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CorVision® 4-year Follow-up (CorVision4yFU)

28 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

95

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Tjeckien
      • Zlín, Tjeckien, 760 01
        • Gemini Eye Clinic

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Post-presbyopia correction with unilaterally implanted microlens
Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Uncorrected Near Visual Acuity of 0.3 logMAR or better
Tidsram: At least 4 years after the implantation
More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
At least 4 years after the implantation
Implant removal
Tidsram: At least 4 years after the implantation
The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.
At least 4 years after the implantation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinically significant corneal haze occurrence
Tidsram: At least 4 years after the implantation
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.
At least 4 years after the implantation

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Monocular Uncorrected Near Visual Acuity at Best Reading Distance
Tidsram: At least 4 years after the implantation
Change in monocular uncorrected near visual acuity and best reading distance over time
At least 4 years after the implantation
Monocular and Binocular Uncorrected Near Visual Acuity at 40 cm
Tidsram: At least 4 years after the implantation
Change in monocular and binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm.
At least 4 years after the implantation
Monocular and Binocular Distance Corrected Near Visual Acuity
Tidsram: At least 4 years after the implantation
Change in monocular and binocular Distance Corrected Near Visual Acuity (DCNVA).
At least 4 years after the implantation
Monocular and Binocular Corrected Near Visual Acuity
Tidsram: At least 4 years after the implantation
Change in monocular and binocular Corrected Near Visual Acuity (CNVA) over time.
At least 4 years after the implantation
Monocular and Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Tidsram: At least 4 years after the implantation
Change in monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) over time.
At least 4 years after the implantation
Monocular and Binocular Distance Corrected Intermediate Visual Acuity
Tidsram: At least 4 years after the implantation
Change in monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) over time.
At least 4 years after the implantation
Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA)
Tidsram: At least 4 years after the implantation
Change in monocular Uncorrected Distance Visual Acuity (UDVA) over time.
At least 4 years after the implantation
Monocular and Binocular Corrected Distance Visual Acuity (CDVA)
Tidsram: At least 4 years after the implantation
Change in monocular and binocular Corrected Distance Visual Acuity (CDVA) over time.
At least 4 years after the implantation
Objective refraction
Tidsram: At least 4 years after the implantation
Change in objective refractive sphere and cylinder magnitude measured by autorefractometry.
At least 4 years after the implantation
Subjective refraction
Tidsram: At least 4 years after the implantation
Change in manifest refractive sphere and cylinder magnitude, measured in diopters (D).
At least 4 years after the implantation
Near addition
Tidsram: At least 4 years after the implantation
Change in near addition values over time.
At least 4 years after the implantation
Corneal Keratometry Measurements (K1, K2, and Kmean)
Tidsram: At least 4 years after the implantation

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
Central Corneal Thickness (Pachymetry) Measurement
Tidsram: At least 4 years after the implantation
Change in central corneal thickness as measured by corneal pachymetry over time.
At least 4 years after the implantation
Endothelial Cell Density (Study Eye)
Tidsram: At least 4 years after the implantation
Change in endothelial cell density over time.
At least 4 years after the implantation
Intraocular Pressure (Study Eye)
Tidsram: At least 4 years after the implantation
Change in intraocular pressure over time.
At least 4 years after the implantation
Tear Film Break-Up Time (TBUT) Test
Tidsram: At least 4 years after the implantation
Change in tear film stability as measured by Tear Film Break-Up Time (TBUT) in units of seconds.
At least 4 years after the implantation
Tear Production (Schirmer Test)
Tidsram: At least 4 years after the implantation
Change in tear production as measured by the Schirmer test in units of mm.
At least 4 years after the implantation
Corneal Thickness Measurement Using Optical Coherence Tomography (OCT)
Tidsram: At least 4 years after the implantation
Change in corneal thickness measured at the corneal center in μm.
At least 4 years after the implantation
Abnormal findings at OCT
Tidsram: At least 4 years after the implantation
Incidence of abnormal findings on OCT.
At least 4 years after the implantation
Slit-lamp findings
Tidsram: At least 4 years after the implantation
Incidence of abnormal slit lamp findings (eyelid, conjunctiva, epithelium, stroma, central cornea clarity, cornea neovascularization, anterior chamber, iris, lens).
At least 4 years after the implantation
Contrast sensitivity
Tidsram: At least 4 years after the implantation
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).
At least 4 years after the implantation
Defocus curve
Tidsram: At least 4 years after the implantation
Change in visual acuity measured at different defocus vergence levels during monocular defocus curve testing over time.
At least 4 years after the implantation
Aberrometry measurements using iTrace
Tidsram: At least 4 years after the implantation
Change in the total higher order aberrations (HOA) assessed by iTrace.
At least 4 years after the implantation
Subjective questionnaire QoV - patient satisfaction
Tidsram: At least 4 years after the implantation
Evaluation of patient satisfaction assessed on a scale
At least 4 years after the implantation
Subjective questionnaire QoV
Tidsram: At least 4 years after the implantation
Evaluation of patient satisfaction as assessed using the Quality of Vision (QoV) questionnaire scoring scale.
At least 4 years after the implantation
Adverse events incidence
Tidsram: At least 4 years after the implantation
Intraoperative and adverse events at each time point (numbers and percentages)
At least 4 years after the implantation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Gemini Eye Clinic

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 juni 2025

Primärt slutförande (Faktisk)

25 november 2025

Avslutad studie (Faktisk)

25 november 2025

Studieregistreringsdatum

Först inskickad

15 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CMG-PRT-002-1

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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