Trial Outcomes & Findings for Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes (NCT NCT04529616)

NCT ID: NCT04529616

Last Updated: 2025-02-10

Results Overview

Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

• Recruitment status: COMPLETED
• Target enrollment: 79 participants
• Primary outcome timeframe: 3 months post op
• Results posted on: 2025-02-10

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Overall Study STARTED	79 141
Overall Study COMPLETED	79 141
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

Baseline characteristics by cohort

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=79 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Age, Continuous	66.6 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	20 Participants n=5 Participants
Region of Enrollment Mexico	79 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post op

Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

Outcome measures

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=32 Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better	21 Eyes

PRIMARY outcome

Timeframe: 12 months post op

Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment

Outcome measures

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=95 Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better	91 Eyes

Adverse Events

Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=79 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Cardiac disorders Cardiogenic Shock	1.3% 1/79 • Number of events 1 • 12 months
Vascular disorders Blood clots secondary to head trauma from a fall	1.3% 1/79 • Number of events 1 • 12 months

Other adverse events

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=79 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Eye disorders Intraretinal microhemorrhage secondary to diabetes and hypertension	1.3% 1/79 • Number of events 1 • 12 months
Eye disorders Microaneurism, intraretinal hemorrhage dots secondary to history of diabetes	1.3% 1/79 • Number of events 1 • 12 months
Eye disorders Corneal epithelium: epithelialized with SPK	1.3% 1/79 • Number of events 2 • 12 months
Eye disorders Granular deposits over IOL	1.3% 1/79 • Number of events 2 • 12 months
Eye disorders Epiretinal membrane	3.8% 3/79 • Number of events 4 • 12 months
Eye disorders Drusen	2.5% 2/79 • Number of events 4 • 12 months
Eye disorders Pigmentary changes	1.3% 1/79 • Number of events 1 • 12 months
Nervous system disorders Optic nerve edema secondary to head trauma	1.3% 1/79 • Number of events 1 • 12 months
Eye disorders Posterior capsular opacity	1.3% 1/79 • Number of events 1 • 12 months

Additional Information

Associate Director, Clinical Trials

RxSight, Inc.

Phone: 9494215463

Email: dgoffredo@rxsight.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place