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CTRI Number  CTRI/2025/03/083024 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   UV-Femtosecond Laser Assisted Lenticule Extraction Study 
Scientific Title of Study   UV-Femtosecond Laser Assisted Lenticule Extraction Astigmatism Nomogram Study in Subjects With Myopia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RFO268-C004 V2.0 15Dec2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Shetty 
Designation  Cornea & Refractive Surgeon Clinical Scientist 
Affiliation  Narayana Nethralaya 
Address  Narayana Nethralaya 01 121 C Chord Road Near Iskcon Temple 1st R Block Rajajinagar Bengaluru Bangalore KARNATAKA 560010 India

Bangalore
KARNATAKA
560010
India 
Phone    
Fax    
Email  drrohitshetty@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Pavan Kumar 
Designation  Sr Associate II, Clinical Trial Operations  
Affiliation  Alcon laboratories India Pvt Ltd 
Address  R11 Floor A wing Cabin 047 Clinical Research and development department Godrej Woodsman Estate RMZ Azure It Complex 9th 10th and 11th Bellary Rd Hebbal Bengaluru Bangalore KARNATAKA 560092 India
Alcon Laboratories
Bangalore
KARNATAKA
560092
India 
Phone  9963170098  
Fax    
Email  pavan-1.kumar@alcon.com  
 
Details of Contact Person
Public Query  
Name  Pavan Kumar 
Designation  Sr Associate II, Clinical Trial Operations  
Affiliation  Alcon laboratories India Pvt Ltd 
Address  R11 Floor A wing Cabin 047 Clinical Research and development department Godrej Woodsman Estate RMZ Azure It Complex 9th 10th and 11th Bellary Rd Hebbal Bengaluru Bangalore KARNATAKA 560092 India
Alcon Laboratories
Bangalore
KARNATAKA
560092
India 
Phone  9963170098  
Fax    
Email  pavan-1.kumar@alcon.com  
 
Source of Monetary or Material Support  
Alcon Laboratories Inc 6201 South Freeway Fort Worth, TX 76134-2099 USA 
 
Primary Sponsor  
Name  Alcon Laboratories Inc 
Address  6201 South Freeway Fort Worth, TX 76134-2099 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Alcon Laboratories Pvt Ltd  Alcon Laboratories (India) Private Limited 11th Floor RMZ Azure Bellary Road Hebbal Bengaluru Bengaluru India 560092 
 
Countries of Recruitment     Greece
Australia
Germany
India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit Shetty  Narayana Nethralaya 01  Narayana Nethralaya 01, B Block, 1st Floor, Room No. 106 121 C Chord Road, Near Iskcon Temple, 1st R Block, Rajajinagar Bengaluru Bangalore KARNATAKA 560010 India Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9632419350

drrohitshetty@yahoo.com 
Dr Rohit Shetty  Narayana Nethralaya 02  Narayana Health City Narayana Hrudayalaya Campus 258/A Bommasandra Hosur Rd Electronic City Bengaluru Bangalore Urban Karnataka 560099
Bangalore
KARNATAKA 		 9632419350

drrohitshetty@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Narayana Nethralaya Ethics Committee  Approved 
Narayana Nethralaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H522||Astigmatism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  WaveLight Ultraviolet Femtosecond Laser System Model 1026 UV fs Laser with accompanying Patient Interface Model 1507  Preparation of the subject for surgery involves the use of a patient interface which is investigational. The subject could be exposed to the patient interface on 2 occasions if surgery needs to be rescheduled due to inadequate docking on the first occasion. The amount of time of exposure to the patient interface may vary but is approximately 2 to3 minutes at most The duration of the laser suction on the prior study varied from 35 seconds to 100 seconds so a total time of exposure to interface and laser is approximately 3 to 4 minutes when the surgery is completed in one visit. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Myopia with sphere of -0.50 to -10.0 diopter and cylinder -0.25 to -2.0 diopter in study eye.

Stable refraction in the study eye.

Nondominant eye must qualify for treatment.

BCDVA better or Equal 0.14 logMAR in study and fellow eyes

UCDVA Worse or equal 0.30 logMAR in study eye
Presence of clear natural lens (non-cataractous eye) in study eye.

Minimum required endothelial cell density in study eye within defined age
ranges. 
 
ExclusionCriteria 
Details  Study eye unable to focus for imaging and or treatment.

Acute or chronic disease or illness that would increase the operative risk or
confound the outcomes of the study.

Current use of medications with known ocular side effects and
photosensitivity.

Ocular conditions in the either eye that may affect subject safety or impact
study outcomes.

Previous ocular surgery in the study eye that resulted in corneal distortions
within the treatment zone 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Astigmatism subjective (manifest dry) manifest refraction at postoperative follow-up visits
[Time Frame: Week 1, Month 1, Month 3, Month 6]
2. Best Corrected Distance Visual Acuity (BCDVA) at postoperative follow-up visits
[Time Frame: Week 1, Month 1, Month 3, Month 6]
3. Ocular Serious Adverse Events 		 1. Week 1, Month 1, Month 3, Month 06
2. Week 1, Month 1, Month 3, Month 06
3. From time of consent to study exit (cumulative to Month 6 postoperative)  
 
Secondary Outcome  
Outcome  TimePoints 
1. Spherical subjective (manifest dry) refraction at postoperative follow-up visits
2. Uncorrected Distance Visual Acuity at all postoperative follow-up visits
3. Manifest Refraction Spherical Equivalent (MRSE) at postoperative follow-up visits
 		 1. Week 1, Month 1, Month 3, Month 06
2. Day 1, Week 1, Month 1, Month 3, Month 6
3. Week 1, Month 1, Month 3, Month 6
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/03/2025 
Date of Study Completion (India) 13/02/2026 
Date of First Enrollment (Global)  08/11/2024 
Date of Study Completion (Global) 13/02/2026 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  
The purpose of this study is to obtain additional safety and effectiveness data on the WaveLight® Ultraviolet Femtosecond Laser System (UV fs-Laser) lenticule extraction procedure to assess the accuracy and assist in developing of the astigmatism nomogram across a defined dioptric range.
The treatment range is -0.5 to -10.0 diopters (D) spherical component and -0.25 to -2.0 D cylinder component of the manifest refraction. Subjects will undergo lenticule extraction treatment in the study eye and, if needed, a suitable approved refractive therapy in the fellow eye. Subjects will be expected to attend at least 7 scheduled study visits: A screening visit, a surgery visit, and 5 post-operative visits (Day 1, Week 1, Month 1, Month 3, Month 6) for an individual total duration of participation of approximately 7 months.
 
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