NCT02528123 - VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia | Biotech Hunter

Enrollment

114

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 7, 2020

Study Completion Date

December 7, 2020

Conditions

MyopiaRefractive 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

Trial Locations (1)

W1G 7LA

London Vision Clinic, London

All Listed Sponsors

lead

London Vision Clinic

OTHER