Study of changes in posterior surface of cornea following a refractive surgical procedure ReLEx SMILE

Not Applicable

• Conditions: Health Condition 1: null- Patients with myopia who underwent ReLEx SMILE procedure

• Registration Number: CTRI/2014/10/005083
• Lead Sponsor: ETHRADHAMA SUPERSPECIALITY EYE HOSPITA

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: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

•Any gender, 21 to 40 years of age

•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

Exclusion Criteria

•Age less than 21 or more than 40 years.

•Thin corneas (Corneal pachymetry <480u)

•Steep corneas Kmax >48 D

•Keratoconus suspects or frank keratoconus

•Mixed astigmatism

•Irregular astigmatism (e.g. Keratoconus, Pallucid Marginal Degeneration etc.)

•Moderate to severe dry eye (Shirmers1 <10 mm)

•Socket / globe /lid anomalies â?? very deep set eyes, nanophthalmos

•Severe meibomian gland disease, lid abnormalities

•Severe atopy

•Contact lens overuse

•Severe Contact lens induced ocular allergy

•Pregnant and nursing mother

•Autoimmune disorders

•Pts on systemic medications e.g. Iso retinoic acid, hormonal preparations, OCPs, antidepressants.

•ACD (endo) < 3 mm

•Cataract or glaucoma

•Pseudophakia/ Aphakia

•Abnormal endothelial cell count

•Irido- corneal angles less than Grade III

•Posterior segment disorders (e.g. Retinal degenerations, macular pathology, optic nerve atrophy, or hereditary retinal disorders)

•Corneal dystrophies/ corneal degenerations/ Corneal scarring

•Congenital ocular anomalies â?? Aniridia, Iris coloboma, microcornea, nanophthalmos

•Amblyopia

•Pseudoexfoliation Syndrome; Uveitis

•Previous intraocular and corneal surgery

•Glaucoma or IOP higher than 24mmHg

•Prior use of long term antiglaucoma or steroid medications

•Other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 log MAR

•Any pathology or condition presenting, according to the investigator opinion, a risk for the patient

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare changes in posterior corneal curvature following ReLEx SMILE in low, moderate and high myopiaTimepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
nilTimepoint: nil