NCT03771352

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
Last Updated

June 9, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

November 30, 2018

Results QC Date

March 19, 2021

Last Update Submit

May 24, 2021

Conditions

Cataract

Keywords

cataract surgeryeye diseaselenticular opacification

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better

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

    at 6 months postop

Other Outcomes (2)

  • Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)

    Through study completion, an average of 6 months

  • Number of Eyes That Received Secondary Surgical Interventions (SSIs)

    Through study completion, an average of 6 months

Study Arms (1)

RxSight RxLAL IOL

OTHER

Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)

Device: RxSight RxLAL

Interventions

RxSight RxLALDEVICE

The patients will be assessed for 6 months

Also known as: Light Adjustable Lens, Light Delivery Device
RxSight RxLAL IOL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Eye Clinic

Bochum, Germany

Location

University Eye Clinic

Heidelberg, Germany

Location

Ayrshire Eye Clinic and Laser Center

Ayr, Scotland, United Kingdom

Location

MeSH Terms

Conditions

CataractEye Diseases

Condition Hierarchy (Ancestors)

Lens Diseases

Results Point of Contact

Title
Jeffrey Ha, Senior Director of Clinical Research
Organization
RxSight
jha@rxsight.com
949-521-7870

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 11, 2018

Study Start

June 19, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

June 9, 2021

Results First Posted

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)DE(2)