NCT02528123

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: London Vision Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

Laser refractive surgery (LASIK and PRK) has been established for 25 years to treat myopia (short-sightedness). Over this time, the technology has been significantly improved to enable safe treatment of myopia up to -15D. Improvements including changing the shape of the lens of corneal tissue removed to better match the natural shape, and increasing the diameter of the applied correction to cover larger pupil sizes, have greatly reduced side-effects such as night vision glare and halos. Similarly, safety has been improved by using a laser (femtosecond laser) to create the corneal flap rather than a blade (known as a microkeratome), meaning that the cornea is reliably left with more than the safe amount of tissue. In 2006, a new method of laser refractive surgery was introduced, small incision lenticule extraction (SMILE), which provides a minimally invasive keyhole method as it avoids the need to create a flap. In SMILE, a single laser (femtosecond laser) is used to make two curved cuts inside the cornea (without breaching the outside) that separate the lens of tissue that needs removing to focus the vision. This lens of tissue is removed in once piece (rather than evaporated as in LASIK) through a small 2mm wide tunnel to the surface. SMILE has been used to treat short-sightedness up to -10D for more than 200,000 procedures worldwide and has been shown to achieve similar results to LASIK. However, because no flap is needed, this upper part of the cornea can also contribute strength, meaning that the cornea is stronger after SMILE than after LASIK. It is also expected that the accuracy for higher corrections using SMILE would be better than LASIK because the potential inaccuracies associated with excimer lasers (used in LASIK) are eliminated. This study will investigate the results of SMILE for myopia above -10D.

Conditions

• Myopia
• Refractive Errors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-12-07
• Completion: 2020-12-07
• First posted: 2015-08-19
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

1 site across 1 country: United Kingdom