Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: LenSx®; Procedure: Manual conventional surgery; Device: CENTURION® Vision System; Procedure: FLACS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03479944

CTB258-P001

Details and patient eligibility

About

The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.

Full description

Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.

Enrollment: 57 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

FLACS

Experimental group

Description:

Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized

Treatment:

Device: LenSx®

Procedure: FLACS

Device: CENTURION® Vision System

Conventional

Active Comparator group

Description:

Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized

Treatment:

Device: CENTURION® Vision System

Procedure: Manual conventional surgery