Status:
COMPLETED
Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism
Lead Sponsor:
RxSight, Inc.
Conditions:
Cataract
Eligibility:
All Genders
40+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03771352
Start Date
June 19 2018
End Date
July 1 2020
Last Update
June 9 2021
Active Locations (3)
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1
University Eye Clinic
Bochum, Germany
2
University Eye Clinic
Heidelberg, Germany
3
Ayrshire Eye Clinic and Laser Center
Ayr, Scotland, United Kingdom