| CTRI Number |
CTRI/2025/10/096477 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two intraocular lens
For there stability using multimodal imaging |
|
Scientific Title of Study
|
Comparative Analysis of the Stability of Two Toric Intraocular Lenses Using Multimodal Imaging |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atif Irfan |
| Designation |
Junior resident |
| Affiliation |
PGI chandigarh |
| Address |
Advance eye centre ,PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8210384008 |
| Fax |
|
| Email |
atifirfan786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anchal Thakur |
| Designation |
Associate professor |
| Affiliation |
PGI chandigarh |
| Address |
Advance eye center ,PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
85578 22773 |
| Fax |
|
| Email |
thakur_anchal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Atif Irfan |
| Designation |
Junior resident |
| Affiliation |
PGI chandigarh |
| Address |
ADVANCE EYE CENTER ,PGIMER(Postgraduate Institute of Medical Education and Research.)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8210384008 |
| Fax |
|
| Email |
atifirfan786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advance eye center
Postgraduate Institute of Medical Education and Research.
Chandigarh
India
160012 |
|
|
Primary Sponsor
|
| Name |
PGI chandigarh |
| Address |
Advance eye center ,pgi Chandigarh
160012 |
| Type of Sponsor |
Government 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 |
| Dr Atif irfan |
PGIMER(Postgraduate Institute of Medical Education and Research) |
Advance eye center ,department of ophthalmology ,lens clinic ,PGIMER
Sector 12
160012
Chandigarh
CHANDIGARH |
8210384008
atifirfan786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post graduate institute of medical education and research Chandigarh institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Type A ( L haptic ) |
Type A (L haptic) Toric Intraocular Lens a single piece aspheric hydrophobic acrylic IOL with an L shaped haptic design, implanted in the bag during standard phacoemulsification.duration of 1 year til September 2026 |
| Comparator Agent |
Type B (C-loop) Toric Intraocular Lens |
Type B (C-loop) Toric Intraocular Lens — a single-piece, aspheric, hydrophobic acrylic IOL with a C-loop haptic design, implanted under identical surgical conditions.Duration till Sept 2026 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Presence of cataract with regular corneal astigmatism requiring Toric IOL
implantation
3. Axial length ranging between 22 mm and 25 mm
4. Against-the-rule ATR astigmatism 0.75 D or with-the-rule WTR astigmatism
More than 1.00 D Preoperatively
5. Willingness and ability to comply with postoperative follow-up for a minimum period
of 6 months
6. Rhexis size 5-5.5 mm measured intraoperatively using verion guided system. |
|
| ExclusionCriteria |
| Details |
History of prior ocular surgery
2. History of ocular trauma
3. Rhexis size 5 mm and 5.5mm.
4. Corneal conditions that could adversely affect visual outcomes, such as scarring or
endothelial dysfunction
5. Presence of irregular or decentered pupils
6. Clinically significant zonular weakness
7. Diagnosed glaucomatous optic neuropathy
8. History of uveitis or preexisting retinal pathologies
9. Refusal to randomization or unwillingness to procure assigned lens prior to surgery |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the rotational stability of toric intraocular lenses (IOLs) in pseudophakic eyes over a 6-
month follow-up period and assess their impact on visual function |
1 month ,3 month ,6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the positional stability of Toric intraocular lenses over a 6 month follow - up period and
assess their impact on visual function. This will be achieved by analyzing the following parameter
17
• IOL decentration (iTrace)
• IOL tilt (AS-OCT)
• Anterior chamber depth (IOL Master & AS-OCT)
• Visual acuity (UCVA & BCVA)
• Higher-order aberrations (iTrace)
• Strehl ratio (iTrace)
2)To compare the two toric IOL designs included in the study—differing in haptic design and
material—based on the above measurements. The objective is to determine whether one lens design
demonstrates superior in vivo stability or results in better visual & optical outcomes across the
postoperative period. |
1 week, 1 month, 3 month , 6 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/11/2025 |
| 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
|
This study focuses on assessing the positional stability of toric intraocular lenses (IOLs) implanted during cataract surgery for correction of corneal astigmatism. The success of a toric IOL depends on its rotational and axial stability within the capsular bag—any rotation, tilt, or decentration can significantly reduce the astigmatic correction and degrade visual quality.
The research compares two types of toric IOLs with different haptic designs—Type A (L-haptic) and Type B (C-loop)—to evaluate their stability using multimodal imaging techniques. These include Anterior Segment Optical Coherence Tomography (AS-OCT) for measuring IOL tilt, decentration, and anterior chamber depth, and iTrace aberrometry for assessing IOL rotation, higher-order aberrations (HOAs), and visual quality indices such as the Strehl ratio.
This is a prospective randomized controlled trial, with patients stratified based on corneal toricity (low vs high). Following phacoemulsification and toric IOL implantation, postoperative assessments are done at 1 month, 3 months, and 6 months, focusing primarily on rotational stability and secondarily on optical alignment, image quality, and visual acuity outcomes.
The findings are expected to help determine which haptic design provides superior postoperative stability, leading to more predictable refractive results, improved patient satisfaction, and enhanced guidelines for IOL selection in routine cataract surgery.
|