Trial Outcomes & Findings for A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL) (NCT NCT04005586)

NCT ID: NCT04005586

Last Updated: 2021-06-11

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Post Op Month 3

Results posted on

2021-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Light Delivery Device (LDD) Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Light Delivery Device (LDD) n=25 Participants Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments
Age, Continuous	67.2 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Post Op Month 3

Outcome measures

Outcome measures
Measure	Light Delivery Device (LDD) n=25 Participants Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups	-0.14 Diopter (D) Standard Deviation 0.21

PRIMARY outcome

Timeframe: Post Op Month 3

Outcome measures

Outcome measures
Measure	Light Delivery Device (LDD) n=25 Participants Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups	0.36 Diopter (D) Standard Deviation 0.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 3 months

Population: Safety population

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

Outcome measures

Outcome measures
Measure	Light Delivery Device (LDD) n=25 Participants Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments
Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated)	4 eyes

Adverse Events

Light Delivery Device (LDD)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Light Delivery Device (LDD) n=25 participants at risk Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments
Eye disorders Non-clinically significant cystoid macular edema	4.0% 1/25 • Number of events 1 • Through study completion, an average of 3 months. Non-ocular adverse events were not collected. Adverse events were counted by eye.
Eye disorders Non-clinically significant cystoid macular edema in non-study eye	4.0% 1/25 • Number of events 1 • Through study completion, an average of 3 months. Non-ocular adverse events were not collected. Adverse events were counted by eye.
Eye disorders Posterior Capsular Opacity (PCO) that requires YAG Capsulotomy treatment	12.0% 3/25 • Number of events 3 • Through study completion, an average of 3 months. Non-ocular adverse events were not collected. Adverse events were counted by eye.

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