Primary Sponsor
|
| Name |
Dr.Ojasvi Mehta |
| Address |
ESIC Medical College and Hospital NIT-5 ,Faridabad,121001 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ojasvi Mehta |
ESIC Medical college and Hospital ,Faridabad 121001, haryana |
Department of Ophthalmology, 2nd floor, Eye OPD Room no.1 ESIC MCH, New Industrial Township 3,Faridabad,121001,Haryana, India
Faridabad
HARYANA |
8053953830
mehta.ojasvi099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ESIC Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Monofocal IOL |
30 eyes undergoing Phacoemulsification(20-25 minutes) with Monofocal IOL implantation . |
| Intervention |
Multifocal IOL |
30 eyes undergoing Phacoemulsification (20-25 minutes) with multifocal IOL implantation. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Visually significant senile cataract.
2. Age more than equal to 50 years.
3. Regular corneal astigmatism of less than equal to 1.0D |
|
| ExclusionCriteria |
| Details |
1. Active ocular infection (keratitis, conjunctivitis, episcleritis, scleritis)
2. Previous ocular inflammation (uveitis, choroiditis, retinitis)
3. History of ocular trauma.
4. History of contact lens use.
5. Corneal disease or dystrophies
6. Pterygium
7. Glaucoma
8. Posterior segment abnormalities (diabetic or hypertensive retinopathy, macular pathology).
9. History of long-term use of ophthalmic medication or drugs affecting tear film . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and assess the uncorrected visual acuity and best corrected visual acuity in patients undergoing Phacoemulsification with multifocal IOL vs monofocal IOL.
|
At Day1, Week1 ,Week4 , Week6 .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare and assess the contrast sensitivity in patients undergoing Phacoemulsification with multifocal IOL vs monofocal IOL.
2.To compare the adverse effects like glare and haloes in patients undergoing Phacoemulsification with multifocal IOL vs monofocal IOL . |
Contrast Sensitivity at Week4,Week6.
Glare/haloes at Week1 ,Week 4,Week6 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Title of study Visual outcome with multifocal vs monofocal IOLs after Phacoemulsification. Patients to be included 1. Visually significant senile cataract. 2. Age more than equal to 50 years. 3. Regular corneal astigmatism of less than equal to1.0D Patients to be excluded 1. Active ocular infection (keratitis, conjunctivitis, episcleritis, scleritis) 2. Previous ocular inflammation (uveitis, choroiditis, retinitis) 3. History of ocular trauma. 4. History of contact lens use. 5. Corneal disease or dystrophies 6. Pterygium 7. Glaucoma 8.Posterior segment abnormalities (diabetic or hypertensive retinopathy, macular pathology) 9. History of long-term use of ophthalmic medication or drugs affecting tear film . Sample size is 30 in Each group Assessment To compare the visual outcome in terms of uncorrected visual acuity, best corrected visual acuity, contrast sensitivity and to compare the adverse effects like glare and haloes in patients undergoing Phacoemulsification with multifocal IOL vs monofocal IOl . Analysis Data will be analysed and appropriate statistical tests will be used to compile the results. |