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Comparison of two refractive surgery techniques ReLEx SMILE and PRK for the correction of low degrees of short sightedness

Comparison of ReLEx SMILE and PRK in terms of visual and refractive outcomes and patient satisfaction for the correction of low myopia - SMILE VS PRK

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005084
Enrollment
60
Registered
2014-10-08
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- Patients with low degrees of myopia (Spherical equivalent of -4D)

Interventions

Intervention1: ReLEx SMILE (Refractive Lenticule Extraction, Small Incision Lenticule Extraction): Under topical anaesthesia, VisuMax femtosecond laser (Carl Zeiss Meditec AG) will be used for the sma
the cornea washed with Balanced Salt Solution (BSS). The loose epithelium is then removed as a sheet by lifting the edge of the loosened epithelium with shar

Sponsors

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Myopia with SEQ •Stable corneal conditions within the last 12 months •Stable refraction since 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

Exclusion criteria: •Thin corneas (Corneal pachymetry •Steep corneas Kmax >48 D •Keratoconus suspects or frank keratoconus •Mixed astigmatism •Moderate to severe dry eye (Shirmers1 •Socket / globe /lid anomalies â?? very deep set eyes, nanophthalmos •Severe meibomian gland disease, lid abnormalities •Severe atopy •Contact lens overuse •Pregnant and nursing mother •Autoimmune disorders •Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants.

Design outcomes

Primary

MeasureTime frame
Matched population comparison of refractive and visual outcomes and patient satisfaction between ReLEx SMILE and PRK for the correction of low myopia (SEQ 4D)Timepoint: 6 months

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDR SRI GANESH

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL

utsav_5093@yahoo.com09901903149

Outcome results

None listed

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