FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099788 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Analysis of results achieved and experience of trainee refractive surgeons in learning SMILE pro surgery for minus power correction using VISUMAX 800 laser 
Scientific Title of Study   Analysis of Initial Clinical Outcomes and Performance in Lenticule Extraction with SMILE Pro Performed by Refractive Surgeons Training in SMILE Pro Using the VISUMAX 800 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IIH-IEC/2025/VISUMAX800/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheetal Brar 
Designation  Medical Director 
Affiliation  ProSight Eye Hospital 
Address  ProSight Eye Hospital SCO 146 Sector 43

Chandigarh
CHANDIGARH
160043
India 
Phone  9591002092  
Fax    
Email  sheetalbrar1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sheetal Brar 
Designation  Medical Director 
Affiliation  ProSight Eye Hospital 
Address  ProSight Eye Hospital SCO 146 Sector 43

Chandigarh
CHANDIGARH
160043
India 
Phone  9591002092  
Fax    
Email  sheetalbrar1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sheetal Brar 
Designation  Medical Director 
Affiliation  ProSight Eye Hospital 
Address  ProSight Eye Hospital SCO 146 Sector 43

Chandigarh
CHANDIGARH
160043
India 
Phone  9591002092  
Fax    
Email  sheetalbrar1@gmail.com  
 
Source of Monetary or Material Support  
ProSight Eye Hospital, Chandigarh 
 
Primary Sponsor  
Name  ProSight Eye Hospital 
Address  sector 43 B SCO 146 Chandigarh 160043 
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 
Dr Sheetal Brar  ProSight Eye Hospital  Phaco Refractive department Room number 1 SCO 146 sector 43 B
Chandigarh
CHANDIGARH 
09591002092

sheetalbrar1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indus International Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  myopic individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  No comparator agent 
Intervention  SMILE Pro   It is flapless and minimally invasive form of laser vision correction for surgical myopia correction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Stable refraction
Myopia between -1 to -10 SE
Astigmatism within 5 D
Suitable topography
Healthy ocular surface
Healthy optic nerve and retina 
 
ExclusionCriteria 
Details  severe dry eye
keratoconus
ocular infections
pregnancy
immunosuppession 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
post op uncorrected visual acuity  post op day 1 and 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Docking time: Time from insertion of the eye speculum to laser activation (minutes). The time will be taken using a stopwatch and recorded by the same person.
- Docking success rate: Percentage of eyes achieving successful docking and challenges encountered.
- Lenticule dissection and extraction time: Time required to dissect and remove the lenticule (minutes).
- Total surgical time: Time from speculum insertion to removal for one eye (minutes).
-Complications 
Intra-operative 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   05/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The Lenticule Extraction procedure is technically more challenging compared to LASIK, primarily due to the higher surgical skills required for manual docking, precise centration, laser energy optimization, and the smooth, complication-free extraction of the corneal refractive lenticule. These requirements underscore the need for meticulous surgical planning and execution.

 

Several surgical challenges have been reported during the learning curve, including suction losses, black spots, lenticule misplacement, cap or incision tears, and lenticule retention. These data reflect the experience with SMILE using the VisuMax femtosecond laser. However, the recently introduced VISUMAX 800 femtosecond laser (Carl Zeiss Meditec, Jena, Germany) offers several significant advancements over its predecessor. Key improvements include a much faster 2-megahertz laser frequency, a centration aid (CentraLign), a cyclotorsion alignment feature (OcuLign), separate laser and microscope arms, and a heads-up docking mechanism achieved by lowering the laser arm instead of raising the patient’s bed. These enhancements make the VISUMAX 800 a faster and possibly more efficient platform for performing the minimally invasive Lenticule Extraction procedure.

 

With these advancements, it is particularly interesting to evaluate how the VISUMAX 800 performs in the hands of refractive surgeons who are proficient in PRK and LASIK but new to Lenticule Extraction and SMILE Pro. Specifically, it would be valuable to assess whether the new features help reduce the challenges associated with the SMILE learning curve and minimize complications during initial procedures.

 

This observational study aims to analyze the learning curve of SMILE Pro for refractive surgeons using the VISUMAX 800 femtosecond laser. Key aspects to be evaluated include docking efficiency, laser delivery precision, lenticule dissection and removal, surgical time, and clinical outcomes. By focusing on these parameters, the study seeks to provide valuable insights into the role of advanced technology in facilitating safer and more efficient training for surgeons already skilled in laser refractive surgery.

 

 
Close