Trial Outcomes & Findings for Next Generation Cataract Surgery Study (NCT NCT06071104)

Last Updated: 2025-06-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

121 participants

Primary outcome timeframe

Day 0

Results posted on

2025-06-04

Participant Flow

Participants were recruited from 4 investigative sites located in the United States.

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).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	UNITY VCS Anterior segment ophthalmic surgery performed with UNITY VCS
Overall Study STARTED	108 108
Overall Study COMPLETED	107 107
Overall Study NOT COMPLETED	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	UNITY VCS Anterior segment ophthalmic surgery performed with UNITY VCS
Overall Study Non-ocular and non-device related adverse event	1

Baseline Characteristics

Next Generation Cataract Surgery Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UNITY VCS n=108 Participants Anterior segment ophthalmic surgery performed with UNITY VCS
Age, Continuous	68.4 years STANDARD_DEVIATION 6.92 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	61 Participants n=5 Participants
Race/Ethnicity, Customized White	104 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Region of Enrollment United States	108 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Population: All Implanted Analysis Set

Outcome measures

Outcome measures
Measure	UNITY VCS n=107 eyes Anterior segment ophthalmic surgery performed with 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 Interval 94.9 to 100.0

SECONDARY outcome

Timeframe: Day 0 surgery

Population: All Implanted Analysis Set

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.

Outcome measures

Outcome measures
Measure	UNITY VCS n=107 eyes Anterior segment ophthalmic surgery performed with UNITY VCS
Time From Incision Entry to Incision Closure	376.8 seconds Standard Deviation 117.22

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UNITYVCSstudyeye

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

UNITYVCSSystemic

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=108 participants at risk AEs in this group occurred prior to treatment with UNITY VCS	UNITYVCSstudyeye n=108 participants at risk 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.	UNITYVCSSystemic n=108 participants at risk 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.
Eye disorders Retinal detachment	0.00% 0/108 • 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.	0.00% 0/108 • 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.	0.93% 1/108 • Number of events 1 • 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.
Infections and infestations Cellulitis	0.00% 0/108 • 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.	0.00% 0/108 • 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.	0.93% 1/108 • Number of events 1 • 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.
Infections and infestations Pneumonia streptococcal	0.00% 0/108 • 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.	0.00% 0/108 • 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.	0.93% 1/108 • Number of events 1 • 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.
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/108 • 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.	0.93% 1/108 • Number of events 1 • 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.	0.93% 1/108 • Number of events 1 • 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.
Investigations Intraocular pressure increased	0.00% 0/108 • 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.	0.93% 1/108 • Number of events 1 • 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.	0.00% 0/108 • 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.
Surgical and medical procedures Lens extraction	0.00% 0/108 • 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.	0.93% 1/108 • Number of events 1 • 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.	0.00% 0/108 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Sr. Principal Clinical Project Lead, Surgical

Alcon Research LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER