CorVision® 4-year Follow-up (CorVision4yFU)
28 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
95
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Zlín, Cechia, 760 01
- Gemini Eye Clinic
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Uncorrected Near Visual Acuity of 0.3 logMAR or better
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinically significant corneal haze occurrence
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Monocular Uncorrected Near Visual Acuity at Best Reading Distance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 giugno 2025
Completamento primario (Effettivo)
25 novembre 2025
Completamento dello studio (Effettivo)
25 novembre 2025
Date di iscrizione allo studio
Primo inviato
15 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 maggio 2026
Primo Inserito (Effettivo)
3 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CMG-PRT-002-1
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .