FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/04/004537 [Registered on: 09/04/2014] Trial Registered Retrospectively
Last Modified On: 04/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of outcomes and patient satisfaction between three procedures for correction of low to moderate short sightedness 
Scientific Title of Study   “Matched population comparison of visual outcomes and patient satisfaction between three treatments modalities for the correction of low to moderate myopia and myopic astigmatism”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2014/10  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 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block 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 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block 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/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block 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 Research Foundation 
Address  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore  
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 
Dr Sheetal Brar  Nethradhama Superspeciality Eye Hospital, Bangalore  c/o Nethradhama superspeciality eye hospital No 256/14, kanakapura main road Jayanagar 7 th block Bangalore
Bangalore
KARNATAKA 		 9591002092

brar_sheetal@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
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  patients with healthy eyes besides low to moderate myopic astigmatism ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FEMTO LASIK  FEMTO LASIK procedure will be performed in suitable patients satisfying inclusion criteria 
Intervention  ICL (V4C) MODEL  ICL (V4C) MODEL implantation in suitable patients satisfying inclusion criteria 
Comparator Agent  ReLEx SMILE  ReLEx SMILE procedure will be performed in suitable patients satisfying inclusion criteria 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  ICL group A:
Inclusion criteria:

Any gender, 21 to 45 years of age

ACD (endo) ≥ 3mm

Myopia between -3 to -8 D and astigmatism between upto -3D

Stable corneal conditions within the last 12 months
FEMTO-LASIK group B:
Inclusion criteria
Any gender between 21 to 45 years of age

Myopia between -3 to -8 D and astigmatism upto - 3 Dcyl

Stable corneal conditions within the last 12 months

Stable refraction since past 12 months(<0.5D change within past 12 months)

Healthy ocular surface with stable tear film

Discontinuation of Soft contact lenses 1 week , and rigid contact lenses 3 weeks prior to surgery

SMILE group C:
Inclusion criteria
Any gender , 21 to 45 years of age

Myopia between -3 to -8 D and astigmatism upto - 3 Dcyl

Stable corneal conditions within the last 12 months

Stable refraction since past 12 months(<0.5D change within past 12 months)

Healthy ocular surface with stable tear film

Discontinuation of Soft contact lenses 1 week , and rigid contact lenses 3 weeks prior to surgery

 
 
ExclusionCriteria 
Details  Exclusion criteria:

Age of less than 21 or more than 45 years.

ACD (endo) < 3 mm

Myopia outside -3 to -8 D range or astigmatism > 3 D

Keratoconus

Cataract or glaucoma

Pregnant or nursing mothers

Abnormal endothelial cell count

Irido-corneal angles less than Grade III

Exclusion criteria- applicable to both F-LASIK and SMILE groups

Myopia > -8 D SE and Manifest cylinder > 5D

Thin corneas ( Corneal pachymetry <480u)

Steep corneas Kmax >48 D

Keratoconus suspects o r frank keratoconus

Mixed astigmatism

Moderate to severe dry eye(Shirmers1 <10 mm)

Socket / globe /lid anomalies – very deep set eyes, nanophthalmos

Severe meibomian gland disease, lid abnormalities

Severe atopy

Contact lens overuse

Pregnant and nursing mother

Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants



 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy, predictability, stability and safety variables (efficacy and safety indexes) and stability over-time
 		 post op day 1, day 15, 3 months, 6 months, 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of contrast sensitivity
Aberrations
Subjective assessment of visual disturbances, patient satisfaction and spectacle independence
Dry eye symptoms
 		 post op day 1, day 15, 3 months, 6 months, 12 months
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 None yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   For appx two decades, photorefractive keratectomy (PRK) and Laser in situ keratimilieusis (LASIK) have been used to correct myopia. However, both procedures have shown to cause some instability of cornea and induction of aberrations for higher powers (>6 D) in long term studies. With the introduction of femtolasers, it is believed that the surgery is more precised and predictable. Neverthless, LASIK always entails the risk of flap related complications , delayed healing , induction of aberrations, night vision problems and ectasia in future. 
With further advancement in technology, we now have alternative options for traeting myopia which are shown to be equivalent or better than the gold standard LASIK. Implantable Collamer Lens(ICL) has been proposed to be a valid option for traeting myopia outside the range of LASIK( > 12 D) and in patients with inadequate corneal thickness or who are unsuitable for keratorefractive procedures. 
Another technique which is relatively recent compared to LASIK ans ICL, is the flapless all femtosecond procedure ReLEx SMILE , is proposed to be effective in treating myopia upto 10 D, with astignatism upto 5 D. 
This study will be undertaken to compare the three currently available modalities ie- ICL, FEMTO LASIK and ReLEx SMILE, for correction of low to moderate myopia and study the long term visual outcomes , safety , efficacy and patient satisfaction in each of the three groups.
 
Close