Posters

Femtosecond intracorneal tunnel application with novel Femton F1

Poster Details

First Author: P.M INDIA

Co Author(s):    J. Kumar Reddy                    

Abstract Details

Purpose:

This clinical study was focused on creating intracorneal ring tunnels and to develop a safe and repeatable procedure for the treatment of keratoconus.

Setting:

Sankara Eye Hospital, Coimbatore.

Methods:

•Femton F1 (Excelsius Medical Co., Ltd., Tainan, Taiwan) is an innovative method, it uses algorithms to guide the laser beam, which creates a series of tiny bubbles within the central layer of the cornea. •A total of 19 subjects were screened and 18 subjects were enrolled in the study. This report includes data of 32 eyes of 18 subjects of more than 18 years old. •The post operative width and depth was measured manually using the scheimpflug image obtained by Pentacam.

Results:

Efficacy Endpoints: •Primary End Point: For the tunnels’ diameter, the 5% deviation from its surgical plan is not allowed in more than 20% of cases. The study fulfils the primary endpoint as only 12.5% cases were having 5% deviation from its surgical plan for tunnel’s diameter. •Secondary End Point: For the depth of tunnels, the 10% deviation its surgical plan is not allowed in more than of 20% of cases. The study fulfills the secondary endpoint as none of the cases were having 10% deviation from its surgical plan for depth of tunnels.

Conclusions:

Considering all products, models, sizes, settings and the purpose of the device under evaluation Femton F1 is claimed to be a substantial equivalent to the marketed products. •The study fulfils the primary endpoint as only 12.5% cases were having 5% deviation from its surgical plan for tunnel’s diameter. •The study fulfils the secondary endpoint as no cases were having 10% deviation from its surgical plan for depth of tunnels. •Femtosecond Refractive Laser Femton F1 is effective in creating uniform depth intracorneal ring tunnels and it can be used as a safe and repeatable procedure for the treatment of Keratoconus.

Financial Disclosure:

research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented