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

Sponsor
RxSight, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03729024
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
24.3
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 26, 2018
Actual Primary Completion Date :
Apr 15, 2019
Actual Study Completion Date :
Feb 4, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Outcome Measures

Primary Outcome Measures

  1. Percent of Eyes With UCDVA of 20/20 or Better [6 months]

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 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CODET Vision InstituteTijuanaMexico

Sponsors and Collaborators

  • RxSight, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
RxSight, Inc.
ClinicalTrials.gov Identifier:
NCT03729024
Other Study ID Numbers:
  • CSP-028
First Posted:
Nov 2, 2018
Last Update Posted:
Aug 6, 2021
Last Verified:
Aug 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.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group DescriptionLight Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
Period Title: Overall Study
STARTED21
COMPLETED21
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group DescriptionLight Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
Overall Participants21
Overall Eyes42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
68.3
(5.3)
Sex: Female, Male (Count of Participants)
Female
12
57.1%
Male
9
42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
18
85.7%
Not Hispanic or Latino
3
14.3%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
Mexico
21
100%

Outcome Measures

1. Primary Outcome
TitlePercent of Eyes With UCDVA of 20/20 or Better
Description
Time Frame6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group DescriptionLight Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
Measure Participants21
Measure Eyes42
Count of Units [Eyes]
41

Adverse Events

Time FrameThrough study completion, an average of 6 months
Adverse Event Reporting Description The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group DescriptionLight Adjustable lens (LAL) and Light Delivery Device (LDD): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
All Cause Mortality
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Affected / at Risk (%)# Events
Total0/21 (0%)
Serious Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Affected / at Risk (%)# Events
Total0/42 (0%)
Other (Not Including Serious) Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Affected / at Risk (%)# Events
Total1/42 (2.4%)
Eye disorders
Cystoid Macular Edema1/42 (2.4%) 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.

Results Point of Contact

Name/TitleJeffrey Ha, Senior Director of Clinical Research
OrganizationRxSight
Phone949-521-7870
Emailjha@rxsight.com
Responsible Party:
RxSight, Inc.
ClinicalTrials.gov Identifier:
NCT03729024
Other Study ID Numbers:
  • CSP-028
First Posted:
Nov 2, 2018
Last Update Posted:
Aug 6, 2021
Last Verified:
Aug 1, 2021