CorVision® 4-year Follow-up (CorVision4yFU)
28. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
95
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Zlín, Tjekkiet, 760 01
- Gemini Eye Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Uncorrected Near Visual Acuity of 0.3 logMAR or better
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinically significant corneal haze occurrence
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Monocular Uncorrected Near Visual Acuity at Best Reading Distance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. juni 2025
Primær færdiggørelse (Faktiske)
25. november 2025
Studieafslutning (Faktiske)
25. november 2025
Datoer for studieregistrering
Først indsendt
15. maj 2026
Først indsendt, der opfyldte QC-kriterier
28. maj 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CMG-PRT-002-1
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