Back to resultsClinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RxSight RxLAL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring cataract surgery, eye disease, lenticular opacification
Eligibility Criteria
Inclusion Criteria:
- Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL.
- Greater than the age of 40 on the day the cataract surgery is performed.
- Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
- Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
- Willing and able to comply with the requirements for study specific procedures and visits.
Exclusion Criteria:
- Zonular laxity or dehiscence.
- Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
- History of uveitis
- Keratoconus or suspected of having keratoconus.
- Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
- Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
- Subjects taking systemic medications 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
- History of congenital color vision defect
Sites / Locations
- University Eye Clinic
- University Eye Clinic
- Ayrshire Eye Clinic and Laser Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
RxSight RxLAL IOL
Arm Description
Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)
Outcomes
Primary Outcome Measures
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771352
Brief Title
Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism
Official Title
A Prospective Multi-Center Clinical 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
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract surgery, eye disease, lenticular opacification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RxSight RxLAL IOL
Arm Type
Other
Arm Description
Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)
Intervention Type
Device
Intervention Name(s)
RxSight RxLAL
Other Intervention Name(s)
Light Adjustable Lens, Light Delivery Device
Intervention Description
The patients will be assessed for 6 months
Primary Outcome Measure Information:
Title
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Description
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
Time Frame
at 6 months postop
Other Pre-specified Outcome Measures:
Title
Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)
Description
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
Time Frame
Through study completion, an average of 6 months
Title
Number of Eyes That Received Secondary Surgical Interventions (SSIs)
Description
Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL.
Greater than the age of 40 on the day the cataract surgery is performed.
Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
Willing and able to comply with the requirements for study specific procedures and visits.
Exclusion Criteria:
Zonular laxity or dehiscence.
Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
History of uveitis
Keratoconus or suspected of having keratoconus.
Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
Subjects taking systemic medications 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
History of congenital color vision defect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burkhard Dick, MD
Organizational Affiliation
University Eye Clinic- Bochum, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fritz Hengerer, MD
Organizational Affiliation
University Eye Clinic- Heidelberg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sathish Srinivasan, MD
Organizational Affiliation
Ayrshire Eye Clinic and Laser Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Clinic
City
Bochum
Country
Germany
Facility Name
University Eye Clinic
City
Heidelberg
Country
Germany
Facility Name
Ayrshire Eye Clinic and Laser Center
City
Ayr
State/Province
Scotland
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism
We'll reach out to this number within 24 hrs