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

Visual and Refractive Outcomes with ReLEx® SMILE in 600 Eyes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/01/005472
Enrollment
300
Registered
2015-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- myopia

Interventions

Intervention1: RELEX SMILE : surgical procedure to correct myopia comparator agent : not applicable: patients undergoing surgery for correction of myopia underwent a thorough pre-operative evaluation

Sponsors

Nethradhama Superspeciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
postoperative uncorrected visual acuityTimepoint: day 1, 15 3 months, 6 months

Secondary

MeasureTime frame
contrast sensitivity, higher order aberrations.Timepoint: day 1, 15 3 months, 6 months

Countries

India

Contacts

Public ContactRishika Gupta

Nethradhama SuperSpeciality Eye Hospital

rishikagupta55@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026