Results and Safety of a laser surgical procedure(ReLEx SMILE) to correct myopia(short sightedness)in 600 eyes

Completed

Conditions: myopia

Registration Number: CTRI/2015/01/005472

Lead Sponsor: Nethradhama Superspeciality Eye Hospital

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.Todayâ€™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 (ReLExÂ®) 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 ReLExÂ® 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 patientâ€™s refractive error.SMILE offersseveral advantages over the current corneal refractive surgeries, including reducedtissue removal, better biomechanical stability, no flap-related complications,andfewer dry eye symptoms.So far, relatively little is known about therefractive outcomes, contrast sensitivity, aberrations, and dry eyes in a largesample size of SMILE patients. In this paper, we present our clinical experience with ReLExÂ®SMILE performed in 600 eyes.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

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 480Âµm, a residual corneal thickness of atleast 250Âµm 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.

Exclusion Criteria

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 Schirmerâ€™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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative uncorrected visual acuity	day 1, 15 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
contrast sensitivity, higher order aberrations.	day 1, 15 3 months, 6 months

Trial Locations

Locations (1): Nethradhama Superspeciality Eye Hospital
🇮🇳
Bangalore, KARNATAKA, India
Nethradhama Superspeciality Eye Hospital
🇮🇳Bangalore, KARNATAKA, India
Rishika Gupta
Principal investigator
09886309097
rishikagupta55@yahoo.com