| CTRI Number |
CTRI/2026/01/101507 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative outcomes of toric intraocular lens implantation using using two guiding platforms: a prospective randomized controlled trial |
|
Scientific Title of Study
|
Comparative outcomes of toric intraocular lens (IOL) implantation using ALLY-guided workflow versus ZEISS CALLISTO eye markerless guidance in phacoemulsification cataract surgery: a prospective randomized controlled trial |
| 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 Sanjay Kumar Mishra |
| Designation |
Consultant and HOD Ophthalmology |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Room No 1 Dept of Ophthalmology Army Hospital Research and Referral Dhaulakuan New Delhi
South West DELHI 110010 India |
| Phone |
9811551327 |
| Fax |
|
| Email |
mishsanjay@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srujana Dubbaka |
| Designation |
Senior Advisor Ophthalmology |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Room No 17 Dept of Ophthalmology Army Hospital Research and Referral Dhaulakuan New Delhi
South West DELHI 110010 India |
| Phone |
9958748575 |
| Fax |
|
| Email |
drsrujanabhaskar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Srujana Dubbaka |
| Designation |
Senior Advisor Ophthalmology |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Room No 17 Dept of Ophthalmology Army Hospital Research and Referral Dhaulakuan New Delhi
South West DELHI 110010 India |
| Phone |
9958748575 |
| Fax |
|
| Email |
drsrujanabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of Director General Armed Forces Medical Services |
|
|
Primary Sponsor
|
| Name |
Ministry of Defence |
| Address |
Ministry of Defence
401 A Block Defence Offices Complex
Africa Avenue New Delhi 110023
|
| 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 Srujana Dubbaka |
Arrmy Hospital Research and Referral |
Room No 17 Dept of Ophthalmology Army Hospital Research and Referral Dhaulakuan New Delhi South West DELHI |
09958748575
drsrujanabhaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AHRR |
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 |
Ally Group |
Use the ALLY workflow for cataract surgery as per manufacturer for guidance overlays.For femtosecond capsulotomy, standardize capsulotomy diameter and centration strategy for fragmentation. Utilize the on screen astigmatic axis guidance and the knubs given on the capsulorrhexis margins for toric alignment. |
| Comparator Agent |
Callisto group |
Use ZEISS CALLISTO eye markerless overlays linked to IOLMaster reference image for cataract surgery. Ensure correct data transfer and registration. Align toric axis using on screen guidance |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Regular corneal astigmatism more than 1.00D (K readings compatible with toric IOL range)
Clear corneal media for accurate imaging and aberrometry |
|
| ExclusionCriteria |
| Details |
Irregular astigmatism (topographic evidence), keratoconus or ectasia suspects.
Prior corneal or refractive surgery
Zonulopathy, pseudoexfoliation with significant instability, traumatic cataract.
Corneal opacity, pterygium , severe dry eye
Uveitis, uncontrolled glaucoma, macular pathology limiting VA , optic neuropathy.
Intraoperative complications precluding planned IOL implantation or axis alignment.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of eyes with residual cylinder more than 0.50 D and less than 1.00 D |
At three months post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean absolute residual refractive cylinder manifest refraction |
at 3 months post op |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
28/01/2026 |
| 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 Applicable |
| 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
|
Precise
alignment of toric intraocular lenses is critical for effective correction of
corneal astigmatism during cataract surgery, as each degree of postoperative
misalignment can reduce astigmatic correction by approximately 3.3percent. This
prospective, randomized controlled trial compares the clinical outcomes of
toric IOL implantation using two advanced intraoperative guidance systems: the
ALLY femtosecond-assisted workflow and the ZEISS CALLISTO eye markerless
guidance. The study aims to evaluate refractive accuracy, rotational stability,
surgical efficiency, and patient-reported outcomes following
phacoemulsification cataract surgery.
Eligible
participants are adults with regular corneal astigmatism more than 1.00 D and
visually significant cataracts. Subjects are randomized to receive toric IOL
alignment via either ALLY or CALLISTO guidance, with standardized preoperative
planning, surgical technique, and postoperative care across both arms. The
primary endpoint is proportion of eyes within
0.50 D and 1.00 D of refractive targets, mean absolute residual refractive
cylinder at 3 months postoperatively. Secondary endpoints include IOL
rotational stability, uncorrected and corrected distance visual acuity, vector
analysis of astigmatism (Alpins method), intraoperative metrics, need for IOL
repositioning, patient-reported visual quality, and safety outcomes. Outcome
assessors are masked to group allocation, and analyses will be conducted on an
intention to treat basis with per protocol sensitivity.
This trial will provide high-quality evidence to inform best
practices in toric IOL alignment and may influence future adoption of
integrated femtosecond platforms versus markerless image guided systems in
cataract surgery |