NCT04005586

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

June 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 11, 2021

Completed
Last Updated

June 11, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

June 26, 2019

Results QC Date

March 18, 2021

Last Update Submit

May 14, 2021

Conditions

AphakiaCataract

Keywords

Light Delivery DeviceLDDIntraocular lensLight Adjustable LensLAL

Outcome Measures

Primary Outcomes (2)

  • Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups

    Post Op Month 3

  • Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups

    Post Op Month 3

Other Outcomes (1)

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

    Through study completion, an average of 3 months

Study Arms (1)

Light Delivery Device (LDD)

EXPERIMENTAL

Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.

Device: Light Delivery Device (LDD)

Interventions

Light Delivery Device (LDD)DEVICE

Study eye will undergo Light delivery Device treatments

Light Delivery Device (LDD)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
  • A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
  • Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
  • Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
  • Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
  • Willing and able to comply with the requirements for study specific procedures and visits

You may not qualify if:

  • Pre-existing macular disease in the study eye.
  • History of uveitis in the study eye.
  • Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and 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 the study eye.
  • Subject who has participated within another ophthalmic clinical trial within the last 3 months.
  • Sutures used at the time of surgery to close the incision wound in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

AphakiaCataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

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

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
Model Details: All subjects will receive the same treatment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 2, 2019

Study Start

July 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 11, 2021

Results First Posted

June 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)