Vitreoretinal Disease With or Without Cataracts
Conditions
Keywords
Vitreoretinal surgery, Vitreoretinal with cataract surgery
Brief summary
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.
Detailed description
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.
Interventions
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
PROCEDUREPosterior segment surgery in the operating room with or without simultaneous cataract surgery
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).
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery; * Clear media except for cataract and vitreous hemorrhage; * In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Previous vitrectomy in the operative eye aside from those requiring silicone oil removal; * Neovascular or uncontrolled glaucoma; * Planned glaucoma or postoperative surgeries during study aside from silicone oil removal; * Inadequate pupil dilation (less than 6 millimeters); * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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? | Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Time in Eye | Day 0 operative, up to surgery completion | 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. |
| Percent of 'Yes' Responses to the Binary Question, Was Anatomical Success Achieved for Intended Treatment? | Month 3 Postoperative | 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. |
| Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3 | Preoperative (Day -30 to 0), Month 3 Postoperative | 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. |
Countries
Australia
Participant flow
Recruitment details
Participants were recruited from 5 investigative sites located in Australia.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| UNITY VCS Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non device-related adverse event | 1 |
Baseline characteristics
| Characteristic | UNITY VCS |
|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 13.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 16 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 5 participants |
| Race/Ethnicity, Customized Other | 6 participants |
| Race/Ethnicity, Customized White | 91 participants |
| Region of Enrollment Australia | 118 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 118 | 0 / 118 |
| other Total, other adverse events | 0 / 118 | 21 / 118 | 1 / 118 |
| serious Total, serious adverse events | 1 / 118 | 38 / 118 | 6 / 118 |
Outcome results
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.
Time frame: Day 0
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UNITY VCS | 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? | 100 percentage of responses |
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.
Time frame: Preoperative (Day -30 to 0), Month 3 Postoperative
Population: Full Analysis Set with numerical Snellen values at both Preoperative and Month 3 visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UNITY VCS | Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3 | 0.186 decimal | Standard Deviation 0.241 |
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.
Time frame: Day 0 operative, up to surgery completion
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UNITY VCS | Mean Total Time in Eye | 22.788 minutes | Standard Deviation 11.5663 |
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.
Time frame: Month 3 Postoperative
Population: Full Analysis Set with data at Month 3 visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UNITY VCS | Percent of 'Yes' Responses to the Binary Question, Was Anatomical Success Achieved for Intended Treatment? | 96.6 percentage of responses |