Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes

Sponsor
RxSight, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03895034
Collaborator
(none)
103
Enrollment
1
Location
1
Arm
20.6
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Center Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Actual Study Start Date :
Jun 14, 2018
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 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)
Eligible eyes will receive Light adjustable lens with Light delivery Device treatments

Outcome Measures

Primary Outcome Measures

  1. Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better [3 months post op]

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 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 pseudoexfoliation.

  • 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:
NCT03895034
Other Study ID Numbers:
  • CSP-032
First Posted:
Mar 29, 2019
Last Update Posted:
Sep 22, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Period Title: Overall Study
STARTED66
COMPLETED64
NOT COMPLETED2

Baseline Characteristics

Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group DescriptionLight Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Overall Participants66
Overall Eyes111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
67.4
(7.2)
Sex: Female, Male (Count of Participants)
Female
42
63.6%
Male
24
36.4%
Race/Ethnicity, Customized (Count of Participants)
Hispanic
66
100%
White
0
0%
Black
0
0%
Other
0
0%
Region of Enrollment (participants) [Number]
Mexico
66
100%
Eyes (Eyes) [Count of Units]
OD
56
OS
55

Outcome Measures

1. Primary Outcome
TitlePercent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Description
Time Frame3 months post op

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): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Measure Participants66
Measure Eyes109
Count of Units [Eyes]
101

Adverse Events

Time FrameThrough study completion, an average of 3 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): Eligible 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
Total0/66 (0%)
Serious Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Affected / at Risk (%)# Events
Total0/111 (0%)
Other (Not Including Serious) Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Affected / at Risk (%)# Events
Total25/111 (22.5%)
Eye disorders
Anterior Capsule Rupture1/111 (0.9%) 1
BCDVA Drop of 10 letters of more1/111 (0.9%) 2
Corneal Erosion1/111 (0.9%) 1
Corneal Guttata2/111 (1.8%) 2
Cystoid Macular Edema1/111 (0.9%) 1
Iris Atrophy1/111 (0.9%) 1
Iritis3/111 (2.7%) 4
Posterior Capsular Opacity2/111 (1.8%) 2
Superficial Punctate Keratitis11/111 (9.9%) 11
Vision changes including night vision changes2/111 (1.8%) 2

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:
NCT03895034
Other Study ID Numbers:
  • CSP-032
First Posted:
Mar 29, 2019
Last Update Posted:
Sep 22, 2021
Last Verified:
Aug 1, 2021