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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 formal user feedback.
Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNITY VCS | Experimental | Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNITY Vitreoretinal Cataract System | Device | UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined 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 the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Time in Eye | The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Day 0 operative, up to surgery completion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Operations Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NSW Retina Pty Ltd | Hurstville | New South Wales | 2220 | Australia | ||
| Southwest Retina |
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Of the 120 participants enrolled in the study, 2 were exited as screen failures, resulting in 118 participants treated. This reporting group includes all treated participants.
Participants were recruited from 5 investigative sites located in Australia.
| ID | Title | Description |
|---|---|---|
| FG000 | UNITY VCS | Posterior segment surgery in the operating room with or without simultaneous cataract 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 | Posterior segment surgery in the operating room with or without simultaneous cataract 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 Using Vitreoretinal or Combined 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 the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Full 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 4 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 |
|---|---|---|---|---|---|
| Cystoid macular oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | 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 | Feb 4, 2024 | May 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2024 | May 16, 2025 | SAP_001.pdf |
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|
| Posterior segment surgery in the operating room with or without simultaneous cataract surgery | Procedure | Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy). |
|
| Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?" |
As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. |
| Month 3 Postoperative |
| Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3 | Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Preoperative (Day -30 to 0), Month 3 Postoperative |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| Sydney Retina Clinic & Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Adelaide Eye & Retina Centre | Adelaide | South Australia | 5000 | Australia |
| Pennington Eye Clinic | North Adelaide | South Australia | 5006 | Australia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Total Time in Eye | The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set | Posted | Mean | Standard Deviation | minutes | Day 0 operative, up to surgery completion | eyes | eyes |
|
|
|
| Secondary | Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?" | As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at Month 3 visit | Posted | Number | 95% Confidence Interval | percentage of responses | Month 3 Postoperative | eye | eye |
|
|
|
| Secondary | Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3 | Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with numerical Snellen values at both Preoperative and Month 3 visits | Posted | Mean | Standard Deviation | decimal | Preoperative (Day -30 to 0), Month 3 Postoperative | eyes | eyes |
|
|
|
| 118 |
| 1 |
| 118 |
| 0 |
| 118 |
| EG001 | UNITY VCS Ocular - Study Eye | 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 | 118 | 38 | 118 | 21 | 118 |
| EG002 | UNITY VCS Systemic | 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 | 118 | 6 | 118 | 1 | 118 |
| Diabetic retinal oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Epiretinal membrane | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Hypotony of eye | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Iris disorder | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Pupillary block | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Retinal disorder | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Retinal oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (26.1) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (26.1) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
|
| Intra-ocular injection | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
|
| Iridotomy | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
|
| Retinal operation | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (26.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.