A Cataract Surgery Clinical Trial

Alcon

Status: Not yet enrolling

Conditions: Cataract

Treatments: Device: CENTURION Vision System with Active Sentry; Device: UNITY Vitreoretinal Cataract System; Procedure: Anterior segment ophthalmic surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT07044674

CTV678-P002

Details and patient eligibility

About

The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.

Full description

In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Clinically documented diagnosis of age-related nuclear sclerotic cataract of grade 2 or greater in both eyes;
• Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade);
• Both eyes able to be implanted with same intraocular lens material;
• Both eyes able to receive the same ophthalmic viscosurgical device (OVD).
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Planned intraoperative glaucoma surgery or expected postoperative procedures during the study in either study eye;
• Laser-assisted cataract surgery in either study eye;
• Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in 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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125 participants in 2 patient groups

UNITY Vitreoretinal Cataract System (VCS)

Experimental group

Description:

Anterior segment ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)

Treatment:

Procedure: Anterior segment ophthalmic surgery

Device: UNITY Vitreoretinal Cataract System

CENTURION Vision System with Active Sentry (CAS)

Active Comparator group

Description:

Anterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS)

Treatment:

Procedure: Anterior segment ophthalmic surgery

Device: CENTURION Vision System with Active Sentry