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CTRI Number  CTRI/2025/04/085340 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 18/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical outcomes of SMILE performed with VISUMAX 800 using different parameters 
Scientific Title of Study   Intraoperative tissue separation and immediate visual quality following SMILE performed with VISUMAX800 using different energy and spot spacing parameters  
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 Sri Ganesh 
Designation  CHAIRMAN, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL. 
Affiliation  CONSULTANT , NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU.
2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU.
Bangalore
KARNATAKA
560070
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Janki Bhayani 
Designation  Phacorefractive Consultant 
Affiliation  Nethradhama superspeciality eye hospital 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK JAYANAGAR, BENGALURU.
2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU.
Bangalore
KARNATAKA
560070
India 
Phone  07357759879  
Fax    
Email  bhayanidrjanki@gmail.com  
 
Details of Contact Person
Public Query  
Name  Janki Bhayani 
Designation  Phacorefractive fellow  
Affiliation  Nethradhama superspeciality eye hospital 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU.
2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU.
Bangalore
KARNATAKA
560070
India 
Phone  07357759879  
Fax    
Email  bhayanidrjanki@gmail.com  
 
Source of Monetary or Material Support  
No source 
 
Primary Sponsor  
Name  ZEISS 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256 14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU. 
Type of Sponsor  Private hospital/clinic 
 
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 
DrJanki Bhayani   Nethradhama Superspeciality Eye Hospital  Phcorefractive department, OPD block, second floor
Bangalore
KARNATAKA 		 7357759879

bhayanidrjanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama super speciality eye hospital institutional ethics committtee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SMILE surgery with VISUMAX 800  Tissue separation and immediate visual acuity of patients undergoing SMILE by altering different spot spacing parameters  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  myopia or myopic astigmatism between -2 to -10D 
 
ExclusionCriteria 
Details  patients with keratoconus, dry eye, PMD. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
UCVA ,CVA
MANIFEST FREFRACTION OSI MTF 		 pod1 , pod 15 
 
Secondary Outcome  
Outcome  TimePoints 
OSI MTF   post op 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/04/2025 
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)   Open to Recruitment 
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  
Intra-operative tissue separation and immediate visual quality following
SMILE performed with VISUMAX 800 using different energy and spot spacing
parameters


A total of 30 non-consecutive patients will receive treatment with the following 6 groups of spot
separation settings, with n=5 patients ( n=10 eyes) in each group.

During and at the end of the procedure, the following parameters will be
evaluated:

1. Time taken for laser delivery ( sec)
2. Severity of the Opaque Bubble Layer( OBL) graded as <25%, <50%,
<75% and & 100%
3. Ease of lenticule extraction using the “ No-dissection/ Lenticuloschisis
technique” on a grade of 1-5 
4.Number of times Lenticuloschsis could not be performed or was
converted to conventional dissection technique.
 
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