| CTRI Number |
CTRI/2026/01/100383 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ARCUATE CORNEAL INCISIONS VERSUS TORIC INTRAOCULAR LENS IMPLANTATION IN FEMTOSECOND LASER ASSISTED CATARACT SURGERY FOR LOW TO MODERATE CORNEAL ASTIGMATISM: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL |
|
Scientific Title of Study
|
ARCUATE KERATOTOMY VERSUS TORIC INTRAOCULAR LENS IMPLANTATION IN FEMTOSECOND LASER ASSISTED CATARACT SURGERY FOR LOW TO MODERATE CORNEAL ASTIGMATISM: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
Arcuate Keratotomy vs TORIC IOL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dubbaka Srujana |
| Designation |
Professor Ophthalmology |
| Affiliation |
Army Hospital (Research and Referral) |
| Address |
Dept of Ophthalmology Army Hospital (Research and Referral) Dhaulakuan New Delhi
South West
DELHI
110010
India |
| Phone |
09958748575 |
| Fax |
|
| Email |
drsrujanabhaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dubbaka Srujana |
| Designation |
Professor Ophthalmology |
| Affiliation |
Army Hospital (Research and Referral) |
| Address |
Dept of Ophthalmology Army Hospital (Research and Referral) Dhaulakuan New Delhi
South West
DELHI
110010
India |
| Phone |
09958748575 |
| Fax |
|
| Email |
drsrujanabhaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dubbaka Srujana |
| Designation |
Professor Ophthalmology |
| Affiliation |
Army Hospital (Research and Referral) |
| Address |
Dept of Ophthalmology Army Hospital (Research and Referral) Dhaulakuan New Delhi
South West
DELHI
110010
India |
| Phone |
09958748575 |
| Fax |
|
| Email |
drsrujanabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Oo DGAFMS Ministry of Defence A Block Defence Offices Complex Africa Avenue New Delhi |
| Address |
Army Hospital (Research and Referral)) |
| 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 Dubbaka Srujana |
Army Hospital (Research & Referral)) |
Cabin 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 Army Hospital (R&R) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femtosecond-assisted arcuate keratotomy (FSAK) |
Patients with cataract will undergo femtosecond-assisted arcuate keratotomy with monofocal IOL implantation using ALLY platform |
| Comparator Agent |
Toric Intraocular Lens |
Patients with cataract will undergo toric IOL implantation with femtosecond-assisted cataract surgery using ALLY platform |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Presence of visually significant cataract
Pre-existing regular corneal astigmatism (1.0 D to 2.0 D)
Clear corneal media
|
|
| ExclusionCriteria |
| Details |
Irregular astigmatism
Corneal pathology (scar, keratoconus, dystrophy)
Previous ocular surgery or trauma
Posterior segment pathology affecting vision
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Residual refractive astigmatism |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| UDVA, BCVA, Rotational stability (TIOL group), patient satisfaction |
3 months |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/01/2026 |
| 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="0"
Months="6"
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
|
Both femtosecond laser arcuate keratotomy
(FSAK) and toric intraocular lenses (TIOLs) are established techniques to
correct corneal astigmatism during cataract surgery. With the advent of the
ALLY Adaptive Cataract Treatment System, the precision and integration of FSAK
have improved. This randomized controlled trial evaluates FSAK versus TIOLs for
astigmatism correction. It is a prospective,
assessor-masked, randomized controlled trial at a tertiary care centre over 06
months. Patients with regular corneal astigmatism (1.0–2.0 D) and visually
significant cataract will be randomized to either FSAK and monofocal IOL using
ALLY, or TIOL implantation using ALLY.
Primary endpoint is residual refractive cylinder at 3 months. Secondary
outcomes are uncorrected and bestcorrected distance visual acuity, vector
analysis, rotational stability (TIOL), patient satisfaction, and adverse
events.This trial will clarify whether ALLY assisted FSAK can achieve
refractive outcomes comparable to TIOL implantation with potential workflow
advantages. |