CorVision® 4-year Follow-up (CorVision4yFU)
2026년 5월 28일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
관찰
등록 (실제)
95
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Zlín, 체코, 760 01
- Gemini Eye Clinic
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Uncorrected Near Visual Acuity of 0.3 logMAR or better
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Clinically significant corneal haze occurrence
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Monocular Uncorrected Near Visual Acuity at Best Reading Distance
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 6월 27일
기본 완료 (실제)
2025년 11월 25일
연구 완료 (실제)
2025년 11월 25일
연구 등록 날짜
최초 제출
2026년 5월 15일
QC 기준을 충족하는 최초 제출
2026년 5월 28일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 28일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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