Trial Outcomes & Findings for A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus (NCT NCT04177771)

Last Updated: 2025-01-07

Results Overview

Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group.

Recruitment status

TERMINATED

Target enrollment

34 participants

Primary outcome timeframe

Postop Month 6

Results posted on

2025-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL Tecnis ZCB00/ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Pre-COVID Population STARTED	10	7	0	0
Pre-COVID Population COMPLETED	10	7	0	0
Pre-COVID Population NOT COMPLETED	0	0	0	0
Modified Safety Population STARTED	0	0	7	10
Modified Safety Population COMPLETED	0	0	7	10
Modified Safety Population NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 Participants Tecnis ZCB00/ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n=7 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL n=10 Participants SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL	Total n=34 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 8.7 • n=5 Participants	69.2 years STANDARD_DEVIATION 5.5 • n=7 Participants	65.4 years STANDARD_DEVIATION 8.5 • n=5 Participants	66.6 years STANDARD_DEVIATION 5.5 • n=4 Participants	66.4 years STANDARD_DEVIATION 7.3 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Caucasian	9 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	33 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black/African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian/Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian/Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Postop Month 6

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 Primary Eyes Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n=7 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL n=10 Primary Eyes SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group	2.30 Diopters	0.97 Diopters	1.58 Diopters	0.85 Diopters

PRIMARY outcome

Timeframe: Postop Month 6

Population: Since the sample sizes of each group did not meet the minimum requirements (8 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups.

Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 Primary Eyes Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n=7 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL n=10 Primary Eyes SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group	0.09 LogMAR Interval -0.02 to 0.19	0.29 LogMAR Interval 0.13 to 0.44	0.13 LogMAR Interval 0.01 to 0.26	0.33 LogMAR Interval 0.21 to 0.46

PRIMARY outcome

Timeframe: 6 months

Population: Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled (Light adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID population and TECNIS ZCB00 or ZTC150 IOL) may have been delayed outside protocol specified windows or missed completely. Since the sample sizes of each group did not meet the minimum requirements (28 eyes per lens group) for statistical power per study protocol, 95% confidence intervals were calculated.

Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 Primary Eyes Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6	80 percentage of Primary Eyes Interval 44.4 to 97.5	71.4 percentage of Primary Eyes Interval 29.0 to 96.3	—	—

PRIMARY outcome

Timeframe: Postop Month 6

Population: Since the sample sizes of each group did not meet the minimum requirements (42 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups.

Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 Primary Eyes Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n=7 Primary Eyes Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL n=10 Primary Eyes SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group	0.00 LogMAR Interval -0.08 to 0.09	-0.11 LogMAR Interval -0.16 to -0.05	0.02 LogMAR Interval -0.09 to 0.12	-0.06 LogMAR Interval -0.13 to 0.01

Adverse Events

Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Tecnis ZCB00 or ZTC150 IOL

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

SofPort LI61AO IOL

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 participants at risk Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n=7 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL n=10 participants at risk SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Hepatobiliary disorders Gall bladder removal	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	14.3% 1/7 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Cardiac disorders Acute coronary syndrome	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	10.0% 1/10 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Hepatobiliary disorders Laparoscopic cholecystectomy for gall stones	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	14.3% 1/7 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Skin and subcutaneous tissue disorders Internal and external hemorrhoids requiring hospitalization	10.0% 1/10 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.

Other adverse events

Other adverse events
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n=10 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Tecnis ZCB00 or ZTC150 IOL n=7 participants at risk Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n=7 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	SofPort LI61AO IOL n=10 participants at risk SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL
Eye disorders Primary and Fellow Eye, BCDVA letter drop 10 letters or worse compared to week 3	50.0% 5/10 • Number of events 8 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	14.3% 1/7 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	42.9% 3/7 • Number of events 5 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Posterior capsular opacity requiring YAG	50.0% 5/10 • Number of events 8 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	14.3% 1/7 • Number of events 2 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	42.9% 3/7 • Number of events 5 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	10.0% 1/10 • Number of events 2 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Non-clinically significant cystoid macular edema	10.0% 1/10 • Number of events 2 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Punctate Epithelial Erosion causing watery and uncomfortable eye	10.0% 1/10 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Subjective symptom of blurry vision, red in lights and starbursts	10.0% 1/10 • Number of events 2 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Subjective symptom of much less crisp vision	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	14.3% 1/7 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Glare or halos or double/multiple images	10.0% 1/10 • Number of events 2 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Drusen	10.0% 1/10 • Number of events 2 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
Eye disorders Primary and Fellow Eye, Cellulitis, hordeolum	10.0% 1/10 • Number of events 1 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/7 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.	0.00% 0/10 • 6 months Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.

Additional Information

Jeffrey Ha, VP Clinical Affairs

RxSight

Phone: 949-521-7870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place