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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03729024
Other study ID # CSP-028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2018
Est. completion date February 4, 2020

Study information

Verified date August 2021
Source RxSight, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date February 4, 2020
Est. primary completion date April 15, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Mexico CODET Vision Institute Tijuana

Sponsors (1)

Lead Sponsor Collaborator
RxSight, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Eyes With UCDVA of 20/20 or Better 6 months
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