CorVision® 4-year Follow-up (CorVision4yFU)
2026年5月28日 更新者：Katerina Klimesova、Gemini Eye Clinic
Four Years Extended Follow-Up on CorVision® Bioengineered Corneal Microlens: Safety and Efficacy
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment.
Approximately 100 patients in the Czech Republic will participate in this study.
The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL).
The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed.
This visit will correspond to the 4-year follow-up visit of the original clinical trial.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
95
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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Zlín、チェコ、760 01
- Gemini Eye Clinic
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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
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The target population are patients who suffered from presbyopia and underwent the original CorVision clinical study are medically suitable to undertake the current clinical study investigation.
説明
Inclusion Criteria:
- Subjects must have undergone implantation of CorVision microlens under study protocol CMG-PRT-002.
- Provide informed consent
- Willing to participate in the ophthalmological examinations
Exclusion Criteria:
- Patients with severe ocular or general disorders that would prevent them from completed the visit.
- Patients not being able to understand and give informed consent.
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
コホートと介入
グループ/コホート |
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Post-presbyopia correction with unilaterally implanted microlens
Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002.
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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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Uncorrected Near Visual Acuity of 0.3 logMAR or better
時間枠：At least 4 years after the implantation
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More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
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At least 4 years after the implantation
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Implant removal
時間枠：At least 4 years after the implantation
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The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.
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At least 4 years after the implantation
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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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Clinically significant corneal haze occurrence
時間枠：At least 4 years after the implantation
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Clinically significant corneal haze is defined as any new stromal clouding in or near the laser-created pocket that leads to a reduction in central corneal clarity/transparency, is visible upon slit-lamp examination, and is graded as ≥ 2 on a standardized corneal haze grading scale.
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At least 4 years after the implantation
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Monocular Uncorrected Near Visual Acuity at Best Reading Distance
時間枠：At least 4 years after the implantation
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Change in monocular uncorrected near visual acuity and best reading distance over time
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At least 4 years after the implantation
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Monocular and Binocular Uncorrected Near Visual Acuity at 40 cm
時間枠：At least 4 years after the implantation
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Change in monocular and binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm.
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At least 4 years after the implantation
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Monocular and Binocular Distance Corrected Near Visual Acuity
時間枠：At least 4 years after the implantation
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Change in monocular and binocular Distance Corrected Near Visual Acuity (DCNVA).
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At least 4 years after the implantation
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Monocular and Binocular Corrected Near Visual Acuity
時間枠：At least 4 years after the implantation
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Change in monocular and binocular Corrected Near Visual Acuity (CNVA) over time.
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At least 4 years after the implantation
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Monocular and Binocular Uncorrected Intermediate Visual Acuity (UIVA)
時間枠：At least 4 years after the implantation
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Change in monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) over time.
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At least 4 years after the implantation
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Monocular and Binocular Distance Corrected Intermediate Visual Acuity
時間枠：At least 4 years after the implantation
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Change in monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) over time.
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At least 4 years after the implantation
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Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA)
時間枠：At least 4 years after the implantation
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Change in monocular Uncorrected Distance Visual Acuity (UDVA) over time.
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At least 4 years after the implantation
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Monocular and Binocular Corrected Distance Visual Acuity (CDVA)
時間枠：At least 4 years after the implantation
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Change in monocular and binocular Corrected Distance Visual Acuity (CDVA) over time.
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At least 4 years after the implantation
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Objective refraction
時間枠：At least 4 years after the implantation
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Change in objective refractive sphere and cylinder magnitude measured by autorefractometry.
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At least 4 years after the implantation
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Subjective refraction
時間枠：At least 4 years after the implantation
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Change in manifest refractive sphere and cylinder magnitude, measured in diopters (D).
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At least 4 years after the implantation
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Near addition
時間枠：At least 4 years after the implantation
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Change in near addition values over time.
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At least 4 years after the implantation
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Corneal Keratometry Measurements (K1, K2, and Kmean)
時間枠：At least 4 years after the implantation
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Change in corneal keratometry values, including K1, K2, and mean keratometry (Kmean), as measured by corneal topography over time. Change in keratometry K1, K2 and Kmean measured in diopters over time. |
At least 4 years after the implantation
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Central Corneal Thickness (Pachymetry) Measurement
時間枠：At least 4 years after the implantation
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Change in central corneal thickness as measured by corneal pachymetry over time.
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At least 4 years after the implantation
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Endothelial Cell Density (Study Eye)
時間枠：At least 4 years after the implantation
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Change in endothelial cell density over time.
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At least 4 years after the implantation
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Intraocular Pressure (Study Eye)
時間枠：At least 4 years after the implantation
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Change in intraocular pressure over time.
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At least 4 years after the implantation
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Tear Film Break-Up Time (TBUT) Test
時間枠：At least 4 years after the implantation
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Change in tear film stability as measured by Tear Film Break-Up Time (TBUT) in units of seconds.
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At least 4 years after the implantation
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Tear Production (Schirmer Test)
時間枠：At least 4 years after the implantation
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Change in tear production as measured by the Schirmer test in units of mm.
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At least 4 years after the implantation
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Corneal Thickness Measurement Using Optical Coherence Tomography (OCT)
時間枠：At least 4 years after the implantation
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Change in corneal thickness measured at the corneal center in μm.
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At least 4 years after the implantation
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Abnormal findings at OCT
時間枠：At least 4 years after the implantation
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Incidence of abnormal findings on OCT.
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At least 4 years after the implantation
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Slit-lamp findings
時間枠：At least 4 years after the implantation
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Incidence of abnormal slit lamp findings (eyelid, conjunctiva, epithelium, stroma, central cornea clarity, cornea neovascularization, anterior chamber, iris, lens).
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At least 4 years after the implantation
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Contrast sensitivity
時間枠：At least 4 years after the implantation
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Determination of contrast sensitivity measured by CSV 1000 (Vector Vision) (changes from the pre-operative to the post-operative state and its stability over time will be investigated).
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At least 4 years after the implantation
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Defocus curve
時間枠：At least 4 years after the implantation
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Change in visual acuity measured at different defocus vergence levels during monocular defocus curve testing over time.
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At least 4 years after the implantation
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Aberrometry measurements using iTrace
時間枠：At least 4 years after the implantation
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Change in the total higher order aberrations (HOA) assessed by iTrace.
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At least 4 years after the implantation
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Subjective questionnaire QoV - patient satisfaction
時間枠：At least 4 years after the implantation
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Evaluation of patient satisfaction assessed on a scale
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At least 4 years after the implantation
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Subjective questionnaire QoV
時間枠：At least 4 years after the implantation
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Evaluation of patient satisfaction as assessed using the Quality of Vision (QoV) questionnaire scoring scale.
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At least 4 years after the implantation
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Adverse events incidence
時間枠：At least 4 years after the implantation
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Intraoperative and adverse events at each time point (numbers and percentages)
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At least 4 years after the implantation
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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。
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)
2025年6月27日
一次修了 (実際)
2025年11月25日
研究の完了 (実際)
2025年11月25日
試験登録日
最初に提出
2026年5月15日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5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。