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VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia

NCT02528123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-04-23

Study results available
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Summary

The purpose of this study is to validate the safety and effectiveness of treating myopia (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with the VisuMax femtosecond laser.

Conditions

  • Myopia
  • Refractive Errors

Interventions

PROCEDURE

Small incision lenticule extraction

The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.

DRUG

Tobramycin and dexamethasone

Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure

DRUG

Ofloxacin

Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure

DRUG

Proxymetacaine 0.5%

Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure

DRUG

Oxybuprocaine 0.4%

Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure

Sponsors & Collaborators

  • London Vision Clinic

    lead OTHER

Principal Investigators

  • Dan Z Reinstein, MD MA · London Vision Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-12-07
Completion
2020-12-07

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528123 on ClinicalTrials.gov