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The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.
Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated. This study will be conducted in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNITY VCS | Experimental | Anterior segment ophthalmic surgery performed with UNITY VCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior segment ophthalmic surgery | Procedure | Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?" | As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate management of fluid as well as removal, cutting, and coagulation of ocular materials. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Incision Entry to Incision Closure | The time from incision entry to incision closure was measured using a stopwatch and recorded in seconds. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Day 0 surgery |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CRD Surgical | Alcon Research, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center | San Diego | California | 92122 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41710169 | Derived | Berdahl J, Terveen D, Aboughaida A, Dyk DW, Yalamanchili S, Makari S, Thompson V. Bench Evaluation of Intraocular Pressure Control with Clinical Assessment of Anterior Chamber Stability of a Dual Peristaltic Phacoemulsification Device. Clin Ophthalmol. 2026 Feb 11;20:570189. doi: 10.2147/OPTH.S570189. eCollection 2026. |
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Of the 121 participants enrolled in the study, 13 were exited prior to attempted treatment. This reporting group includes all participants with attempted treatment (108).
Participants were recruited from 4 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | UNITY VCS | Anterior segment ophthalmic surgery performed with UNITY VCS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: All eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye)
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| ID | Title | Description |
|---|---|---|
| BG000 | UNITY VCS | Anterior segment ophthalmic surgery performed with UNITY VCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?" | As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate management of fluid as well as removal, cutting, and coagulation of ocular materials. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | All Implanted Analysis Set | Posted | Number | 95% Confidence Interval | percentage of responses | Day 0 | eyes | eyes |
|
Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 3 months.
AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | AEs in this group occurred prior to treatment with UNITY VCS | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA (26.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Principal Clinical Project Lead, Surgical | Alcon Research LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2023 | May 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2023 | May 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| UNITY VCS | Device | UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit |
|
| Miramar Eye Specialists Medical Group |
| Ventura |
| California |
| 93003 |
| United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Secondary | Time From Incision Entry to Incision Closure | The time from incision entry to incision closure was measured using a stopwatch and recorded in seconds. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | All Implanted Analysis Set | Posted | Mean | Standard Deviation | seconds | Day 0 surgery | eyes | eyes |
|
|
|
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | UNITYVCSstudyeye | AEs in this group occurred after attempted treatment with with UNITY VCS and include ocular events in the study eye. "At Risk" population is reported in units of eyes. | 0 | 108 | 2 | 108 | 0 | 108 |
| EG002 | UNITYVCSSystemic | AEs in this group occurred after attempted treatment with UNITY VCS and include overall systemic events as well as ocular events in the non-study eye. "At Risk" population is reported in units of subjects. | 0 | 108 | 3 | 108 | 0 | 108 |
| Cellulitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
|
| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (26.1) | Systematic Assessment |
|
| Lens extraction | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.