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CTRI Number  CTRI/2017/01/007724 [Registered on: 19/01/2017] Trial Registered Prospectively
Last Modified On: 13/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   LASIK vs SMILE 
Scientific Title of Study   Comparison of Topography Guided LASIK with WaveLight EX500 to SMILE with Zeiss VisuMax 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RFL605-P001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Shetty 
Designation  Vice chairman and Clinical & Translational scientist  
Affiliation  Narayana Nethralaya 
Address  Room no:104, first floor, Cornea and refractive service department, Narayana Nethralaya, 121/C, Chord Road, Rajaji Nagar Bangalore-560010 Bangalore KARNATAKA

Bangalore
KARNATAKA
560010
India 
Phone    
Fax    
Email  drrohitshetty@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Salman Anzer 
Designation  Head, Medical Affairs 
Affiliation  Alcon Laboratories Pvt Ltd (India) 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield Bangalore Bangalore KARNATAKA 560048 India

Bangalore
KARNATAKA
560048
India 
Phone  08040064683  
Fax    
Email  salman.anzer@alcon.com  
 
Details of Contact Person
Public Query  
Name  Dr Salman Anzer 
Designation  Head, Medical Affairs 
Affiliation  Alcon Laboratories Pvt Ltd (India) 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield Bangalore Bangalore KARNATAKA 560048 India

Bangalore
KARNATAKA
560048
India 
Phone  08040064683  
Fax    
Email  salman.anzer@alcon.com  
 
Source of Monetary or Material Support  
Alcon laboratories India pvt Ltd 
 
Primary Sponsor  
Name  Alcon laboratories India pvt Ltd 
Address  Crescent 4, 3rd floor ,Prestige Shantiniketan , Bangalore 560048 Karnataka 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Brazil
India
Mexico
Singapore
Other  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAMAMURTHY DHANDAPANI  The Eye Foundation  Ground Floor, cataract and refractive services, 582 A, Dewan Bhadur Road, R.S. Puram, Coimbatore, Tamilnadu, 641002, IN
Coimbatore
TAMIL NADU 		 9443317791

drramamurthy@theeyefoundation.com 
DR ROHIT SHETTY  NARAYANA NETHRALAYA (NN1)  Room no 104 first floor, cornea and refractive service department, 121/C Chord road, 1 R Block Rajaji Nagar, 3rd Floor, Banaglore, 560010, IN
Bangalore
KARNATAKA 		 8066121415

drrohitshetty@yahoo.com 
DR JEEWAN TITIYAL  RP Center for Ophthalmic Science  Room No: 491 Floor No:04, Professor and Head of the department, Cornea cataract and refractive surgery services, Sri Aurobindo Marg, Ansari Nagar, New Delhi, Delhi, 110029, IN
North
DELHI 		 9810649942

titiyal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Insitutional Ethics Committee  Submittted/Under Review 
Institute Ethics committee of All India Institute of Medical Sciences  Submittted/Under Review 
Narayana Nethralaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Myopia and Astigmatism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  The Zeiss VisuMax laser keratome ophthalmic surgical laser  Small incision lenticular extraction (SMILE) is the newest refractive surgery procedure 
Intervention  WaveLight® EX500 excimer laser system  Laser in situ keratomileusis (LASIK), a refractive surgery procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Inclusion criteria: Ocular criteria must be met in both eyes.
1. Subjects 18 years of age or older.
2. Able to comprehend and sign an informed consent form (ICF).
3. Willing and able to complete all post-surgery visits.
4. Myopia requiring (a) refractive error correction of -0.5 to -8.0 D manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism. 
 
ExclusionCriteria 
Details  1. Pregnancy or lactation, current or planned, during the course of the study.
2. Manifest refraction astigmatism that is more than 1.00 D than the topolyzer astigmatism assessed by Topolyzer Vario.
3. Mixed astigmatism refractive error.
4. Degenerations of structure of the cornea including diagnosed keratoconus, forme fruste kerataconus or pellucid marginal degeneration.
5. Dry eye as identified by the short questionnaire for dry eye syndrome (SQDES).
6. A calculated residual stromal bed thickness that is less than 250 μm.
7. History or evidence of active or inactive corneal or other anterior segment disease (e.g, herpes simplex keratitis, recurrent erosion
syndrome).
8. Diagnosed advanced glaucoma.
9. Uncontrolled diabetes.
10. Nystagmus or any other condition that would prevent a steady gaze during the treatment.
11. Previous intraocular or corneal surgery.
12. Weakened immune system, including diagnosed collagen vascular, autoimmune or immunodeficiency disease.
13. Systemic medications that may affect corneal healing including,but not limited to steroids, antimetabolites, immune response modifying drugs, etc.
14. Presence or history of any condition or finding that makes the subject unsuitable as a candidate for refractive surgery or study
participation or may confound the outcome of the study, in the opinion of the Investigator.
15. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
16. A known sensitivity to medications used during the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Percentage of eyes with manifest refraction cylinder ≤ 0.5 D at 3 months  on the day of the surgery (i.e. Visit 00)  
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean manifest refraction cylinder at 3 months.
2. Mean UCVA at 3 months 		 on the day of the surgery (i.e. Visit 00)  
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="150" 
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)   31/01/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The Purpose of this study to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticlule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism. 
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