Clinical Evaluation of FLACS with Combination of LenSx and Centurion

JRCT ID: jRCTs072180023

Registered date:22/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 22/08/2018
• Target sample size: 55
• Study type: Interventional

Intervention(s)

-FLACS
Femtosecond laser assisted cataract surgery consisting of LenSx and Centurion combination
-CENTURION Vision System
Phacoemulsification aspiration platform for use
during cataract surgery

LenSx:
- FLACS in 1 eye, with manual conventional surgery in the fellow eye, as randomized.
- Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens frag mentation during cataract surgery

Conventional:
-Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized
-Manual conventional surgery
Removal of cataractous lens by phacoemulsification
-CENTURION Vision System
Phacoemulsification aspiration platform for use
during cataract surgery

Outcome(s)

Primary Outcome

CDE (Cumulative Dissipated Energy, the energy dissipated at the incision point during the removal of cataractous lens) will be measured.
[Time Frame: Visit 00 (Surgery day)]

Secondary Outcome

-Percent change of corneal endothelial cell density (ECD)
Specular microscopy will be performed and endothelial cell density will be recorded.
[Time Frame: Visit 5 (Day 150-210 post-surgery)]

-Average torsional amplitude
Torsional amplitude will be recorded by Centurion and measured as a percentage.
[Time Frame: Visit 00 (Surgery day)]

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes
2.Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
3.Calculated lens power within the available range
4.Other protocol-specified inclusion criteria may apply.

Exclude criteria

1.Any pathology that could reduce visual potential
2.Hypotony or the presence of a corneal implant
3.Residual, recurrent, active ocular or eyelid disease
4.Poorly dilating pupil
5.Any contraindication to cataract
6.Eyes with two different levels of cataract grade
7.Pregnant, or planned pregnancy during the study
8.Expected to require an ocular surgical treatment at any time during the study
9.Other protocol-specified exclusion criteria may apply

Related Information

• Primary Sponsor: Oka Yoshitaka
• Source(s) of Monetary Support: Alcon Japan Ltd.
• Secondary ID(s): NCT03479944,UMIN000031996