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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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