| CTRI Number |
CTRI/2022/11/047703 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
26/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of time taken for SMILE surgery of both eyes performed with 2 different machines |
|
Scientific Title of Study
|
Comparison of intra-operative time taken for docking, lenticule dissection and overall workflow for bilateral SMILE performed with VisuMax 800 versus VisuMax 500. |
| 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, Bangalore |
| Address |
Nethradhama Superspeciality Eye Hospital,OPD Block,room SF-10,phaco & refractive department, 256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9845129740 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Brar |
| Designation |
Senior consultant |
| Affiliation |
Nethradhama Superspeciality Eye Hospital, Bangalore |
| Address |
Nethradhama Superspeciality Eye Hospital,OPD Block,room SF-10,phaco & refractive department, 256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9591002092 |
| Fax |
|
| Email |
brar_sheetal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhu Bhargav |
| Designation |
Fellow |
| Affiliation |
Nethradhama Superspeciality Eye Hospital |
| Address |
Nethradhama Superspeciality Eye Hospital,OPD Block,room SF-10,phaco & refractive department, 256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9739596891 |
| Fax |
|
| Email |
bhargav.sindhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama superspeciality eye hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
Carl Zeiss Meditech |
| Address |
Zeiss, Oberkochen, Germany |
| Type of Sponsor |
Research institution |
|
|
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 Sindhu Bhargav |
Nethradhama Superspeciality Eye Hospital, bangalore |
Nethradhama Superspeciality Eye Hospital, Phacorefractive department, 2nd floor, OPD Block, 256/14 Kanakapura main road, Jayanagar 7th block, Bangalore
Bangalore
KARNATAKA |
9739596891
bhargav.sindhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama superspeciality eye hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
30 pateints undergoing bilateral RELEX SMILE procedure on VisuMax 500 |
Intraoperative time taken for docking, lenticule dissection and overall workflow is recorded |
| Intervention |
30 pateints undergoing bilateral RELEX SMILE procedure on VisuMax 800 over 6 months |
Intraoperative time taken for docking, lenticule dissection and overall workflow is recorded |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
age >21 years to 40 years, pre-op myopia or myopic astigmatism with SE between -1.00 to -10.00 D and manifest cylinder < 1.50 D ( not requiring limbal marking) |
|
| ExclusionCriteria |
| Details |
Refractive cylinder >1.5 D, keratoconus, pellucid marginal degeneration or suspect cornea, severe dry eye or meibomian gland disease, glaucoma or retinal disease, pregnancy, patients on immunosuppressants and 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 compare the time to perform different steps of the same procedure between 2 machines |
intraoperative time
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess uncorrected and corrected distance visual acuity, subjective refraction and optical scatter index of both eyes |
post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2022 |
| 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="0"
Months="6"
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
|
to investigate and compare the overall workflow of performing bilateral SMILE procedure using the VisuMax 800 versus the VisuMax 500 FS laser in terms of the overall time taken to complete a bilateral procedure, docking of each eye, lenticule separation of each eye and if these have any implications on 1st post-operative day in terms of visual and refractive results and quality of vision obtained. Clinically, this study would help us to evaluate if the faster frequency and other advanced features of the VisuMax 800, have advantages, if any, for improving the overall efficiency and enhancing patient experience while undergoing a bilateral SMILE procedure, compared to VisuMax 500 FS laser. |