Back to results

Exploratory 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

Primary Purpose

Aphakia, Cataract

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Light Adjustable lens (LAL) and Light Delivery Device (LDD)

About this trial

This is an interventional treatment trial for Aphakia focused on measuring Light Adjustable Lens, Intraocular lens, LAL

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

Study eye with zonular laxity or dehiscence.
Study eye with pseudoexfoliation.
Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
Study eye with diabetes with any evidence of retinopathy.
Study eye with evidence of glaucomatous optic neuropathy.
Study eye with history of uveitis.
Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.
Study eye with history of ocular herpes simplex virus.
Study eye with history of a congenital color vision defect

Sites / Locations

CODET Vision Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Light adjustable lens (LAL) and Light Delivery Device (LDD)

Arm Description

Outcomes

Primary Outcome Measures

Percent of Eyes With UCDVA of 20/20 or Better

Secondary Outcome Measures

Full Information

NCT ID

NCT03729024

First Posted

October 31, 2018

Last Updated

August 4, 2021

Sponsor

RxSight, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03729024

Brief Title

Exploratory 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

Official Title

A Single Center Exploratory 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

January 26, 2018 (Actual)

Primary Completion Date

April 15, 2019 (Actual)

Study Completion Date

February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RxSight, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphakia, Cataract

Keywords

Light Adjustable Lens, Intraocular lens, LAL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Light adjustable lens (LAL) and Light Delivery Device (LDD)

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Intervention Description

Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Primary Outcome Measure Information:

Title

Percent of Eyes With UCDVA of 20/20 or Better

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL. Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D. Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source. Willing and able to comply with the requirements for study specific procedures and visits. Exclusion Criteria: Study eye with zonular laxity or dehiscence. Study eye with pseudoexfoliation. Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen. Study eye with diabetes with any evidence of retinopathy. Study eye with evidence of glaucomatous optic neuropathy. Study eye with history of uveitis. Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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. Study eye with history of ocular herpes simplex virus. Study eye with history of a congenital color vision defect

Facility Information:

Facility Name

CODET Vision Institute

City

Tijuana

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

We'll reach out to this number within 24 hrs