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CTRI Number  CTRI/2021/04/033281 [Registered on: 30/04/2021] Trial Registered Prospectively
Last Modified On: 05/10/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Post-market clinical follow up study on SMILE treatment of short sightedness with or without cylinder 
Scientific Title of Study   Post-Market Clinical Follow-up Study on SMILE Treatment of Myopia with and without Astigmatism by VISUMAX 800  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
V1902PM, Version 1.3 Dated 25.02.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sri Ganesh 
Designation  Principal Investigator 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  Nethradhama Superspeciality Eye Hospital,No 256/14,Phaco & Refractive Department,2nd floor, OPD Block, Kanakapura main road,Jayanagar 7 th block, Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sri Ganesh 
Designation  Principal Investigator 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  Nethradhama Superspeciality Eye Hospital,No 256/14,Phaco & Refractive Department,2nd floor, OPD Block, Kanakapura main road,Jayanagar 7 th block, Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr T Vijay Bhaskar 
Designation  Director 
Affiliation  Invitro Research Solutions Pvt. Ltd 
Address  InVitro Research Solutions Pvt Ltd,no 22&23,3rd floor, Room no 302,Kodigehalli Main Road, Sahakarnagar,Bangalore

Bangalore
KARNATAKA
560092
India 
Phone  6366575282  
Fax    
Email  vijay@ivrs.org.in  
 
Source of Monetary or Material Support  
Carl Zeiss Meditec AG,Göschwitzer Strasse 51-52 07745 Jena Germany 
 
Primary Sponsor  
Name  Carl Zeiss Meditec AG 
Address  Göschwitzer Strasse 51-52 07745 Jena Germany 
Type of Sponsor  Other [Medical Technology Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Germany
Denmark
Hong Kong
India
United Kingdom  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sri Ganesh  Nethradhama Superspeciality Eye Hospital  256/14, 2 nd floor, Phaco & Refractive department, kanakapura main road,7th block , jayanagar , Bangalore
Bangalore
KARNATAKA 		 9845129740

phacomaverick@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama Superspeciality Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H522||Astigmatism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Standard SMILE technique  Standard SMILE technique performed using standard laser settings Frequency: 2 MHz 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Myopia up to -10 D with and without astigmatism up to 5D.
-Age of 18 years or older.
-pre-operative CDVA of 20/25 or better in each eye.
-patient shall be willing to comply with all follow-up visits and the respective examinations.
-Patients should be able to understand the patient information and willing to sign an informed consent.
-Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses. 
 
ExclusionCriteria 
Details  -No monovision treatments (target sphere may not be more negative than -0.25 D)
-The patient may not participate in other ophthalmologic studies except in VEMOS study at site Aarhus .
-Any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study.
-The patients presenting at least one of the contraindications stated in User Manual of the VISUMAX 800 option ReLEx SMILE must not be included in this clinical investigation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Determination of the percentage of eyes with post-operative spherical equivalent (minus target spherical equivalent) within ±0.5 D with an accuracy of ±4% post-operatively.
2)Determination of the percentage of eyes with a post-operative astigmatism ≤0.5 D with an accuracy of ±4% post-operatively.
3)Determination of the mean difference of post-operative UDVA minus pre-operative CDVA with a half width of their 95%-confidence interval of 0.02 logMAR or lower 		 1 week, 1 month, 3 months and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
-Distribution of CDVA change against baseline for all post-op visits (except 1day)
-Cumulative distribution of post-operative CDVA for all post-op visits
-Distribution of pre-op and post-op manifest astigmatism
-Pre-op and 6-month post-op mesopic contrast sensitivity and their difference
-Cumulative distribution of post-op UDVA (compared to pre-op CDVA)  		 1 week, 1 month, 3 months and 6 months  
 
Target Sample Size   Total Sample Size="237"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "237"
Final Enrollment numbers achieved (India)="61" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/05/2021 
Date of Study Completion (India) 25/03/2023 
Date of First Enrollment (Global)  01/05/2021 
Date of Study Completion (Global) 25/03/2023 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The prospective, non- randomized, international, multicentre, PMCF study, bilateral treatment study aims to collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine.Informed consent will be obtained from all the participants. Follow ups will be conducted at day 1, 1 week, 1 month ,3 months, 6 months  post-surgery. Any complications intra or post operative will be recorded and notified to the ethics committee. 
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