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CTRI Number  CTRI/2026/03/106009 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of preoperative and intraoperative time flow: VisuMax 800 versus VisuMax 500 
Scientific Title of Study   A comparative analysis of the intraoperative and preoperative time flow between visumax 800 vs visumax 500 
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 Supriya Sriganesh  
Designation  Director 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital,256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070 Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  8951027740  
Fax    
Email  dr.supriyasriganesh@nethradhama.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shreya Pai 
Designation  Phaco & Refractive surgery fellow 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital,256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070 Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  9738712712  
Fax    
Email  shreyaspai97@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreya Pai 
Designation  Phaco & Refractive surgery fellow 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital,256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore, Karnataka - 560070 Bangalore KARNATAKA 560070 India


KARNATAKA
560070
India 
Phone  9738712712  
Fax    
Email  shreyaspai97@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama superspeciality eye hospital-256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560070  
 
Primary Sponsor  
Name  Nethradhama superspeciality eye hospital 
Address  Nethradhama superspeciality eye hospital-256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560070  
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 Shreya Pai  Nethradhama Superspeciality Eye Hospital  256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560070 Bangalore KARNATAKA
Bangalore
KARNATAKA 
9738712712

shreyaspai97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  TO evaluate and compare the preoperative and intraoperative time flow between the VISUMAX 500 VS the VISUMAX 800  Visual Acuity Testing, Manifest refraction, Slit lamp Examination, Dilated Fundus Examination, Intraocular Presuure Corneal Topography, MS -39, pupil diameter, AS-OCT, Itrace and in case of patients opting for Visumax 800 IOL master 700 is done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed with Myopic astigmatism
Patient topography suitable to undergo Relex Smile Pro
 
 
ExclusionCriteria 
Details  Patient with Hypermetropia, presbyopia
Borderline Topography
High Myopia not suitable for keratorefractive surgery
Uncooperative and anxious patients (increases time hence confounding the results)
Pupillary Abnormality
Any other Ocular Surface Disturbances
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome is correction of the refractive error and also to compare the time taken between visumax 500 and 800  Outcome is correction of the refractive error and also to compare the time taken between visumax 500 and 800 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   31/03/2026 
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="0"
Months="6"
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  

Introduction

Small incision lenticule extraction (SMILE) and other femtosecond laser assisted keratorefractive procedures are well established options for the correction of myopia and myopic astigmatism, with high efficacy, safety, and predictability across large clinical series. Over the past decade, device evolution from the first generation VISUMAX 500 (500 kHz) to the second generation VISUMAX 800 (2 MHz) has focused not only on visual outcomes but also on workflow efficiency, with the newer platform designed to shorten laser time, docking time, and overall procedural duration.

The VISUMAX 800 features a higher pulse repetition rate and upgraded scanning system that allow refractive lenticule creation in less than 10 to 11 seconds compared with approximately 25 to 30 seconds on the VISUMAX 500, and can reduce total surgical time by approximately 1.5 to 2 minutes per case without compromising visual results. Recent comparative studies have demonstrated significantly shorter docking time, laser time, and overall surgical time with the VISUMAX 800 while maintaining similar refractive accuracy, safety indices, higher order aberrations, and contrast sensitivity when compared with the VISUMAX 500.

Beyond intraoperative timing, the cumulative time from preoperative assessment to completion of surgery including diagnostics, counseling, preparation, laser treatment, and immediate postoperative evaluation directly influences operating room throughput, staff utilization, and patient experience in high volume refractive centers.

Although published data confirm intraoperative time savings with the VISUMAX 800, there is limited evidence quantifying how this translates into overall perioperative time flow across the entire patient pathway when compared with the VISUMAX 500.

A structured evaluation of time flow from preoperative assessment to completion of surgery for VISUMAX 800 versus VISUMAX 500 can therefore provide critical information for service planning, scheduling, and resource allocation in refractive surgery units. By mapping and comparing time points at key steps such as preoperative diagnostics, slit lamp evaluation, consent and counseling, surgical preparation, docking, laser delivery, and immediate postoperative checks, this study aims to determine whether the newer platform delivers meaningful gains in overall efficiency without compromising clinical outcomes or patient reported experience.

Aim

To evaluate and compare the preoperative and intraoperative time flow between the VISUMAX 500 and the VISUMAX 800.

Material and Methods

This prospective observational single center study will be approved by the Institutional Ethics Committee of Nethradhama Superspeciality Eye Hospital and will adhere to the tenets of the Declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.

Preoperative Visit

Subjects will provide demographic information and medical history and will undergo the following assessments at the preoperative visit. The time taken to conduct each test will be recorded.

Visual acuity testing
Manifest refraction
Slit lamp examination
Dilated fundus examination
Intraocular pressure measurement
Corneal topography
MS 39
Pupil diameter measurement
Anterior segment optical coherence tomography
ITrace analysis
In patients opting for VISUMAX 800, IOL Master 700 measurement will also be performed

Operative Visit

For patients undergoing SMILE on the VISUMAX 500, preoperative axis marking will be performed on the slit lamp prior to shifting to the operating theater, and the time taken for this step will be recorded.

The time taken by optometrists to evaluate the patient, change into surgical scrubs, and enter patient data into the VISUMAX 500 will be recorded. For the VISUMAX 800, the time taken for remote data transfer will be noted.

Intraoperative time including patient transfer, bed positioning, docking, laser firing, and lenticule dissection will be recorded.

Postoperative Follow Up

Postoperative evaluations will be conducted at day 1, 2 weeks, and 3 months after surgery and will include:

Slit lamp examination
Measurement of uncorrected and corrected distance visual acuity using ETDRS charts
Manifest refraction
Objective scatter index and modulation transfer function using HD analyzer

 
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