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CTRI Number  CTRI/2022/03/040950 [Registered on: 09/03/2022] Trial Registered Prospectively
Last Modified On: 08/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing the quality of vision and outcomes in normal versus large angle kappa patients undergoing Smile surgery with Visumax 800 machine 
Scientific Title of Study   Comparison of visual and refractive results, induced aberrations and objective scatter index in normal versus large angle kappa following Smile performed with Visumax 800 
Trial Acronym   
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 Medical Director 
Affiliation  Nethradhama SuperSpeciality Eye Hospital 
Address  Nethradhama SuperSpeciality Eye Hospital, Phaco-Refractive department, 2nd floor, OPD block, 256/14 Kanakapura Main Road, Jayanagar 7th Block, Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal Brar 
Designation  Senior consultant and Research Director 
Affiliation  Nethradhama SuperSpeciality Eye Hospital 
Address  Nethradhama SuperSpeciality Eye Hospital, Phaco-Refractive department, 2nd floor, OPD block, 256/14 Kanakapura Main Road, Jayanagar 7th Block, Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shadwala Bharti 
Designation  Fellow 
Affiliation  Nethradhama SuperSpeciality Eye Hospital 
Address  Nethradhama SuperSpeciality Eye Hospital, Phaco-Refractive department, 2nd floor, OPD block, 256/14 Kanakapura Main Road, Jayanagar 7th Block, Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  8006880412  
Fax    
Email  shadwalabharti08@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama SuperSpeciality Eye Hospital, 256/14 kanakapura road, 7th block,Jayanagar, Bangalore,Karnataka 
 
Primary Sponsor  
Name  Zeiss Meditec  
Address  Zeiss Meditec, Obberkochen, Germany 
Type of Sponsor  Research institution 
 
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 
Dr Sheetal Brar  Nethradhama SuperSpeciality Eye Hospital  Opd building,second floor, 256/14, Kanakapura main road, Jayanagar 7th Block, Bangalore.
Bangalore
KARNATAKA 		 9591002092

brar_sheetal@yahoo.co.in 
 
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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Smile surgery with Visumax 800 laser machine for patients with large angle kappa  Visual and refractive outcomes after using Visumax 800 for large angle kappa at post op day-1, post op day-7 and post op day 3 months 
Comparator Agent  Smile surgery with Visumax 800 laser machine for patients with normal angle kappa  Visual and refractive outcomes after using Visumax 800 for normal angle kappa at post op day-1, post op day-7 and post op day 3 months 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  SE between -1 to -10 D, astigmatism up to -5 D. 
 
ExclusionCriteria 
Details  1)Keratoconus,
2)pellucid marginal degeneration or suspect cornea, 3)severe dry eye or meibomian gland disease, 4)glaucoma or
5)retinal disease,
6)pregnancy,
7)patients on immunosuppressants
8)patients with unassured follow ups. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and compare visual and refractive results, induced aberrations and objective scatter index in normal versus large angle kappa following Smile performed with Visumax 800.  POD 1, POD 7, PO 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the centration guide feature of the Visumax 800 in eyes with large angle kappa.  POD 1, POD 7, PO 3 MONTHS 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   21/03/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Centration of treatment zone during corneal laser procedures has always been a principle aim for a refractive surgeon to obtain good outcomes. Currently with Viumax 500 laser machine, no iris or pupil registration is available to guide the surgeon in treatment centration, nor it has any correction factor to compensate for the displaced visual axis in patients with large angle kappa. With new Visumax 800, centration aid is available to centre a vector to predetermined point , giving measurements for deviation of visual from pupillary axis. Using centration aid, intra-operative centration is expected to be more accurate. 
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