Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

• Sponsor: RxSight, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03660865
• Collaborator: (none)
• Enrollment: 105
• Locations: 6
• Arms: 2
• Actual Duration (Months): 19.1
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.

Condition or Disease	Intervention/Treatment	Phase
Aphakia; Cataract	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Device: Control IOL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.
• Masking: None (Open Label)
• Masking Description: Select post operative assessments will be performed on both the experimental and control eye by an examiner who will be masked to the eye assignments.
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
• Actual Study Start Date: Aug 28, 2018
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD) A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Primary eye will receive Light adjustable lens with Light delivery Device treatments
Active Comparator: Control IOL A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.	Device: Control IOL; Fellow eye will receive control IOL

Outcome Measures

Primary Outcome Measures

1. Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]

2. Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]

3. One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5% [Postop Month 6]

Secondary Outcome Measures

1. Uncorrected Distance Visual Acuity (UCDVA) [Postop Month 6]

2. Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination [Postop Month 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL).

• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.

• History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.

• Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.

• Willing and able to comply with the requirements for study specific procedures and visits.

• Able to complete a written questionnaire in English.

Exclusion Criteria:

• Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.

• Pre-existing macular disease in either eye.

• Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.

• History of uveitis in either eye.

• Evidence of ectasia in either eye.

• Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.

• Subjects taking systemic medication that may increase sensitivity to UV light.

• Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.

• History of ocular herpes simplex virus in either eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Discover Vision Centers	Leawood	Kansas	United States	66211
2	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141
3	Vance Thompson Vision Clinic	Sioux Falls	South Dakota	United States	57108
4	Slade & Baker Vision	Houston	Texas	United States	77027
5	Focal Point Vision	San Antonio	Texas	United States	78229
6	The Eye Institute of Utah	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• RxSight, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 3, 2019

More Information

Publications

None provided.

• Responsible Party: RxSight, Inc.
• ClinicalTrials.gov Identifier: NCT03660865
• Other Study ID Numbers: CSP-027
• First Posted: Sep 7, 2018
• Last Update Posted: Dec 23, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by RxSight, Inc.: Light Adjustable Lens; Intraocular lens; LAL
• Additional relevant MeSH terms: Cataract; Aphakia

Study Results

Participant Flow

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Control IOL
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL
Period Title: Overall Study
STARTED	105	105
COMPLETED	105	105
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Control IOL	Total
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL	Total of all reporting groups
Overall Participants	105	105	210
Overall Eyes	105	105	210
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.2 (6.9)	64.2 (6.9)	64.2 (6.9)
Sex: Female, Male (Eyes) [Count of Units]
Female	60	60	120
Male	45	45	90
Ethnicity (NIH/OMB) (Eyes) [Count of Units]
Hispanic or Latino	12	12	24
Not Hispanic or Latino	93	93	186
Unknown or Not Reported	0	0	0
Race (NIH/OMB) (Eyes) [Count of Units]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	105	105	210
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment (Eyes) [Number]
United States	105	105	210
Eye (Eyes) [Count of Units]
OD Eye	52	53	105
OS Eye	53	52	105

Outcome Measures

1. Primary Outcome

Title	Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time Frame	Postop Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Control IOL
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL
Measure Participants	105	105
Measure Eyes	105	105
Mean (Standard Deviation) [Diopter]	-0.319 (0.319)	-0.452 (0.456)

2. Primary Outcome

Title	Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time Frame	Postop Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Control IOL
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL
Measure Participants	105	105
Measure Eyes	105	105
Mean (Standard Deviation) [Diopter]	0.269 (0.269)	0.379 (0.338)

3. Primary Outcome

Title	One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Time Frame	Postop Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
Measure Participants	105
Measure Eyes	105
Number (95% Confidence Interval) [percent of eyes w. BCDVA 20/40 or better]	100

4. Secondary Outcome

Title	Uncorrected Distance Visual Acuity (UCDVA)
Time Frame	Postop Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Control IOL
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL
Measure Participants	105	105
Measure Eyes	105	105
Mean (Standard Deviation) [logMAR]	0.002 (0.108)	0.052 (0.130)

5. Secondary Outcome

Title	Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Time Frame	Postop Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Control IOL
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL
Measure Participants	42	42
Measure Eyes	42	42
Mean (Standard Deviation) [mean logMAR UCDVA]	-0.003 (0.113)	0.061 (0.139)

Adverse Events

Time Frame	Through study completion, an average of 6 months
Adverse Event Reporting Description	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.
Arm/Group Title	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)		Control IOL
Arm/Group Description	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments		A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL
All Cause Mortality
	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)		Control IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/105 (0%)
Serious Adverse Events
	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)		Control IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/105 (1%)		0/105 (0%)
Eye disorders
Clinically significant Cystoid Macular Edema	0/105 (0%)	0	0/105 (0%)	0
Secondary Surgical Intervention (excluding Posterior Capsulotomy)	1/105 (1%)	1	0/105 (0%)	0
Other (Not Including Serious) Adverse Events
	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)		Control IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/105 (45.7%)		38/105 (36.2%)
Eye disorders
Anterior Chamber Inflammation	2/105 (1.9%)	2	2/105 (1.9%)	2
Corneal Edema	2/105 (1.9%)	2	0/105 (0%)	0
Loss of BCDVA of >/= 10 letters (when compared to Preoperative or Postop Week 3 BCDVA)	1/105 (1%)	1	0/105 (0%)	0
Removal of retained Cortex	0/105 (0%)	0	1/105 (1%)	1
Conjunctival hyperemia	1/105 (1%)	1	0/105 (0%)	0
Conjunctival hyperemia/edema	1/105 (1%)	1	1/105 (1%)	1
Corneal SPK	1/105 (1%)	1	0/105 (0%)	0
Double vision	1/105 (1%)	1	1/105 (1%)	1
Epiretinal membrane	0/105 (0%)	0	1/105 (1%)	1
Epithelial basement membrane dystrophy appearance	1/105 (1%)	1	0/105 (0%)	0
Epithelial defect	0/105 (0%)	0	2/105 (1.9%)	2
Glare at night	0/105 (0%)	0	1/105 (1%)	1
Iris atrophy/Medication deposits	1/105 (1%)	1	0/105 (0%)	0
Iris prolapse	1/105 (1%)	1	0/105 (0%)	0
Light sensitivity	2/105 (1.9%)	2	2/105 (1.9%)	2
Non-clinically significant cystoid macular edema	0/105 (0%)	0	1/105 (1%)	1
Ocular discomfort	3/105 (2.9%)	3	1/105 (1%)	1
Posterior vitreous detachment	0/105 (0%)	0	1/105 (1%)	1
Retained cortex	0/105 (0%)	0	1/105 (1%)	1
Vision doesn't fuse together for distance well	1/105 (1%)	1	0/105 (0%)	0
Vitreous hemorrhage	0/105 (0%)	0	1/105 (1%)	1
Vitreous in anterior chamber	0/105 (0%)	0	1/105 (1%)	1
YAG performed to treat capsular phemosis	1/105 (1%)	1	0/105 (0%)	0
YAG performed to treat capsular striae	1/105 (1%)	1	0/105 (0%)	0
YAG performed to treat posterior capsular opacity	27/105 (25.7%)	27	20/105 (19%)	20
YAG performed to treat vitreous strand	1/105 (1%)	1	1/105 (1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.