| CTRI Number |
CTRI/2026/04/109369 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two methods of selecting lens power in patients undergoing cataract surgery to achieve better vision after surgery |
|
Scientific Title of Study
|
To compare the predictive accuracy of the Barrett Universal 2 and SRK/T intraocular lens power calculation formulae in patients undergoing uneventful phacoemulsification 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 Pawan Prasher |
| Designation |
Professor |
| Affiliation |
SRI GURU RAMDAS UNIVERSITY OF HEALTH SCIENCES, VALLAH,AMRITSAR |
| Address |
Department of ophthalmology, Sri guru ramdas institute of medical sciences, Amritsar
Department of ophthalmology, Sri guru ramdas institute of medical sciences, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9646104858 |
| Fax |
|
| Email |
pawanprasher@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Prasher |
| Designation |
Professor |
| Affiliation |
SRI GURU RAMDAS UNIVERSITY OF HEALTH SCIENCES, VALLAH,AMRITSAR |
| Address |
Department of ophthalmology, Sri guru ramdas institute of medical sciences, Amritsar
Department of ophthalmology, Sri guru ramdas institute of medical sciences, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9646104858 |
| Fax |
|
| Email |
pawanprasher@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parneet Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ramdas University Of Health Sciences |
| Address |
Department of ophthalmology, Sri Guru Ramdas Institute Of Medical Sciences, Amritsar
Department Of Ophthalmology, Sri Guru Ramdas Institute Of Medical Sciences, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
7837828490 |
| Fax |
|
| Email |
parneetk9819@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Ophthalmology, Sri Guru Ramdas Institute Of Medical Sciences And Research, Amritsar, 143001 , Punjab, India |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF OPHTHALMOLOGY, SGRDIMSR AMRITSAR |
| Address |
Sri Guru Ramdas Institute Of Medical Sciences And Research,Mehta Road, Post Office Vallah, Amritsar - 143501, Punjab, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Parneet Kaur |
Sri Guru Ramdas University Of Health Sciences, Vallah,Amritsar |
Department of ophthalmology, Sri Guru Ramdas University Of Health Sciences, Vallah,Amritsar
Amritsar
PUNJAB |
7837828490
parneetk9819@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Barrett Universal 2 formula |
Intraocular lens power calculation using Barrett Universal 2 formula in patients undergoing phacoemusification cataract surgery |
| Comparator Agent |
SRK/T |
Intraocular lens power calculation using SRK/T formula in patients undergoing phacoemulsification cataract surgery |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Presence of visually significant age related cataract
Willingness to give informed consent and comply with follow-up
Reliable and complete biometric measurements obtained using optical biometry
Patients having being given medical fitness with respect to ECG findings and RBS values |
|
| ExclusionCriteria |
| Details |
Corneal opacities or irregular astigmatism interfering with keratometry
History of ocular trauma, inflammations or surgery (including refractive procedures)
High myopes
Retinal pathologies
Pre existing amblyopia
Co-existing ocular pathology affecting visual outcome (eg macular degeneration, glaucoma with field loss, uveitis)
Systemic diseases affecting vision
Intraoperative complications
Patients with cataract of grade 4 and 5 with suboptimal results on AL scan for IOL power calculation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Barrett Universal 2 formula provides a better predictability of IOL power calculation and is less susceptible to the effect of the corneal shape, than the SRK/T formula. The Barrett Universal formula, instead of the SRK/T formula, may be clinically helpful for improving the refractive accuracy, especially in eyes with steep or flat corneas. |
The Barrett Universal II formula provides a better predictability of IOL power calculation and is less susceptible to the effect of the corneal shape, than the SRK/T formula. The Barrett Universal formula, instead of the SRK/T formula, may be clinically helpful for improving the refractive accuracy, especially in eyes with steep or flat corneas. This will be assessed by calculating the refractive error at day 40 post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Barrett Universal formula, instead of the SRK/T formula, may be clinically helpful for improving the refractive accuracy, especially in eyes with steep or flat corneas which will be assessed by calculating the refractive error at day 40 post operatively |
40 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/05/2026 |
| 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="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
|
This comparative study aims to compare the predictive accuracy of Barrett Universal II and SRK T intraocular lens power calculation formulas in patients undergoing uneventful phacoemulsification cataract surgery. A total of 100 patients will be randomized into two groups, with intraocular lens power calculated using either Barrett Universal II or SRK T. Postoperative refraction will be assessed on day 40 and prediction error will be calculated by comparing predicted refraction with actual postoperative refraction. The study will compare mean prediction error, mean absolute error, and the proportion of eyes achieving refractive outcomes within 0.50 diopter and 1.00 diopter. The influence of biometric parameters such as axial length and keratometry on formula accuracy will also be evaluated. The study aims to determine which formula provides better refractive predictability in routine cataract surgery. |