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CTRI Number  CTRI/2015/06/005922 [Registered on: 16/06/2015] Trial Registered Retrospectively
Last Modified On: 28/05/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   PROSPECTIVE 
Study Design  Other 
Public Title of Study   Evaluation of change in ability of both eyes to focus simultaneously and muscle balance of eye before and after Relex® Smile refractive surgical procedure to correct short sightedness.  
Scientific Title of Study   Evaluation of ocular alignment and binocular vision before and after RELEX® SMILE for correction of myopia and myopic astigmatism. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Pandey 
Designation  Phacorefractive fellow 
Affiliation  Nethradhama Superspeciality eye hospital 
Address  Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, jayanagar, Bangalore.
256/14, kanakapura main road, 7th block, jayanagar, Bangalore. 560082.
Bangalore
KARNATAKA
560082
India 
Phone  9731809663  
Fax    
Email  drrahulp2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rahul Pandey 
Designation  Phacorefractive fellow 
Affiliation  Nethradhama Superspeciality eye hospital 
Address  Nethradhama Superspeciality eye hospital, 256/14, kanakapura main road, 7th block, jayanagar, bangalore.
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
Bangalore
KARNATAKA
560082
India 
Phone  9731809663  
Fax    
Email  drrahulp2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sri Ganesh 
Designation  Chairman and medical director 
Affiliation  Nethradhama Superspeciality Eye Hospital 
Address  256/14, kanakapura main road, 7th block, jayanagar, bangalore
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
Bangalore
KARNATAKA
560082
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, jayanagar, Bangalore.  
 
Primary Sponsor  
Name  Nethradhama Superspeciality Eye Hospital 
Address  256/14, KANAKPURA ROAD, JAYANAGAR 7TH BLOCK, BANGALORE 560082. 
Type of Sponsor  Research institution and hospital 
 
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 
Rahul Pandey  Nethradhama superspeciality eye hospital  Room no.3, Refractive surgery division,Phacorefractive department, OPD building, 256/14, kanakapura main road, 7th block, jayanagar, Bangalore.
Bangalore
KARNATAKA 		 9731809663

drrahulp2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama superspeciality eye hospital institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy individuals with short sightedness for refractive procedures.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. 21 to 40 years of age
2. Myopia upto10 Ds and astigmatism upto –5 D.
3. Stable corneal conditions within the last 12 months
4. Stable refraction since past 12 months (<0.5D change within past 12 months)
5. Healthy ocular surface with stable tear film
6. Discontinuation of soft contact lenses 1 week, and rigid contact lenses 3 weeks prior to surgery.
7. Willing to participate in study with assured follow up
 
 
ExclusionCriteria 
Details  1. Corneal ecstatic diseases such as Keratoconus suspects or frank keratoconus, keratoglobus, Pellucid Marginal Degeneration.
2. Mixed astigmatism, hyperopia.
3. Moderate to severe dry eye.
4. Socket / globe /lid anomalies, very deep set eyes, nanophthalmos.
5. Severe meibomian gland disease, lid abnormalities.
6. Severe atopy.
7. Contact lens warpage on topography.
8. Severe Contact lens induced ocular allergy.
9. Pregnant and nursing mother.
10. Patients having collagen vascular disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in binocular vision and ocular alignment parameters before and after RELEX SMILE.  Day 15 and 3 months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare computer orthoptic diagnostics (VTS4) with conventional orthoptic diagnostic methods to evaluate ocular alignment and binocular vision.  preop, day1, day15 and 3 month. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   12/03/2015 
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)  Open to Recruitment 
Publication Details   YET TO PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After considering inclusion and exclusion criteria patients will be recruited in the study. all patients will undergo detailed ophthalmic examinations preop, postop day1, 15 and 3 month including- Uncorrected visual acuity, best corrected visual acuity, Subjective and cycloplegic refraction,  Intraocular pressure measurement (NCT), Slit lamp examination, Topography (Orbscan/Pentacam), Dry eye assessment (Schirmer 1, Schirmer 2 and TBUT),  Fundus examination (90D and IDO), Orthoptic workup with conventional methods (Cover, uncover test, PBCT, RAF rule, Random dot stereogram) and by VTS4 (Visual Therapy System) software. Informed consent will be obtained from all patients. Results will be analyzed by using appropriate statistical tests to find the significance of change before and after surgery.

 
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