Treatment for Myopia

Phase-Based Estimates
1
Effectiveness
1
Safety
Stanford University School of Medicine, Stanford, CA
Myopia+2 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Myopia

Study Summary

This study is evaluating whether wavefront-guided excimer laser treatment is more effective than wavefront-optimized excimer laser treatment for correcting myopia, hyperopia and astigmatism.

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Eligible Conditions

  • Myopia
  • Hyperopia
  • Astigmatism

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes and 3 secondary outcomes in patients with Myopia. Measurement will happen over the course of One year.

One year
Changes in 25 and 5% low contrast visual acuity.
Changes in best spectacle corrected visual acuity.
Changes in higher order aberrations.
Improvement in uncorrected visual acuity
Quality of vision changes.
Topographic changes.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Wavefront guided LASIK/PRK

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment 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.

Wavefront guided LASIK/PRK
Procedure
Wavefront-guided LASIK/PRK
Wavefront optimized LASIK/PRK
Procedure
Wavefornt optimized LASIK/PRK

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year for reporting.

Closest Location

Stanford University School of Medicine - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Healthy subjects age 21 and older.
Subjects with nearsightedness, farsightedness and/or astigmatism.

Patient Q&A Section

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

What are common treatments for myopia?

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Glasses are commonly recommended for high myopia. Contact lenses are used in low myopia with high refractive error. For low myopia to high refractive error, glasses are more commonly used.

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What is myopia?

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Myopia is usually caused by not focusing light images through lenses after seeing other images. It is also called nearsightedness or focusing on close objects. The condition of having difficulty focusing can be cured with glasses or contact lenses and in some cases surgical removal of the eyes' muscles, or by the insertion of a small lens in front of the eye. When eyesight deteriorates, this causes myopia. Although myopia was common during an earlier era, it is now much infrequent. The more you have it, the more pronounced the problem is. Although many children have it, it is less common among the elderly, and it is often found in those who are in the process of gaining weight.

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What causes myopia?

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Myopia occurs at a rate in the general population about one out of 1000 persons, and an estimated 25 million people globally have myopic retinal images. The myopic refractive error occurs at an early age as seen in the young myopic children in the cohort study conducted in this township. At the same time the prevalence of myopia increases with age and it is higher than the prevalence of myopia in the population. The prevalence of myopia is higher in urban children, and myopia in children is more likely to be acquired in rural areas than in urban areas during early childhood. The urban children are more likely to have parents whose education is below 8th grade and the rural children are more likely to have parents who are in agriculture.

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What are the signs of myopia?

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Myopia may be evident by excessive staring at close-up objects, but is usually noticed first in preschool children for refractive reasons. Signs may include a lazy eye and distant objects will appear blurry.

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Can myopia be cured?

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There has been a wide range of proposals for the use of lenses to correct myopia. Although vision will improve, most people with myopia have a limited range of vision and may remain unsatisfied. Myopia that is a chronic disorder, usually becomes a limitation when people grow older.

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

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Between 16% to 43% of U.S. adults have myopia at least once a year, and 40% are hyperopic. Hyperopia can be associated with myopia in adulthood, although the correlation is weaker. The myopia/intellectual ability relationship varies with the definitions used in these studies.

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How serious can myopia be?

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It is difficult to guess which children with myopia would be at greatest risk for developing other eye conditions, as they are not more likely to have a sibling with myopia or to use eye protection in childhood. Children with myopia may also use contact lenses of shorter duration, or other less harmful means in childhood than those without myopia. For all patients having contact lenses, the risk of developing glaucoma is highest in the first three months of lens use, and the risk of developing high-risk retinal damage is highest at least 10 years after lens removal (about age 25).

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Does treatment improve quality of life for those with myopia?

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Patients with myopia reported significant gains in the quality of their lives after treatment with orthokeratology. Orthokeratology is a simple, inexpensive, effective strategy that can markedly improve the quality of life in a group of patients with myopia.

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What is the latest research for myopia?

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Evidence-based information regarding myopia is limited and often inadequate for treating myopia, causing uncertainty and concern regarding its diagnosis and treatment. Additionally, there are many questions regarding whether there are any risks of having the laser treatment to which refractive errors respond well. The most recent research suggests that many of the most important questions have been answered. Further, other treatments or methods of treatment that have been studied are under investigation and remain uncertain (Laser Vision Therapy vs. Contact lenses). The future of refractive science, especially for refractive surgery, needs to continue to focus on the effectiveness of these treatments, their safety, and their long-term effectiveness.

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Has treatment proven to be more effective than a placebo?

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No significant difference could be demonstrated between treatments and a placebos. It would seem that this study does not refute the concept of refractive surgery, but instead, its effect in the visual rehabilitation of astigmatic refractive errors.

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What is the primary cause of myopia?

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Results from a recent clinical trial showed that the primary cause of myopia was not the difference in the corneal diameters, but rather in the refraction, the distance between the eye and the lens. And the correlation between myopia and eye length was statistically significant. Moreover, there are some eye abnormalities that may be present before the occurrence of myopia. Results from a recent clinical trial suggest to the public that myopia is not caused by changes in eye structures or length, but rather, it is related to eye length. [Power (https://www.withpower.com/clinical-trials/eye-injuries-lamp-bulb-injury-syndrome) or [www.cnlmsinstitute.gov/pages/research.

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What is treatment?

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In myopia, it should first be established what is the best treatment and then the patient should receive that particular treatment. For example, a treatment course can be divided into two parts at first as follows:\n- First part of treatment: is that patient is ready to be treated for myopia? First of all, the myopia should be controlled in an asymptomatic way that is the easiest and the most cost effective way. An untreated patient who already has myopia, but does not need surgery, cannot receive an effective treatment for myopia in the future because of the risk of developing high myopia if treatment is withheld.

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