Exploring Clinical Trials for Laser Eye Surgery in the USA

Laser eye trials help test new ways to fix sight. These tests use safe tools to help eyes see well. They cut time, pain, and cost for those who join. You may try new care first, with pro staff to check your eyes. Ask if these trials can help you.

Exploring Clinical Trials for Laser Eye Surgery in the USA

Laser eye surgery has become a popular method for correcting various vision issues, such as nearsightedness, farsightedness, and astigmatism. These procedures, which include LASIK and PRK (Photorefractive Keratectomy), offer life-changing results by providing clearer vision without the need for glasses or contact lenses. However, advancements in laser eye surgery are constantly evolving, and clinical trials play a crucial role in improving the effectiveness, safety, and accessibility of these surgeries.

Clinical trials for laser eye surgery provide an excellent opportunity for individuals to access cutting-edge procedures and treatments before they become widely available. By participating in a clinical trial, patients can benefit from innovative techniques and technologies while contributing to medical research that could help others in the future.

In this article, we’ll explore the significance of clinical trials for laser eye surgery, the types of research being conducted, and how patients in the USA can find and participate in these trials.

The Importance of Clinical Trials for Laser Eye Surgery

Clinical trials are essential for the development of new treatments and the refinement of existing procedures. In the field of laser eye surgery, these trials can lead to significant improvements in safety, effectiveness, and patient outcomes. For example, new laser technologies may be tested to enhance precision and reduce complications during surgery, while novel post-operative care methods could speed up recovery times.

Participating in a clinical trial offers several benefits, including:

  1. Access to the Latest Technology: Patients enrolled in clinical trials may be among the first to receive new, cutting-edge treatments that are not yet available to the public.
  2. Cost Savings: Many clinical trials cover the costs of the procedure, allowing participants to receive high-quality care at a reduced price or even for free.
  3. Improved Care: Participants are closely monitored throughout the trial by medical professionals, ensuring that they receive excellent care and attention.
  4. Contributing to Research: By joining a clinical trial, participants help researchers collect data that can lead to the development of safer and more effective treatments for future patients.

Types of Clinical Trials for Laser Eye Surgery

Various types of clinical trials are being conducted to improve different aspects of laser eye surgery. These trials may focus on testing new laser technologies, refining surgical techniques, or evaluating new methods for post-surgery care. Here are some of the key areas of research being explored:

1. New Laser Technologies

Laser eye surgery relies on the use of precise lasers to reshape the cornea and correct vision. Clinical trials are often conducted to test new lasers that could offer better precision, faster results, and fewer side effects. Some of these lasers may target specific corneal layers more accurately, reducing the risk of complications such as halos or glare after surgery.

2. Customized Vision Correction

Clinical trials are also focused on personalized or customized vision correction. Standard LASIK or PRK procedures may not fully address certain vision imperfections, such as higher-order aberrations (small optical imperfections in the eye). In response, researchers are exploring ways to customize surgeries to correct these imperfections, providing patients with even clearer and sharper vision.

3. Improved Recovery Protocols

Recovery from laser eye surgery typically involves a few days of discomfort and blurry vision, followed by a gradual improvement in eyesight. Researchers are conducting clinical trials to test new medications, eye drops, and therapies that could speed up recovery times and reduce post-surgery discomfort. These studies aim to make recovery smoother for patients, allowing them to return to normal activities more quickly.

4. Expanded Patient Eligibility

Historically, certain individuals have not been suitable candidates for laser eye surgery due to thin corneas, severe refractive errors, or other pre-existing eye conditions. Clinical trials are being conducted to explore new techniques and procedures that could expand eligibility for laser eye surgery, making it accessible to a broader range of patients.

5. Long-Term Outcomes and Safety

Laser eye surgery has been proven to be safe and effective for most patients. However, researchers are constantly working to improve long-term outcomes and ensure that complications are minimized. Clinical trials are designed to study the long-term effects of laser eye surgery, helping medical professionals to refine the procedure and enhance safety for all patients.

Here Is The List Of Clinical Trials For Laser Eye Surgery

Standford Medicine

  • StanFord Medicine allows you to search for clinical trials for Laser Eye Surgery

Elita Laser Vision Correction

Small incision lenticule keratomileusis is a one-step procedure consisting of initial creation of a corneal flap (a thin slice of the cornea) and subsequent corneal ablation (removal of tissue) with an excimer laser (a non-thermal laser). The cornea is the clear front portion of the eye.  The femtosecond laser is used to create the corneal flap during the first step of the LASIK procedure. The excimer laser system precisely ablates (removes) corneal tissue to reduce or eliminate your nearsightedness, farsightedness, astigmatism and mixed astigmatism.  

The Elita femtosecond laser used to perform SILK surgery is not FDA-approved.  It is an investigational device.  It has been used in humans outside the United States.  SILK surgery has been performed in 154 patients outside of the United States.

You will have one eye or both eyes treated with small incision lenticule keratomileusis using the Elita femtosecond laser system.

You will be one of up to 90 near-sighted patients at Stanford to undergo treatment in this clinical research trial.  Two hundred patients will be enrolled study wide at up to 15 study sites in the United States and part of the multicenter clinical trial.

A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Quality of Vision and Quality of Life With LASIK

The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.

A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Eligibility Criteria for Laser Eye Surgery Clinical Trials

Each clinical trial will have specific eligibility criteria that must be met before you can participate. These criteria may include factors such as age, eye health, refractive error, and overall health status. Some trials may only accept patients with certain conditions, while others may be open to a broader range of participants.

Before enrolling in a clinical trial, you will undergo a thorough screening process to determine whether you qualify. If accepted, you’ll receive detailed information about the procedure, potential risks, and the follow-up care required.

Conclusion

Clinical trials for laser eye surgery are a valuable opportunity for patients to access new treatments and contribute to the advancement of medical research. Whether you’re interested in trying the latest laser technologies, benefiting from improved recovery protocols, or helping expand patient eligibility for surgery, participating in a clinical trial could be a beneficial option.

By taking part in a clinical trial, you can play a role in shaping the future of laser eye surgery while receiving top-tier care. If you're considering laser eye surgery and want to explore clinical trial opportunities, consult with your surgeon or research local trials to find the best option for you.