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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postop month 6
Awards & highlights
Study Summary
This trial will compare the safety of a new type of intraocular lens to a control lens.
Who is the study for?
This trial is for English-speaking adults aged 40-80 who are willing to undergo cataract surgery and can follow the study's procedures. Participants will be randomly assigned to receive either the RxSight Light Adjustable Lens (LAL) or a standard monofocal lens. People with eye conditions like ectasia, dense cataracts that block macula examination, previous eye surgeries (except certain pterygium excisions), macular disease, uveitis, or ocular herpes simplex virus cannot join.Check my eligibility
What is being tested?
The study aims to compare the safety outcomes of two types of intraocular lenses: the RxSight Light Adjustable Lens (LAL), which can be adjusted after implantation using a special light delivery device, and a standard monofocal control lens implanted during cataract surgery.See study design
What are the potential side effects?
Potential side effects were not specified in the provided information. However, common risks associated with intraocular lenses include inflammation, infection risk post-surgery, visual disturbances such as glare and halos around lights, and potential need for additional procedures if adjustments are required.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postop month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postop month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Secondary outcome measures
Rate of endothelial cell density loss
Rate of retinal findings
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Light adjustable lens (LAL) and Light Delivery Device (LDD)Experimental Treatment1 Intervention
Group II: Control IOLActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
2018
N/A
~200
Find a Location
Who is running the clinical trial?
RxSight, Inc.Lead Sponsor
5 Previous Clinical Trials
272 Total Patients Enrolled
5 Trials studying Cataract
272 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had herpes in my eye before.I am between 40 and 80 years old.I have had eye surgery, but if it was for pterygium, it did not extend more than 2mm onto the cornea.I agree to cataract surgery and to be randomly assigned an implant.I am between 40 and 80 years old.My cataracts are dense enough to block a clear view of my macula.I am taking medication that could harm my eyesight, like tamoxifen.I have had uveitis in one or both of my eyes.I agree to cataract surgery and to be randomly assigned an IOL type.I have a pre-existing condition affecting the central part of my eye's retina.I am on medication that makes my skin more sensitive to sunlight.
Research Study Groups:
This trial has the following groups:- Group 1: Light adjustable lens (LAL) and Light Delivery Device (LDD)
- Group 2: Control IOL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any medical centers in this state that are conducting this research?
"Vold Vision in Fayetteville, Arkansas; The Eye Institute of West Florida in Largo, Florida; and Vance Thompson Vision Clinic in Sioux Falls, South dakota are among the 15 medical centres that are recruiting for this trial."
Answered by AI
Are there any qualifications which make someone a particularly suitable candidate for this research?
"Entry into this trial demands that individuals have been diagnosed with cataracts and are between 40 to 80 years old. Altogether, it is desired for 500 patients to join the study."
Answered by AI
Is this research study open to participants aged 55 or higher?
"Participants of this medical trial must fit into the 40 to 80 year old demographic. For younger and older age groups, there are respectively 11 and 120 trials available."
Answered by AI
Are there any open recruitment opportunities for this research experiment?
"Affirmative, the information available on clinicaltrials.gov alludes that this scientific experiment is currently sourcing participants. The study was initially made public on December 3rd 2021 and most recently revised July 6th 2022. This trial requires 500 patients to be recruited across 14 research centres."
Answered by AI
Who else is applying?
What site did they apply to?
The Eye Institute of West Florida
Vance Thompson Vision
Cleveland Eye Clinic
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am interested in lenses that will allow me to see well at all focal lengths.
PatientReceived 1 prior treatment
My vison is getting worst and i am needing to get this matter taken care asap.
PatientReceived 1 prior treatment
Interested in best options for cataracts surgery. Looking for surgery sooner rather than later.
PatientReceived no prior treatments
I have an cataract diagnosis. Also I have astigmatism and have had LASIK which may make obtaining the best IOL out of my reach, since Medicare sets the insurable limits.
PatientReceived no prior treatments
As a Registered Nurse I am familiar with clinical trials and the importance they plan in the healthcare arena. I have researched LAL and know this is the best option for my cataract treatment.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
1. How many visits are estimated for the trial? How long is the duration of the trial for a patient? What costs are involved for a patient?
PatientReceived 1 prior treatment
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