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CTRI Number  CTRI/2014/04/004570 [Registered on: 25/04/2014] Trial Registered Retrospectively
Last Modified On: 04/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Results of ReLEx SMILE technique for short sight correction after compensating for eye rotation 
Scientific Title of Study   - Results of ReLEx SMILE for myopic astigmatism after cyclotorsion compensation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2014/ 09  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheetal Brar 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital, Bangalore 
Address  c/0 Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , jayanagar , Bangalore Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal Brar 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital, Bangalore 
Address  c/0 Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , jayanagar , Bangalore Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sri Ganesh 
Designation  Chairman Managing Director 
Affiliation  Nethradhama Superspeciality Eye Hospital, Bangalore 
Address  c/0 Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , jayanagar , Bangalore Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Source of Monetary or Material Support  
Research Foundation Nethradhama Eye Hospital 
 
Primary Sponsor  
Name  Nethradhama Eye Hospital 
Address  c/0 Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , jayanagar , Bangalore  
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 Sheetal Brar  Nethradhama Superspeciality Eye Hospital, Bangalore  c/0 Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , jayanagar , Bangalore
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy individuals undergoing ReLEx SMILE for correction of myopic astigmatism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  ReLEx SMILE procedure   ReLEx SMILE procedure for myopic astigmatism 0.75 D with intraoperative cyclotorsion compensation 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Total number of eyes enrolled in the study will be 60
Patients of both sex, within the age group 21 – 40 years suitable for correction with ReLEx SMILE and who have healthy eyes besides-
1.myopic astigmatism of any degree with manifest cylinder > -0.75 D
2. Adequate Corneal pachymetry (> 480 D)
3. kmax <48D
 
 
ExclusionCriteria 
Details  1. Myopic refractive error with manifest cylinder < -0.75 D or > -5 D
2. Hyperopic astigmatism
3. Irregular astigmatism
4. Inadequate Corneal pachymetry (<480 u)
5. K max >48 D
6. Evidence of keratoconus on corneal topography
7. External ocular disease- severe meibomian gland disease, severe contact lens induced allergy
8. Corneal scars or dystrophies
9. Socket / globe /lid anomalies – very deep set eyes, nanophthalmos

10. Severe meibomian gland disease, lid abnormalities

11. Severe atopy

12. Contact lens overuse

13. Pregnant and nursing mother

14. Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of astigmatism correction and residual cylinder post operatively  post op day 1, day 15 and 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
change in topographic cylinder  post op day 1, day 15 and 3 month 
 
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)   01/03/2014 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The refractive outcome of astigmatism correction has been shown to depend on the accuracy of the axis treatment as any rotational movement of the eyes during treatment may cause shift in the treatment axis leading to undesirable results like undercorrection and induction of aberrations. Most of the currently available excimer laser platforms have the ability to detect and compensate for the static and dynamic cyclotorsion due to positional changes and treatment by advanced softwares and eye tracking. The Visumax femtolaser system at present does not have this feature , hence there is no method is described to compensate for rotational movement during the procedure. Through this study , we describe a method for the compensation of static cyclotorsional movements during ReLEx SMILE procdure in patients with myopic astigmatism (>0.75D), and study the reliability and efficacy of this technique in terms of cylindrical correction and post operative refractive outcome. 
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