LASIK for Astigmatism

Phase-Based Estimates
1
Effectiveness
1
Safety
Contact Alcon Call Center for Trial Locations, Fort Worth, TX
Astigmatism+2 More
LASIK - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Astigmatism

Study Summary

This study is evaluating whether a laser may be used to correct vision.

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Eligible Conditions

  • Astigmatism
  • Hyperopia
  • Hyperopic Astigmatism

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether LASIK will improve 3 primary outcomes in patients with Astigmatism. Measurement will happen over the course of Preoperative, up to Month 12.

Month 12
Percentage of eyes with MRSE within ±1.00 D at refractive stability
Percentage of eyes with manifest refraction spherical equivalent (MRSE) within ±0.50 diopter (D) at refractive stability
Up to Month 12
Percentage of eyes experiencing ocular adverse events (AEs)

Trial Safety

Trial Design

2 Treatment Groups

Control
WaveLight EX500 excimer laser system

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. LASIK 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.

WaveLight EX500 excimer laser systemLaser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LASIK
2016
Completed Phase 4
~720

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to month 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to month 12 for reporting.

Closest Location

Contact Alcon Call Center for Trial Locations - Fort Worth, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient's vision is stable as specified in the protocol. show original
Can be used unilaterally Intended to be used bilaterally, the device can also be used unilaterally. show original
Hyperopia is present in some people who have or do not have astigmatism, as specified in the research study protocol. show original
You may be eligible for the study if you meet other criteria that the protocol defines. show original
Key

Patient Q&A Section

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

Does astigmatism run in families?

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There was no evidence that astigmatism runs in families. Astigmatism in the parents or siblings does not influence astigmatism in the other family members. Astigmatism in the offspring may be related to the environmental factors or to genetic and/or epigenetic factors.

Unverified Answer

What causes astigmatism?

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While the amount of astigmatism depends on a variety of factors, this data highlights the impact of the corneal stromal collagen fibers on the refraction axis in the absence of a systemic disorder. Results from a recent clinical trial demonstrate a strong role for the corneal stroma of the cornea on the axis of refraction of the eye.

Unverified Answer

Can astigmatism be cured?

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[A 2005 study(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC23152655/) found that a surgical correction of astigmatism had a 2.5-fold improvement in the patients' subjective visual quality of life and a 50% reduction in the need for eyeglasses. To find active astigmatism clinical trials, use Power(http://www.withpower.com/clinical-trials/astigmatism) to search recent trials by condition, treatment, or location. Astigmatism surgery is not always used as a first-line treatment, but it is used first line or second line for patients with cornea-damaged eyes.

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

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A recent publication showed that 20% of U.S. adults report experiencing astigmatism during the previous 3 months. In addition, a recent study estimates that 18% of Americans have accommodative astigmatism, or myopic astigmatism. An additional 2% of eyes may be hyperopic, or farsighted, which can lead to amblyopia. However, the most frequent complaint related to astigmatism is double vision, which has been called "the biggest mis-diagnosis of any eye disease in the USA.

Unverified Answer

What is astigmatism?

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Astigmatism is a common condition that causes a deterioration in vision. It is sometimes called'sightedness,' though it is not the same as myopia. Many factors can lead to astigmatism, such as genetics, intrauterine growth retardation, early vision problems or visual deprivation during childhood. Astigmatism is also a common cause of a number of diseases in children.\n

Unverified Answer

What are common treatments for astigmatism?

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For astigmatism that does not meet the criteria for refractive correction, a multifractal toric intraocular lens with posterior pole flap will correct better the corneal astigmatism to ensure the refraction of the eyes is near natural.

Unverified Answer

What are the signs of astigmatism?

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Astigmatism is most commonly seen when using a microscope. Its symptoms can be attributed to poor visual acuity due to poor myopia control or to hypermetropia. Astigmatism can be treated with appropriate intraocular lenses.

Unverified Answer

How serious can astigmatism be?

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Astigmatism can be an important factor in the appearance of eye dryness, as well as in the correction of refractive errors, thus it is crucial to determine it early. Eye drop and/or prismatic correction and/or laser surgery must be considered as first-line modalities in severe irregular astigmatism.

Unverified Answer

What are the common side effects of lasik?

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This is the first study to report on the common side effects of LASIK and it showed that most of the side effects were transient. Postoperative patients should be evaluated by a specialist eye care provider before surgery.

Unverified Answer

How does lasik work?

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[For the first time, we report that the visual outcome of myopic patients (corrected by LASIK) with the Nidek EZ 200 laser is good, similar to that found in nonmyopic patients, with a success rate about 93%. There was no difference between the groups in the visual outcome after 1 week or 1 year (p >.05). A slight increase of 0.02 diopters at the end of the evaluation compared to baseline is noticed in patients of the LASIK group of the EZ 200 laser because of the refractive error reduction with refractive surgery. LASIK eye surgery can be performed on most patients with myopia with similar success rates as those of nonmyopic patients.

Unverified Answer

Has lasik proven to be more effective than a placebo?

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In a retrospective study of the patients recruited from the American Osteopathic Association's National Eye Institute database, there was no difference in visual correction between the use of LASIK and a control group of non-treated patients.

Unverified Answer

What is the primary cause of astigmatism?

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Most astigmatism is likely to be caused by factors that are not related to refractive error, while some of it is probably related to lifestyle and demographic factors.

Unverified Answer
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