Cataract
Conditions
Keywords
Anterior segment ophthalmic 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 user preference data.
Detailed description
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.
Interventions
PROCEDUREAnterior segment ophthalmic surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
DEVICEUNITY VCS
UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand and sign an IRB/IEC approved Informed Consent form. * Willing and able to attend all scheduled visits as required by the protocol. * Clinically documented diagnosis of age-related noncomplicated cataract. * Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Women of childbearing potential as defined in the protocol. * Planned postoperative procedures during the course of the study in the operative eye. * Previous intraocular or corneal surgery in the operative eye. * Diagnosis of glaucoma or ocular hypertension (IOP \> 21 mmHg) in the operative eye. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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? | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Incision Entry to Incision Closure | Day 0 surgery | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 4 investigative sites located in the United States.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| UNITY VCS Anterior segment ophthalmic surgery performed with UNITY VCS | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-ocular and non-device related adverse event | 1 |
Baseline characteristics
| Characteristic | UNITY VCS |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 6.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 61 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 104 Participants |
| Region of Enrollment United States | 108 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 108 | 0 / 108 |
| other Total, other adverse events | 0 / 108 | 0 / 108 | 0 / 108 |
| serious Total, serious adverse events | 0 / 108 | 2 / 108 | 3 / 108 |
Outcome results
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.
Time frame: Day 0
Population: All Implanted Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UNITY VCS | 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? | 99.1 percentage of responses |
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.
Time frame: Day 0 surgery
Population: All Implanted Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UNITY VCS | Time From Incision Entry to Incision Closure | 376.8 seconds | Standard Deviation 117.22 |