| CTRI Number |
CTRI/2015/01/005472 [Registered on: 28/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
27/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Results and Safety of a laser surgical procedure(ReLEx SMILE) to correct myopia(short sightedness)in 600 eyes |
|
Scientific Title of Study
|
Visual and Refractive Outcomes with ReLEx® SMILE in 600 Eyes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishika Gupta |
| Designation |
phaco and refractive surgery fellow |
| Affiliation |
Nethradhama SuperSpeciality Eye Hospital |
| Address |
Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakpura Main Road, 7th block Jayanagar, Bangalore-560082, India
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
rishikagupta55@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rishika Gupta |
| Designation |
phaco and refractive surgery fellow |
| Affiliation |
Nethradhama SuperSpeciality Eye Hospital |
| Address |
Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakpura Main Road, 7th block Jayanagar, Bangalore-560082, India
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
rishikagupta55@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishika Gupta |
| Designation |
phaco and refractive surgery fellow |
| Affiliation |
Nethradhama SuperSpeciality Eye Hospital |
| Address |
Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakpura Main Road, 7th block Jayanagar, Bangalore-560082, India
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
rishikagupta55@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Superspeciality Eye Hospital |
|
|
Primary Sponsor
|
| Name |
Nethradhama Superspeciality Eye Hospital |
| Address |
Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakpura Main Road, 7th block Jayanagar, Bangalore-560082, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rishika Gupta |
Nethradhama Superspeciality Eye Hospital |
Nethradhama SuperSpeciality Eye Hospital,phaco and refractive surgery department, consultation room 1, 256/14, Kanakpura Main Road, 7th block Jayanagar, Bangalore-560082, India
Bangalore
KARNATAKA |
09886309097
rishikagupta55@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nethradhama superspeciality eye hospital institutional ethics committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RELEX SMILE : surgical procedure to correct myopia
comparator agent : not applicable |
patients undergoing surgery for correction of myopia underwent a thorough pre-operative evaluation including :best corrected vision, contrast sensitivity and aberrations, which were compared with postoperative variables : uncorrected vision, contrast sensitivity and aberrations. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
myopia between 1 to 10 diopters (D), astigmatism upto 5D, and spherical equivalent upto 10D, an age of 21 years or older, a stable refraction for atleast 1 year, the discontinuation of soft contact lenses for a minimum of 1 week and rigid gas permeable contact lens discontinuation for a minimum of 3 weeks, a minimum corneal thickness of 480µm, a residual corneal thickness of atleast 250µm or 50% of original thickness (whichever was higher), the ability to understand and a willingness to sign informed consent, and a willingness to participate in all follow-up visits. |
|
| ExclusionCriteria |
| Details |
eyes with evidence of ocular disease such as meibomian gland disease, herpetic keratitis, uveitis, glaucoma, visually significant cataract, retinal diseases like retinal dystrophies or diabetic retinopathy, progressive/unstable myopia or astigmatism, corneal dystrophies, keratoconus, any history of corneal trauma or surgery, dry eye status(demonstrated by a Schirmer’s 2 test value of less than 10 mm), the use of any systemic medication likely to affect wound healing (e.g., corticosteroids or antimetabolites), an immunocompromised state, and patients who were pregnant or nursing mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative uncorrected visual acuity |
day 1, 15 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| contrast sensitivity, higher order aberrations. |
day 1, 15 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Until recently, femtosecond lasers have primarily been used as an alternative to microkeratomes to cut thinner and planar corneal flaps in LASIK patients.However, while these advanced laser systems replaced the mechanical microkeratome, the actual refractive procedure was performed using the 193 nm-ArF excimer laser.Today’s increasing standards of patient care demand a safer and more predictable procedure that offers better patient comfort postoperatively. With this in mind, researchers have developed the refractive lenticule extraction (ReLEx®) procedure. This procedure uses only a femtosecond laser as an all-in-one device to both create a flap and process the lenticule and has been proposed as an alternative to the LASIK process.The ReLEx® small incision lenticule extraction (SMILE) procedure is a flapless surgery, whereby the femtosecond laser cuts an intrastromal lenticule that is removed through a small incision(2-4mm).The thickness of the intrastromal lenticule corresponds to the patient’s refractive error.SMILE offers
several advantages over the current corneal refractive surgeries, including reduced
tissue removal, better biomechanical stability, no flap-related complications,and
fewer dry eye symptoms.So far, relatively little is known about the
refractive outcomes, contrast sensitivity, aberrations, and dry eyes in a large
sample size of SMILE patients. In this paper, we present our clinical experience with ReLEx®SMILE performed in 600 eyes. |