| 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
|
|
|
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
|
|
|
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 VisitSubjects 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 VisitFor 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 UpPostoperative 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 |