An interventional study of UNITY Vitreoretinal Cataract System (VCS) and CONSTELLATION Vision System in Epiretinal Membrane, Macular Hole and Visually Significant Vitreous Floater, sponsored by Alcon Research. Withdrawn at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.
130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.
Browse Epiretinal Membrane studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)
Device: UNITY Vitreoretinal Cataract System (VCS) · Procedure: Vitreoretinal ophthalmic surgery
Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System
Device: CONSTELLATION Vision System · Procedure: Vitreoretinal ophthalmic surgery
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery.
CONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding.
Ophthalmic surgery performed in the posterior segment of the eye
Percentage of vitreoretinal surgeries performed using 27-gauge consumables
The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery
Time frame: Day 0 operative
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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