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CTRI Number  CTRI/2020/01/022842 [Registered on: 17/01/2020] Trial Registered Prospectively
Last Modified On: 15/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Study to correlate bubble layer formed in cornea with strength of corneal layers during laser surgery for short sight. 
Scientific Title of Study   Clinical study to evaluate the correlation of opaque bubble layer(OBL) with corneal biomechanics and densitometry in eyes undergoing SMILE for myopic correction. 
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 
Affiliation   
Address  256/14, 2nd floor, Phaco Refractive department, Nethradhama Superspeciality Eye Hospital, 7th block, Jayanagar, Bangalore- 560070

Bangalore
KARNATAKA
560070
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SRI GANESH 
Designation  Chairman 
Affiliation   
Address  256/14, 2nd floor, Phaco refractive department, Nethradhama superspeciality eye hospital, 7th block, Jayanagar, Bangalore- 560070

Bangalore
KARNATAKA
560070
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SRI GANESH 
Designation  Chairman 
Affiliation   
Address  256/14, 2nd floor, Phaco refractive department, Nethradhama superspeciality eye hospital, 7th block, Jayanagar, Bangalore- 560070

Bangalore
KARNATAKA
560070
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama superspeciality eye hospital 
 
Primary Sponsor  
Name  Nethradhama superspeciality eye hospital 
Address  256/14,Kanakapura main road , 7th block, jayanagar, Bangalore- 560070 
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 Sri Ganesh  Nethradhama superspeciality eye hospital  256/14, 2nd floor, Phaco refractive dept, 7th block, jayanagar, Bangalore- 560070
Bangalore
KARNATAKA 		 9845129740

phacomaverick@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committe for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  SMILE surgery  Corneal lenticule will be removed after application of femtosecond laser. Application of laser creates opaque bubble layer, this will be correlated with corneal biomechanics and densitometry. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  spherical equivalent up to −10 diopters (D)
age of 21 years or older
stable refraction for at least 1 year
soft contact lens use discontinued for 1 week and rigid gas permeable lens use discontinued for 3
weeks prior to the procedure
minimum corneal thickness of 480 μm
residual stromal bed of at least 250 μm
ability to understand and willingness to participate in all follow-up visits. 
 
ExclusionCriteria 
Details  evidence of residual or active ocular diseases such as herpetic keratitis, uveitis, glaucoma
visually significant cataract, retinal diseases such as retinal dystrophies or diabetic retinopathy,
corneal dystrophies, keratoconus
history of corneal trauma or surgery, severe dry eyes (Schirmer’s 2 test value < 10 mm)
use of systemic medications likely to affect wound healing (eg, corticosteroids or antimetabolites)
immunocompromised state
Women who are pregnant or nursing 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
UCVA, BCVA  Pre operative visit, post operative day 1 and day 15 
 
Secondary Outcome  
Outcome  TimePoints 
UCVA, BCVA  Post operative day 15 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 4 
Date of First Enrollment (India)   20/01/2020 
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   1)Jeewan S Tityal, Kaur M, Shaikh F, Gagrani M, Brar AS, Rathi A. Small incision lenticule extraction(SMILE) techniques: patient selection and perspectives. Clinical Ophthalmology. 2018: 1685-1699. 2)Joaquin Fernandez. New parameters for evaluating corneal biomechanics and intraocular pressure after small incision lenticule extraction by schiempflug-based dynamic tonometry. Journal of Cataract and Refractive Surgery. 2017 jun;43(6);803-812. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   To evaluate the correlation of opaque bubble layer(OBL)  with corneal biomechanics and densitometry in eyes undergoing SMILE for myopic correction. OBL can be observed in cases with too high or too low energy settings and results in increased adhesions with difficult dissection. Formation of OBL depends on biomechanical strength of cornea.  
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