Surgical Procedure Efficiency Evaluation stuDy

Alcon

Status: Not yet enrolling

Conditions: Retinal Detachment; Cataract; Macular Pucker; Macular Holes; Vitreous Hemorrhage

Treatments: Device: CONSTELLATION; Device: UNITY VCS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07228091

CTV678-H003

Details and patient eligibility

About

The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.

Full description

Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee.
• Planned combined phacovitrectomy procedure at one of the selected surgical sites.
• Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools.

Key Exclusion Criteria:

• Unplanned/emergency phacovitrectomy.
• Pregnant.
• Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.
• Other protocol-defined exclusion criteria may apply.

Trial design

180 participants in 2 patient groups

UNITY VCS

Description:

Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)

Treatment:

Device: UNITY VCS

CONSTELLATION

Description:

Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)

Treatment:

Device: CONSTELLATION