Trial Outcomes & Findings for Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism (NCT NCT03771352)

NCT ID: NCT03771352

Last Updated: 2021-06-09

Results Overview

Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

at 6 months postop

Results posted on

2021-06-09

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	RxSight RxLAL IOL Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Overall Study STARTED	55 110
Overall Study COMPLETED	51 101
Overall Study NOT COMPLETED	4 9

Reasons for withdrawal

Reasons for withdrawal
Measure	RxSight RxLAL IOL Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Overall Study Screen failure	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

"Primary eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RxSight RxLAL IOL n=101 Eyes Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Age, Continuous	68.4 years STANDARD_DEVIATION 9.7 • n=51 Participants
Sex: Female, Male Female	26 Participants n=51 Participants
Sex: Female, Male Male	25 Participants n=51 Participants
Race/Ethnicity, Customized Asian	0 participants n=51 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=51 Participants
Race/Ethnicity, Customized White	51 participants n=51 Participants
Region of Enrollment United Kingdom	8 participants n=51 Participants
Region of Enrollment Germany	43 participants n=51 Participants
Primary Eyes Enrolled OD	26 Eyes n=51 Eyes • "Primary eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories
Primary Eyes Enrolled OS	25 Eyes n=51 Eyes • "Primary eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories
Fellow Eyes Enrolled OD	24 Eyes n=50 Eyes • "Fellow eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories
Fellow Eyes Enrolled OS	26 Eyes n=50 Eyes • "Fellow eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories

PRIMARY outcome

Timeframe: at 6 months postop

Population: A modified Effectiveness (m-Effectiveness) population was used for all effectiveness analyses which includes all observed data without treatment related protocol deviations.

Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better

Outcome measures

Outcome measures
Measure	RxSight RxLAL IOL n=59 Eyes Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better	45 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 6 months

Population: Safety population

Number of study eyes experiencing Ocular adverse events (device related and unrelated)

Outcome measures

Outcome measures
Measure	RxSight RxLAL IOL n=101 Eyes Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)	3 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 6 months

Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.

Outcome measures

Outcome measures
Measure	RxSight RxLAL IOL n=101 Eyes Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Number of Eyes That Received Secondary Surgical Interventions (SSIs)	1 Eyes

Adverse Events

RxSight RxLAL IOL

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RxSight RxLAL IOL n=101 participants at risk Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Surgical and medical procedures IOL Explant	0.99% 1/101 • Number of events 1 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Gastrointestinal disorders Gastritis with diarrhea	2.0% 1/51 • Number of events 1 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.

Other adverse events

Other adverse events
Measure	RxSight RxLAL IOL n=101 participants at risk Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Eye disorders Loss of BSCVA of ≥ 10 letters due to dry Eye	2.0% 2/101 • Number of events 2 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Clinically significant cystoid macular edema	2.0% 2/101 • Number of events 2 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Corneal Edema	0.99% 1/101 • Number of events 1 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Blurred vision right eye	0.99% 1/101 • Number of events 1 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Conjunctivitis	2.0% 2/101 • Number of events 2 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Cornea Epithelialized with SPK	2.0% 2/101 • Number of events 2 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Diabetic macular edema	3.0% 3/101 • Number of events 3 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Increased protein distribution after lock-in procedure	0.99% 1/101 • Number of events 1 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Giant cells on anterior surface of IOL	2.0% 2/101 • Number of events 2 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Non-clinically significant cystoid macular edema	5.9% 6/101 • Number of events 6 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Posterior Capsular Opacity	3.0% 3/101 • Number of events 3 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Loss of BCDVA due to Posterior Capsular Opacity	2.0% 2/101 • Number of events 2 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Eye disorders Loss of BCDVA due to lens aberrations	0.99% 1/101 • Number of events 1 • Through study completion, an average of 6 months Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.

Additional Information

Jeffrey Ha, Senior Director of Clinical Research

RxSight

Phone: 949-521-7870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place