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CTRI Number  CTRI/2014/10/005084 [Registered on: 08/10/2014] Trial Registered Retrospectively
Last Modified On: 28/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of two refractive surgery techniques ReLEx SMILE and PRK for the correction of low degrees of short sightedness 
Scientific Title of Study   Comparison of ReLEx SMILE and PRK in terms of visual and refractive outcomes and patient satisfaction for the correction of low myopia 
Trial Acronym  SMILE VS PRK 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR UTSAV PATEL 
Designation  PHACO REFRACTIVE FELLOW 
Affiliation  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  NETHRADHAMA SUPER SPECIALITY EYE HOSPIAL # 256/14, Kanakapura Main Road, 7th Block, Jayanagar

Bangalore
KARNATAKA
560082
India 
Phone  09901903149  
Fax    
Email  utsav_5093@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  DR UTSAV PATEL 
Designation  PHACO REFRACTIVE FELLOW 
Affiliation  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  NETHRADHAMA SUPER SPECIALITY EYE HOSPIAL # 256/14, Kanakapura Main Road, 7th Block, Jayanagar


KARNATAKA
560082
India 
Phone  09901903149  
Fax    
Email  utsav_5093@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR SRI GANESH 
Designation  CMD 
Affiliation  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  NETHRADHAMA SUPER SPECIALITY EYE HOSPIAL # 256/14, Kanakapura Main Road, 7th Block, Jayanagar

Bangalore
KARNATAKA
560082
India 
Phone  09845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Source of Monetary or Material Support  
NETHRADHAMA SUPER SPECIALITY EYE HOSPIAL  
 
Primary Sponsor  
Name  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  # 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560 082. Bangalore KARNATAKA 560100 India 
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 UTSAV PATEL  NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, PHACO AND REFRACTIVE DEPARTMENT,  # 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560 082
Bangalore
KARNATAKA 		 09901903149

utsav_5093@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Nethradhama Superspeciality Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with low degrees of myopia (Spherical equivalent of -4D),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PRK (Photo Refractive Keratectomy)  Under topical anaesthesia, a 9mm optical zone marker will be applied firmly to the corneal surface, centered on the visual axis, and filled with 20% ethanol in balanced salt solution. After 30 seconds, the ethanol is absorbed with a sponge, with care taken to avoid spillage on the areas not being treated; the cornea washed with Balanced Salt Solution (BSS). The loose epithelium is then removed as a sheet by lifting the edge of the loosened epithelium with sharp Beaver blade. Eximer laser ablation will then be carried out using the MEL 90 (Carl Zeiss Meditec AG). After the ablation procedure, Mitomycin- C 0.02% is applied to the ablated surface for 20 seconds,and washed with copious BSS and bandage contact lens applied, which will be removed after 4 days of surgery. 
Intervention  ReLEx SMILE (Refractive Lenticule Extraction, Small Incision Lenticule Extraction)  Under topical anaesthesia, VisuMax femtosecond laser (Carl Zeiss Meditec AG) will be used for the small- incision lenticule extraction. The patient will be positioned under the curved contact glass of the femtosecond laser and asked to fixate on a blinking target. When appropriate centration (center of pupil) is observed, suction will be applied. Femtosecond laser pulses (500 kHz) will be used, first in a spiral-in pattern to achieve the cut at the deeper plane of intra-stromal lenticule, followed by spiral-out laser for superficial cut. The lenticule diameter (optical zone) will be 6.0 to 7mm, cap diameter 7.5mm and cap thickness of 100µ. A 2mm incision will be created by the femto laser located at 12 oclock. Following creation of lenticule, the incision will be opened to identify the two planes of lenticule. A thin blunt spatula will be used to dissect the superficial and deep planes of the lenticule and to break the remaining tissue bridges thus separating the lenticule from the surrounding stroma. This lenticule will be grasped with a pair of forceps and extracted through the 2mm incision. The corneal interface will be then flushed with balanced salt solution. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  •Myopia with SEQ < - 4 D with cylinder upto - 2 D

•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  •Thin corneas (Corneal pachymetry <480u)

•Steep corneas Kmax >48 D

•Keratoconus suspects or 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

•Autoimmune disorders

•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 
Matched population comparison of refractive and visual outcomes and patient satisfaction between ReLEx SMILE and PRK for the correction of low myopia (SEQ 4D)  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
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   Phase 1 
Date of First Enrollment (India)   01/09/2014 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A prospective study comparing the two refractive procedures ReLEx SMILE and PRK in patients between the age of 21 years and 40 years in terms of visual and refractive outcomes and patient satisfaction for the correction of low myopia (Spherical equivalent < -4D) will be conducted over a period of 6 months.

PREOPERATIVE PARAMETERS

 Patient demographic parameters:

·         Patient(N)

·         Sex(M/F)

·         Age(Y)

Visual parameters:

·         UCVA

·         BSCVA

·         Manifest refraction: Magnitude of Sphere (D), Magnitude of Cylinder(D), Spherical equivalent(D).

·         Retinoscopy refraction

Pre-op Assessment

·         Anterior segment (Slit lamp biomicroscopy)

 Â·         Dilated Fundus of the eye including periphery (Indirect ophthalmoscopy)

 Â·         Intraocular Pressure (NCT)

 Â·         Axial length (IOL Master)

 Â·         Topography (Orbscan II and Sirius)

 Â·         Aberrometry and pupil size (I trace)

 Â·         Contrast Sensitivity (FACT)

 Â·         Specular Microscopy (ECD)

 Â·   Dry eye assessment (Shirmers I, II and TBUT)

POST-OPERATIVE PARAMETERS

FOLLOW UP EXAMINATION SCHEDULE - Day 1, 15 and 3 months post op

 

Follow-up examination - 1 day postop for ReLEx SMILE & day 4 postop PRK

·         Uncorrected distant Visual acuity (in Logmar, ETDRS charts at 6m)

·         SL Exam – Corneal state, haze

·         AE

Follow-up examination (15 days postop)

·         Uncorrected distant Visual acuity (in Logmar, ETDRS charts at 4m)

·         Subjective refraction

·         IOP (NCT)

·         Topography (Orbscan + Sirius + CRS Master)

·         Aberrations (I Trace)

·         AS-OCT – epithelial thickness profile

·         Contrast sensitivity( FACT)

·         AE

·         Subjective questionnaire

 

Follow-up examination (3 months postop)

·         Uncorrected distant Visual acuity (in Logmar, ETDRS charts at 4m)

·         Subjective refraction

·         IOP (NCT)

·         Topography (Orbscan+Sirius + CRS Master)

·         Aberrations (I Trace)

·         AS-OCT – epithelial thickness profile

·         Contrast sensitivity( FACT)

·         AE

·         Subjective assessment (questionnaire) satisfaction, spectacle independence, Halo and glare assessment

·         Dry eye assessment (Shirmers I, II, TBUT)

·         Specular Microscopy (ECD)

 
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