| 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
|
|
|
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
|
|
|
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. |