Trial Outcomes & Findings for Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes (NCT NCT03895034)

NCT ID: NCT03895034

Last Updated: 2022-05-12

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 66 participants
• Primary outcome timeframe: 3 months post op
• Results posted on: 2022-05-12

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	66 111
Overall Study COMPLETED	64 109
Overall Study NOT COMPLETED	2 2

Reasons for withdrawal

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 Lost to Follow-up	2

Baseline Characteristics

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=111 Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Age, Continuous	67.4 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	66 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Region of Enrollment Mexico	66 participants n=5 Participants
Eyes OD	56 Eyes n=14 Eyes
Eyes OS	55 Eyes n=14 Eyes

PRIMARY outcome

Timeframe: 3 months post op

Outcome measures

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=109 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	101 Eyes

Adverse Events

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

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=111 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 Anterior Capsule Rupture	0.90% 1/111 • Number of events 1 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders BCDVA Drop of 10 letters of more	0.90% 1/111 • Number of events 2 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Corneal Erosion	0.90% 1/111 • Number of events 1 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Corneal Guttata	1.8% 2/111 • Number of events 2 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Cystoid Macular Edema	0.90% 1/111 • Number of events 1 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Iris Atrophy	0.90% 1/111 • Number of events 1 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Iritis	2.7% 3/111 • Number of events 4 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Posterior Capsular Opacity	1.8% 2/111 • Number of events 2 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Superficial Punctate Keratitis	9.9% 11/111 • Number of events 11 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Eye disorders Vision changes including night vision changes	1.8% 2/111 • Number of events 2 • Through study completion, an average of 3 months The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.

Additional Information

Jeffrey Ha, Senior Director of Clinical Research

RxSight

Phone: 949-521-7870

Email: jha@rxsight.com

Results disclosure agreements

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