Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism.
2020年8月24日 更新者:Bausch & Lomb Incorporated
A Prospective Trial to Evaluate the Safety and Effectiveness of the Bausch & Lomb Technolas® 217z Laser With Zyoptix® Aspheric Algorithm When Used for the LASIK Treatment of Myopia and Myopic Astigmatism
The purpose of this study is to evaluate the safety and effectiveness of the Bausch & Lomb Technolas 217z laser with the investigational Zyoptix Aspheric Algorithm when used for LASIK treatment of myopia and myopic astigmatism.
調査の概要
研究の種類
介入
入学 (実際)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5X1C8
- Lasik MD, 130 King Street
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects who were of legal age (at least 18) and had full legal capacity to volunteer.
- Subjects must be willing to have both eyes treated with the laser.
- Subjects must have up to -12.00D of absolute spherical myopia (not spherical equivalent) with up to -6.00D of refractive astigmatism, with a spherical equivalent up to -15.00D as measured by manifest subjective refraction.
- Subjects who had less than 0.75 D of difference in the preoperative manifest spherical equivalent and cycloplegic spherical equivalent subjective refractions.
(Manifest subjective refractions adjusted for optical infinity were used.)
- High contrast, manifest best spectacle-corrected distance logMAR visual acuity correctable to at least 0.3 in both eyes, and must not differ between eyes by more than 1 line (5 letters).
- Contact lens wearers must have 2 Orbscan measurements and 2 manifest subjective refractions taken preoperatively at least 1 week apart.
- Contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 2 weeks prior to the preoperative evaluation.
Exclusion
- Subjects with uncorrected visual acuity better than 20/40 (Snellen) or 0.3 logMAR
- Subjects who were immuno-compromised or had a diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that increased the risk to the subject or could have confounded the outcomes of this study.
- Subjects with uncontrolled glaucoma or glaucoma who were under treatment in the study eye or with ocular hypertension.
- Subjects who demonstrated evidence of retinal vascular disease.
- Subjects who have an ocular muscle disorder including strabismus or nystagmus, or other disorders that affected fixation.
- Subjects who were at risk for angle closure or who had a potentially occludable angle, as evidenced by a shallow anterior chamber on slit lamp exam, confirmed by gonioscopy as deemed necessary by the study Investigator.
- Subjects who had undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes.
- Subjects who were taking systemic medications likely to affect wound healing such as corticosteroids or anti-metabolites or any other medications that may increase the risk to the subject or confound the outcomes of this study.
- Subjects for whom the combination of their preoperative corneal thickness and the planned operative parameters for the LASIK procedure could have resulted in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Technolas 217z Excimer Laser
Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.
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LASIK correction of myopia and myopic astigmatism
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
時間枠:3 months
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3 months
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Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia
時間枠:3 months
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Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis.
Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina.
Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder.
It is expressed in diopters (D).
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3 months
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Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity
時間枠:Baseline, 3 months
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Mean change in best-corrected high contrast distance visual acuity.
Corrected means spectacle corrected.
Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity.
The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters.
The total number of correct letters were recorded.
A decrease in the number of correct letters indicates a decrease in visual acuity.
Acuity was averaged across visits.
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Baseline, 3 months
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Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
時間枠:3 months
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3 months
|
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Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder
時間枠:3 months
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Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis.
Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina.
Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder.
It is expressed in diopters (D).
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3 months
|
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Percentage of Eyes That Had High Contrast Best Spectacle Corrected Visual Acuity (HCBSCVA) of 20/20 or Better at Baseline Had a Visual Outcome Worse Than 20/40 at 3 Months
時間枠:3 months
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Corrected means spectacle corrected.
Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity.
The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters.
The total number of correct letters were recorded.
A decrease in the number of correct letters indicates a decrease in visual acuity.
Acuity was averaged across visits.
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3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage Change From Baseline in Higher Order Aberrations.
時間枠:Baseline, 3 months
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The aberrations in the eye's optical system were measured over the entire pupil by the Bausch & Lomb Zywave II WaveFront Aberrometer, a Hartmann-Shack type device.
The pupil should have been at least 6 mm in diameter using 2.5% phenylephrine as a dilating agent to maximize the pupil diameter and hence the amount of wavefront information collected by the Zywave II.
The wavefront data was then fitted with Zernike polynomials representing the 2nd, 3rd, 4th and 5th order Zernike terms.
These terms represent the wavefront aberration of the eye.
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Baseline, 3 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Mark Cohen, MD、Lasik MD
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年8月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2008年10月8日
QC基準を満たした最初の提出物
2008年10月8日
最初の投稿 (見積もり)
2008年10月9日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月11日
QC基準を満たした最後の更新が送信されました
2020年8月24日
最終確認日
2020年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。