Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism

• Sponsor: RxSight, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03771352
• Collaborator: (none)
• Enrollment: 55
• Locations: 3
• Arm: 1
• Actual Duration (Months): 24.4
• Patients Per Site: 18.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: RxSight RxLAL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Multi-Center Clinical Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RxLAL) With the Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
• Actual Study Start Date: Jun 19, 2018
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: RxSight RxLAL IOL Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)	Device: RxSight RxLAL; The patients will be assessed for 6 months; Other Names: Light Adjustable Lens Light Delivery Device

Outcome Measures

Primary Outcome Measures

1. Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better [at 6 months postop]

   Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better

Other Outcome Measures

1. Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated) [Through study completion, an average of 6 months]

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

2. Number of Eyes That Received Secondary Surgical Interventions (SSIs) [Through study completion, an average of 6 months]

   Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• 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 the RxLAL.

• Greater than the age of 40 on the day the cataract surgery is performed.

• Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.

• Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.

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

Exclusion Criteria:

• Zonular laxity or dehiscence.

• Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.

• Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.

• History of uveitis

• Keratoconus or suspected of having keratoconus.

• Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.

• Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.

• Subjects taking systemic medications 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

• History of congenital color vision defect

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Eye Clinic	Bochum		Germany
2	University Eye Clinic	Heidelberg		Germany
3	Ayrshire Eye Clinic and Laser Center	Ayr	Scotland	United Kingdom

Sponsors and Collaborators

• RxSight, Inc.

Investigators

• Principal Investigator: Burkhard Dick, MD, University Eye Clinic- Bochum, Germany
• Principal Investigator: Fritz Hengerer, MD, University Eye Clinic- Heidelberg, Germany
• Principal Investigator: Sathish Srinivasan, MD, Ayrshire Eye Clinic and Laser Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: CSP-025-05 rev DE protocol and SAP 05-16-2019_Redacted - May 16, 2019
• Study Protocol and Statistical Analysis Plan: CSP-025 rev 5 UK protocol and SAP 05-16-2019_Redacted - May 16, 2019

More Information

Publications

None provided.

• Responsible Party: RxSight, Inc.
• ClinicalTrials.gov Identifier: NCT03771352
• Other Study ID Numbers: CSP-025-03
• First Posted: Dec 11, 2018
• Last Update Posted: Jun 9, 2021
• Last Verified: May 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
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by RxSight, Inc.: cataract surgery; eye disease; lenticular opacification
• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

Participant Flow

Arm/Group Title	RxSight RxLAL IOL
Arm/Group Description	Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Period Title: Overall Study
STARTED	55
COMPLETED	51
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	RxSight RxLAL IOL
Arm/Group Description	Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Overall Participants	51
Overall Eyes	101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.4 (9.7)
Sex: Female, Male (Count of Participants)
Female	26 51%
Male	25 49%
Race/Ethnicity, Customized (participants) [Number]
Asian	0 0%
Black or African American	0 0%
White	51 100%
Region of Enrollment (participants) [Number]
United Kingdom	8 15.7%
Germany	43 84.3%
Primary Eyes Enrolled (Eyes) [Count of Units]
OD	26
OS	25
Fellow Eyes Enrolled (Eyes) [Count of Units]
OD	24
OS	26

Outcome Measures

1. Primary Outcome

Title	Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Description	Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
Time Frame	at 6 months postop

Outcome Measure Data

Analysis Population Description

A modified Effectiveness (m-Effectiveness) population was used for all effectiveness analyses which includes all observed data without treatment related protocol deviations.

Arm/Group Title	RxSight RxLAL IOL
Arm/Group Description	Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Measure Participants	30
Measure Eyes	59
Count of Units [Eyes]	45

2. Other Pre-specified Outcome

Title	Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)
Description	Number of study eyes experiencing Ocular adverse events (device related and unrelated)
Time Frame	Through study completion, an average of 6 months

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	RxSight RxLAL IOL
Arm/Group Description	Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Measure Participants	51
Measure Eyes	101
Count of Units [Eyes]	3

3. Other Pre-specified Outcome

Title	Number of Eyes That Received Secondary Surgical Interventions (SSIs)
Description	Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.
Time Frame	Through study completion, an average of 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RxSight RxLAL IOL
Arm/Group Description	Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
Measure Participants	51
Measure Eyes	101
Count of Units [Eyes]	1

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	RxSight RxLAL IOL
Arm/Group Description	Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months
All Cause Mortality
	RxSight RxLAL IOL
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Serious Adverse Events
	RxSight RxLAL IOL
	Affected / at Risk (%)	# Events
Total	2/101 (2%)
Gastrointestinal disorders
Gastritis with diarrhea	1/51 (2%)	1
Surgical and medical procedures
IOL Explant	1/101 (1%)	1
Other (Not Including Serious) Adverse Events
	RxSight RxLAL IOL
	Affected / at Risk (%)	# Events
Total	28/101 (27.7%)
Eye disorders
Loss of BSCVA of ≥ 10 letters due to dry Eye	2/101 (2%)	2
Clinically significant cystoid macular edema	2/101 (2%)	2
Corneal Edema	1/101 (1%)	1
Blurred vision right eye	1/101 (1%)	1
Conjunctivitis	2/101 (2%)	2
Cornea Epithelialized with SPK	2/101 (2%)	2
Diabetic macular edema	3/101 (3%)	3
Increased protein distribution after lock-in procedure	1/101 (1%)	1
Giant cells on anterior surface of IOL	2/101 (2%)	2
Non-clinically significant cystoid macular edema	6/101 (5.9%)	6
Posterior Capsular Opacity	3/101 (3%)	3
Loss of BCDVA due to Posterior Capsular Opacity	2/101 (2%)	2
Loss of BCDVA due to lens aberrations	1/101 (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.