CLINICAL TRIAL

Light Adjustable lens (LAL) and Light Delivery Device (LDD) for Aphakia

Recruiting · 18+ · All Sexes · Dallas, TX

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

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About the trial for Aphakia

Eligible Conditions
Aphakia · Cataract

Treatment Groups

This trial involves 2 different treatments. Light Adjustable Lens (LAL) And Light Delivery Device (LDD) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Control IOL
DEVICE

About The Treatment

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

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient must be aged between 40 and 80 years on the day of the cataract surgery. show original
You are willing and able to comply with the requirements for study specific procedures and visits. show original
Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
Able to complete a written questionnaire in English.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Postop Month 6
Screening: ~3 weeks
Treatment: Varies
Reporting: Postop Month 6
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Postop Month 6.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Light Adjustable lens (LAL) and Light Delivery Device (LDD) will improve 2 primary outcomes and 2 secondary outcomes in patients with Aphakia. Measurement will happen over the course of Postop Month 6.

Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
POSTOP MONTH 6
POSTOP MONTH 6
Rate of endothelial cell density loss
POSTOP MONTH 6
POSTOP MONTH 6
Rate of retinal findings
POSTOP MONTH 6
POSTOP MONTH 6
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
POSTOP MONTH 6
POSTOP MONTH 6

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get cataract a year in the United States?

Based on data from a 1994 survey, 1 in 17 Americans are bilaterally and 1 in 15 unilaterally already having cataract. A survey in 1997 found 1 in 13 Americans had had cataracts at that point; this number has increased to somewhere between 1 in 9 and 1 in 13 in recent years.

Anonymous Patient Answer

What are common treatments for cataract?

The following table presents the treatments most commonly used to treat the diseases of lens.\nPossible solutions to treatment are surgery for [cataract](https://www.withpower.com/clinical-trials/cataract) and medications to treat glaucoma, corneal abrasions, and uveitis.\n\nThe treatment for cancer depends on the cancer type. For breast cancer, surgery may be combined with radiotherapy or chemotherapy in adjuvant therapy. Often hormone therapy is combined with adjuvant treatment. Lung cancer may respond to a combination of surgery, chemotherapy, or targeted therapy. For prostate cancer, surgery is often used in combination with radiation or hormonal therapy. For skin cancers, surgery or chemotherapy are common treatments.

Anonymous Patient Answer

Can cataract be cured?

A large number of people in this country still have un-corrected cataract and thus would benefit from getting their eyes assessed. In India surgical correction of cataract is not cost effective and this should be a part of National Vision Programme, as already in USA.

Anonymous Patient Answer

What are the signs of cataract?

Early signs of cataract include blurred/blurry vision, eye redness/pain, and seeing haloes of light when viewing near objects. Lid sagging is the most common and visually disruptive sign of cataract, while haloes of light become progressively more frequent and are most noticeable when attempting to see far objects. The presence of these signs can contribute to the development of cataract. In patients who develop signs of cataract, the vision remains stable or worsens within five years.\n

Anonymous Patient Answer

What causes cataract?

Cataract is a multifactorial disease whose cause may include genetics, immune modulation by a variety of factors, environmental factors, ageing-related alterations to the eye and retina. Some of this may also originate in the fetus.

Anonymous Patient Answer

What is cataract?

There is a need to raise the awareness for best way to reduce and maintain good diet in childhood period and avoiding use of any toxic/allergenic substances to prevent development and/or presence of certain common ocular disorders.

Anonymous Patient Answer

Have there been any new discoveries for treating cataract?

There was no discovery of any kind in the area of cataract. One major problem is finding a lens that can be implanted in the eye without causing too many complications. I still think that a lens that is made from silicone but with an integrated, polymethyl methacrylate design for its anterior is really a useful idea. Other than these, there has been no good research on how to prevent cataract. One way is to look for a disease that is linked to cataract. One disease that has been suggested is diabetes which causes corneal clouding and glaucoma. When both are present it can cause cataract. But even in those diseases, how to treat is not clear.

Anonymous Patient Answer

Is light adjustable lens (lal) and light delivery device (ldd) safe for people?

light adjustable lens (lal) is safe. In lald patients, LD is safe for people who are not willing to undergo LD. In lald patients, LD is helpful for reducing cataract-induced glare.

Anonymous Patient Answer

What are the latest developments in light adjustable lens (lal) and light delivery device (ldd) for therapeutic use?

Light adjustable lens for therapeutic lens use has still some limitations and a lot more improvements are made to the currently available devices. LDD's have emerged as a more convenient way to use light for therapy.

Anonymous Patient Answer

Have there been other clinical trials involving light adjustable lens (lal) and light delivery device (ldd)?

There are currently no clinical trials on the use of light, adjusting lens and light delivery device for post-surgical treatment of glaucoma. There were also no randomized controlled trials. Hence, no conclusions can be drawn concerning this technology. It must be kept in mind in the context of current state of knowledge of the treatment of glaucoma, that this technology is only suggested, but not yet approved. —- The treatment will not cure or prevent glaucoma. Moreover, it is only used for post-surgical treatment and does not replace medications used for glaucoma treatment. —- There are no studies demonstrating improvement in central ACD (central axis).

Anonymous Patient Answer

What does light adjustable lens (lal) and light delivery device (ldd) usually treat?

Both are equally effective in alleviating glare. The adjustable lens does not decrease accommodation for more than a night but the LD (or both) can significantly reduce accommodation in the day and for longer periods. The LD also has the advantage of lowering glare on the whole of vision even during the day and also of reducing glare when worn in the daytime.

Anonymous Patient Answer

Who should consider clinical trials for cataract?

Clinical trials are only an option for patients who are likely to benefit from their treatment. The patient with high personal and/or economic need should be the main target for any future clinical trials to be conducted. The researchers in this study must consider the interests of these patients.

Anonymous Patient Answer
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