Light Adjustable Lens for Astigmatism

Not yet recruiting at 1 trial location
HP
Overseen ByHelga P Sandoval
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to correct astigmatism, a common vision problem causing blurriness, in individuals undergoing cataract or lens replacement surgery. It combines two treatments: precise laser cuts in the cornea, known as arcuate incisions, and a special lens called the Light Adjustable Lens (LAL), which can be adjusted after surgery to enhance vision. The trial evaluates the effectiveness of these treatments together, focusing on vision clarity and patient satisfaction. Individuals planning lens replacement surgery and having certain types of astigmatism may be suitable candidates. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known sensitivity to the medications planned for the study, you may not be eligible to participate.

What is the safety track record for the Light Adjustable Lens and arcuate incisions?

Research has shown that the Light Adjustable Lens (LAL) is generally well-tolerated. In one study with 600 participants, those who received the LAL were twice as likely to achieve excellent vision results compared to standard treatments. Specifically, 92% of participants attained their desired vision correction with high accuracy, suggesting that the LAL is both safe and effective.

For femtosecond laser arcuate incisions, research indicates they are as safe as traditional manual methods. In a study with 23 participants, only a small amount of remaining astigmatism was observed after surgery, demonstrating effective correction with no significant side effects.

Overall, both treatments in this trial have proven safe and successful in previous studies, with minimal adverse effects.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Light Adjustable Lens (LAL) for astigmatism because it offers a customizable approach to vision correction. Unlike traditional treatments like fixed lenses or glasses, the LAL can be precisely adjusted after implantation to fine-tune vision correction, allowing for personalized adjustments based on individual healing and visual needs. This adaptability is achieved through specialized light treatments that reshape the lens, offering a level of precision and personalization not available with standard options. With this innovative approach, patients have the potential for improved vision outcomes tailored specifically to their eyes.

What evidence suggests that this trial's treatments could be effective for astigmatism?

Research has shown that the Light Adjustable Lens (LAL), one of the treatments in this trial, effectively improves vision. Studies have found that it accurately corrects vision problems, helping people see clearly at various distances. This lens can be adjusted after surgery to fine-tune vision, enhancing its effectiveness.

Arcuate incisions, another treatment option in this trial, involve small cuts made in the eye to help reshape it. Studies show they effectively reduce astigmatism, a condition that causes blurred vision because the cornea is not perfectly round. These incisions remain stable and provide lasting improvements. Together, both treatments in this trial aim to enhance vision by addressing different aspects of the eye's shape and focus.16789

Who Is on the Research Team?

PM

Priya Mathews, MD

Principal Investigator

Center For Sight - Clinical Studies

Are You a Good Fit for This Trial?

This trial is for individuals with astigmatism or mixed astigmatism who are undergoing cataract or lens exchange surgery. Participants should be interested in correcting their vision using a combination of laser technology and an adjustable lens implant.

Inclusion Criteria

Subject must have a vector difference of 0.50 D or less in magnitude of pre-operative anterior corneal astigmatism as measured by the Pentacam AXL and the Zeiss IOLMaster 700 (Carl Zeiss Meditec)
Subject must be able and willing to comply with the study examination procedures
Astigmatic treatment must require paired arcs <45mm in length
See 5 more

Exclusion Criteria

Subject with known sensitivity to planned perioperative standard of care medications
I have a nerve-related eye condition.
Subject with known lens/zonular instability
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo femtosecond laser arcuate corneal relaxing incisions combined with Light Adjustable Lens implantation

1 day
1 visit (in-person)

Postoperative Assessment

Postoperative assessments focus on residual refractive astigmatism, visual outcomes, patient satisfaction, and incidence of adverse events

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Arcuate Incisions
  • Light Adjustable Lens (LAL)
Trial Overview The study tests the combined use of femtosecond laser arcuate corneal incisions (AK) and Light Adjustable Lens (LAL) implants to correct astigmatism during eye surgery. It compares this method's safety and effectiveness against established techniques.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Femto arcs + LALExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Center For Sight

Lead Sponsor

Trials
2
Recruited
90+

LensAR Incorporated

Industry Sponsor

Trials
3
Recruited
260+

Citations

Clinical Outcomes After Femtosecond Laser-Assisted ...Laser arcuate incisions appear to be an effective means of reducing postoperative refractive astigmatism at the time of cataract surgery.
One-Year Results of Arcuate Keratotomy in Patients With ...Paired surface-penetrating keratotomies created by a low-energy femtosecond laser showed efficient and stable CA reduction within 1 year after surgery.
Femtosecond Laser Arcuate Keratotomy vs Toric ...As the AK incisions were not separated, the effectiveness of astigmatism correction may have been reduced. Although several factors have ...
Five Years Follow-Up Outcomes of Femtosecond Laser- ...The femtosecond laser-assisted cataract surgery is safe and long effective in correcting the corneal astigmatism in patients with preexisting corneal ...
Predictability of Astigmatism Correction by Arcuate ...The follow-up time was up to 6 weeks. Retrospective data showed a significant reduction in postoperative astigmatism. A total of 79.4% showed a postoperative ...
Safety and Effectiveness of Arcuate Incisions Performed ...Demonstration of agreement: Corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by ...
Comparison of Toric Intraocular Lenses and Arcuate ...Using the Lindstrom nomogram,12 paired arcuate relaxing incisions reduced astigmatism by a mean of 43% from baseline, whereas implantation of a toric IOL ...
Efficacy & safety of the laserarcs.com nomogram | OPTHOne study of 23 patients by Yoo13 with 1.0 to 3.0 D of preoperative astigmatism reported postoperative cylinder of 0.79 ± 0.11 D at one month.
Outcomes of Femtosecond Laser-Assisted Arcuate ...The surgically induced astigmatism (SIA) magnitude was higher in LKP (8.65 ± 5.74 D) than in PKP (7.15 ± 4.59 D) (p = 0.456). Mean error (ME) was closer to zero ...
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