CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
Tobramycin and dexamethasone +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02528123
NCT02528123N/ACompleted
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VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia

London Vision Clinic·interventional·Posted Aug 19, 2015·Updated Apr 23, 2024

In Brief

A clinical study evaluating Small incision lenticule extraction, Tobramycin and dexamethasone, and 3 other interventions for Myopia and Refractive Errors. Completed, enrolled 114 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyopia, Refractive Errors
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 19, 2015
Enrollment StartApr 1, 2016
Primary CompletionDec 7, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.9 years ago

Interventions

Small incision lenticule extractionprocedure

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.

Tobramycin and dexamethasonedrug

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

Ofloxacindrug

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

Proxymetacaine 0.5%drug

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

Oxybuprocaine 0.4%drug

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