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

Not Applicable

Completed

• Conditions: Health Condition 1: null- myopia

• Registration Number: CTRI/2015/01/005472
• Lead Sponsor: ethradhama Superspeciality Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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 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.

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