| CTRI Number |
CTRI/2022/02/040417 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of visual outcomes of SMILE surgery performed for high myopic astigmatism using a software with Visumax 800(a new laser machine) versus manual technique used with Visumax 500(another laser machine) |
|
Scientific Title of Study
|
Comparison of visual and refractive outcomes of SMILE performed for high myopic astigmatism[greater than or equals to 1.5 D( /=1.5D)] using the OcuLign software with Visumax 800 versus manual cyclotorsion compensation with 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 Managing Director |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Nethradhama superspeciality Eye Hospital,256/14,Kanakapura main road,7th block,Jayanagar,banglore
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Brar |
| Designation |
Senior consultant and research director |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Nethradhama superspeciality Eye Hospital,256/14,Kanakapura main road,7th block,Jayanagar,banglore
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
brar_sheetal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemali Bhavsar |
| Designation |
Fellow |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
Nethradhama superspeciality Eye Hospital,256/14,Kanakapura main road,7th block,Jayanagar,banglore
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
bhavsarhemali91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Superspeciality Eye Hospital,256/14,
kanakapura main road,7th block,jayanagar,Banglore, Karnataka,India |
|
|
Primary Sponsor
|
| Name |
CARL ZEISS MEDITEC |
| Address |
ZEISS,OBBERKOCHEN,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 Sheetal Brar |
Nethradhama Superspeciality Eye Hospital |
Phaco refractive department,2nd floor,OPD block,256/14 Kanakapura main road,Jayanagar,7th block
Bangalore
KARNATAKA |
9591002092
brar_sheetal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Superspeciality Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H522||Astigmatism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Astigmatism treatment by Visumax 800 using OcuLign Software |
Visual and Refractive outcomes after using OcuLign software in Visumax800 for astigmatism treatment |
| Comparator Agent |
Astigmatism treatment by Visumax500 using manual cyclotorsion compensation |
Visual and Refractive outcomes after using manual cyclotorsion compensation for astigmatism with Visumax500 |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)SE between -1D to -10D
2)Astigmatism upto -5D |
|
| ExclusionCriteria |
| Details |
1)keratoconus
2)Pellucid marginal degeneration or suspect cornea
3)severe dry eye or meibomian gland disease
4)glaucoma
5)retinal diseases
6)pregnancy
7)patients on immunosupressants
8)patients with unassured follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcomes of astigmatism correction with the use of OcuLign software in Visumax800 |
1)post-op day1
2)post-op day7
3)post-op day180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety and efficacy of OcuLign software in Visumax 800 |
1)post day1
2)post-op day7
3_post-op day 180 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/02/2022 |
| 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="1"
Months="0"
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 evaluate the visual and refractive outcomes of SMILE surgery performed for high myopic astigmatism (>/= 1.5 D) using OcuLign software and the results will be compared with VIsual and refractive outcomes of SMILE surgery performed for high astigmatism using Manual cyclotorsion compensation used with Visumax500 laser machine. A total of 50 eyes treated with Visumax800 satisfying inclusion criteria will be taken into study.Post-operatively this data will be analysed with a retrospective data of another 50 eyes from 50 patients who underwent SMILE for myopic astigmatism treated with manual compensation using ink marking method with the visumax500 femto laser. |