CorVision® 4-year Follow-up (CorVision4yFU)
28 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
95
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Zlín, Tcheca, 760 01
- Gemini Eye Clinic
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Uncorrected Near Visual Acuity of 0.3 logMAR or better
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinically significant corneal haze occurrence
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Monocular Uncorrected Near Visual Acuity at Best Reading Distance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
27 de junho de 2025
Conclusão Primária (Real)
25 de novembro de 2025
Conclusão do estudo (Real)
25 de novembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
15 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
3 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CMG-PRT-002-1
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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