Clinical trial NCT03771352: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract surgery
eye disease
lenticular opacification
Lead sponsor: RxSight, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
timeFrame: at 6 months postop
Secondary outcomes:
Other outcomes:
measure: Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)
timeFrame: Through study completion, an average of 6 months
measure: Number of Eyes That Received Secondary Surgical Interventions (SSIs)
timeFrame: Through study completion, an average of 6 months
Locations:
city: Bochum
country: Germany
facility: University Eye Clinic
city: Heidelberg
country: Germany
facility: University Eye Clinic
city: Ayr
country: United Kingdom
facility: Ayrshire Eye Clinic and Laser Center
state: Scotland
Study officials:
affiliation: University Eye Clinic- Bochum, Germany
name: Burkhard Dick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Eye Clinic- Heidelberg, Germany
name: Fritz Hengerer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ayrshire Eye Clinic and Laser Center
name: Sathish Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References: