A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients
2019年12月17日 更新者：Refocus Group, Inc.
A Prospective, Multicenter Clinical Trial of the VisAbility Micro Insert System for Improvement of Near Visual Acuity In Presbyopic Patients
The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro Insert System for the improvement of near visual acuity in presbyopic patients.
調査の概要
詳細な説明
The objective of this study is to evaluate the safety and effectiveness of the VisAbility Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This is a prospective clinical study that enrolled a total of 360 subjects ranging in age between 45 and 60 years of age at 13 clinical sites. Subjects were implanted with the VisAbility Implant model SGP-046 in the primary eye and then in the fellow eye no sooner than 14 days later. Subjects were examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.
The study also included a 60 subject randomized controlled sub-study at 3 investigation sites. Sub-study subjects were randomized (1:1 ratio) to a surgery group or a control group. Subjects randomized to the surgery group underwent surgery and were followed for 24 months in the same manner as the larger non-randomized surgical group. Subjects randomized to the control group were observed for 6 months, and were then eligible to undergo surgery after completion of this 6-month observation period.
The primary endpoint is the achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.
This endpoint is evaluated against two objectives, a) 75% or more of primary eyes achieve the effectiveness endpoint at 12 months postoperative and b) the percentage of primary eyes achieving the effectiveness endpoint at 6 months postoperative (6-month responder rate) is higher than the percentage in the randomized control group.
Safety data analyses were performed and separate summaries are provided for primary and all eyes. Descriptive statistics on the following attributes are provided for; BCDVA, IOP, Slit lamp findings, Fundus exam findings, and Adverse events.
研究の種類
介入
入学 (実際)
365
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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California
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Orange、California、アメリカ、92868
- Coastal Vision
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San Diego、California、アメリカ、92122
- Gordon Weiss Vision Institute
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Hawaii
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Honolulu、Hawaii、アメリカ、96814
- Aloha Laser Vision
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Illinois
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Des Plaines、Illinois、アメリカ、60016
- The Midwest Center for Sight
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Indiana
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Indianapolis、Indiana、アメリカ、46256
- Eye Surgeons Of Indiana PC
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Kentucky
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Louisville、Kentucky、アメリカ、40206
- Eye Care Institute
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Minnesota
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Bloomington、Minnesota、アメリカ、55420
- Chu Vision Institute
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New York
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Wantagh、New York、アメリカ、11793
- South Shore Eye Care LLP
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Wantagh、New York、アメリカ、11793
- South Shore Eye Care, LLP
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North Carolina
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Greensboro、North Carolina、アメリカ、27401
- Physicians Protocol
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Ohio
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Westerville、Ohio、アメリカ、43082
- Comprehensive EyeCare of Central Ohio
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Pennsylvania
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Wilkes-Barre、Pennsylvania、アメリカ、18702
- Bucci Laser Vision
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Texas
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Dallas、Texas、アメリカ、75242
- Key Whitman Eye Center
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San Antonio、Texas、アメリカ、78212
- Braverman-Terry-Oei Eye Associates
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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
45年～60年 (大人)
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 must have a Best Corrected Distance Visual Acuity (BCDVA) of 20/20 in each eye
- Subjects must have a Distance Corrected Near Visual Acuity (DCNVA) @ 40 cm of 20/50, 20/63, or 20/80 in each eye
- Subjects must have an Uncorrected Near Visual Acuity (UCNVA) @ 40 cm of 20/50, 20/63, or 20/80 in each eye
- Subject's Preoperative Manifest Refraction Spherical Equivalent (MRSE) in each eye must be -0.75 to +0.50 diopters with no more than 1.00 diopter of astigmatism.
- Cycloplegic refraction spherical equivalent (CRSE) difference from MRSE should be less than or equal to 0.50 diopters.
- Subjects must require a minimum add of +1.25 or greater to read 20/20 at near (40 cm).
- Subjects must be alert, mentally competent, and able to understand and comply with the requirements of the clinical study, and be personally motivated to abide by the requirements and restrictions of the clinical study. Patients must be available for the follow-up period.
- Subjects must be able to provide written informed consent
Exclusion Criteria:
- Pupil has a baseline percent change from scotopic to photopic of less than 30% or an absolute difference of less than 1.00 mm between scotopic and photopic pupil size as measured by the NeurOptics Pupillometer
- Subjects with ocular inflammation, chronic uveitis, or other recurrent anterior or posterior segment inflammatory conditions in either eye; subjects with any ocular or systemic disease(s) posing a significant risk for ocular inflammation including but not limited to, autoimmune disorders (e.g. rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, ulcerative colitis, Chron's disease, psoriasis, sarcoidosis, Bechet's disease), infections (toxoplasmosis, cat-scratch fever, West Nile virus, syphilis, tuberculosis, herpes zoster, herpes simplex, adenovirus), ocular trauma or gout.
- Subjects with scleral thickness of less than 530 microns as measured 3.5 to 40.00 mm posterior to the superior temporal quadrant limbus in either eye.
- Subjects with a history of any prior intraocular procedure (e.g. corneal transplant, filtering procedures for glaucoma, vitrectomy, retinal detachment repair, cataract surgery) or any prior refractive procedure (e.g. LASIK (laser in situ keratomileusis), surface excimer, or incisional surgery) in either eye.
- Subjects with any history of prior extraocular muscle surgery or orbital surgery.
- Subjects with chronic ocular disease including but not limited to corneal pathology, primary or secondary glaucoma, iritis, herpes simplex, uveitis, trachoma, ocular pemphigoid, Sjogrens disease, uveal melanoma, Thyroid Related Immune Orbitopathy or clinical significant retinal pathology in either eye.
- Subjects with any acute ocular disease that has not been completely treated and resolved for at least three months such as conjunctivitis, blepharitis, chalazion, corneal abrasion or keratitis in either eye.
- Subjects with chronic systemic diseases which may affect the eye, including but not limited to diabetes, ulcerative colitis, systemic lupus erythematosus, Chron's disease, collagen vascular disease, rheumatoid arthritis, any bleeding diathesis, or systemic manifestations of HIV/AIDS. Any other uncontrolled systemic disease (e.g. hypertension, cancer, etc.) that could compromise the patient's participation.
- Use of any medication such as Coumadin, that could make the surgical procedure more difficult. Subjects using Coumadin, aspirin, or NSAID (non-steroidal anti inflammatory drug) medications under orders from a doctor must be able to provide written approval from the treating doctor for discontinuing this medication at least 10 days prior to surgery.
- Subjects with chronic ocular surface disease, including but not limited to subjects with a prior diagnosis of chronic dry eye syndrome based on tests such as but not limited to, corneal or conjunctival staining, Ocular surface Disease Index symptom score or Schirmer tear testing.
- Subjects who are allergic to any medications used in the protocol
- Subjects who are pregnant, lactating, or of child-bearing age adn not practicing a medically approved method of birth control.
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Implantation-Non-Randomized
Subjects are not participants in the randomized sub-study.
VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
|
Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
|
実験的：Implantation-Randomized
Subjects are participants in the randomized sub-study.
Subjects were randomized to the Immediate Treatment group.
VisAbility micro inserts surgically implanted in the eyes.
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
|
Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
|
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介入なし：Deferred Implantation-Randomized
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
Subjects were randomized to the Deferred Treatment group are observed for 6 months.
Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.
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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 |
|---|---|---|
|
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters.
時間枠：From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
|
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better and Gain of At Least 10 Letters at 24 months for the primary eye.
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From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy
時間枠：From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.
|
The randomized surgery group is defined as successful if the percentage of primary eyes achieving Distance Corrected Near Visual Acuity at 40 centimeters of 20/40 of Better and Gain of 10 Letters more at 6 months postoperative (i.e.
6-month responder rate) is higher than the percentage in the randomized control group.
|
From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.
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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。
スポンサー
捜査官
- スタディディレクター：Selene Burke, O.D.、V.P. Clinical Affairs
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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 (実際)
2014年11月15日
一次修了 (実際)
2018年4月13日
研究の完了 (実際)
2018年4月13日
試験登録日
最初に提出
2015年2月17日
QC基準を満たした最初の提出物
2015年2月23日
最初の投稿 (見積もり)
2015年3月2日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月6日
QC基準を満たした最後の更新が送信されました
2019年12月17日
最終確認日
2019年12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。