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RECRUITINGOBSERVATIONAL

Surgical Procedure Efficiency Evaluation stuDy

Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Key Who May Qualify: - Able to understand and sign an willing to sign a consent form 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 Who Should NOT Join This Trial: - Unplanned/emergency phacovitrectomy. - Pregnant. - Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye. - Other protocol-defined exclusion criteria may apply. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

UNITY VCS

UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).

DEVICE

CONSTELLATION

CONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).

Locations (1)

Manchester Royal Eye Hospital
Manchester, United Kingdom