Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients

17 grudnia 2019 zaktualizowane przez: Refocus Group, Inc.

A Prospective, Multicenter Clinical Trial of the VisAbility Micro Insert System for Improvement of Near Visual Acuity In Presbyopic Patients

The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro Insert System for the improvement of near visual acuity in presbyopic patients.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The objective of this study is to evaluate the safety and effectiveness of the VisAbility Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This is a prospective clinical study that enrolled a total of 360 subjects ranging in age between 45 and 60 years of age at 13 clinical sites. Subjects were implanted with the VisAbility Implant model SGP-046 in the primary eye and then in the fellow eye no sooner than 14 days later. Subjects were examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.

The study also included a 60 subject randomized controlled sub-study at 3 investigation sites. Sub-study subjects were randomized (1:1 ratio) to a surgery group or a control group. Subjects randomized to the surgery group underwent surgery and were followed for 24 months in the same manner as the larger non-randomized surgical group. Subjects randomized to the control group were observed for 6 months, and were then eligible to undergo surgery after completion of this 6-month observation period.

The primary endpoint is the achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.

This endpoint is evaluated against two objectives, a) 75% or more of primary eyes achieve the effectiveness endpoint at 12 months postoperative and b) the percentage of primary eyes achieving the effectiveness endpoint at 6 months postoperative (6-month responder rate) is higher than the percentage in the randomized control group.

Safety data analyses were performed and separate summaries are provided for primary and all eyes. Descriptive statistics on the following attributes are provided for; BCDVA, IOP, Slit lamp findings, Fundus exam findings, and Adverse events.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

365

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Orange, California, Stany Zjednoczone, 92868
        • Coastal Vision
      • San Diego, California, Stany Zjednoczone, 92122
        • Gordon Weiss Vision Institute
    • Hawaii
      • Honolulu, Hawaii, Stany Zjednoczone, 96814
        • Aloha Laser Vision
    • Illinois
      • Des Plaines, Illinois, Stany Zjednoczone, 60016
        • The Midwest Center for Sight
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46256
        • Eye Surgeons Of Indiana PC
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40206
        • Eye Care Institute
    • Minnesota
      • Bloomington, Minnesota, Stany Zjednoczone, 55420
        • Chu Vision Institute
    • New York
      • Wantagh, New York, Stany Zjednoczone, 11793
        • South Shore Eye Care LLP
      • Wantagh, New York, Stany Zjednoczone, 11793
        • South Shore Eye Care, LLP
    • North Carolina
      • Greensboro, North Carolina, Stany Zjednoczone, 27401
        • Physicians Protocol
    • Ohio
      • Westerville, Ohio, Stany Zjednoczone, 43082
        • Comprehensive EyeCare of Central Ohio
    • Pennsylvania
      • Wilkes-Barre, Pennsylvania, Stany Zjednoczone, 18702
        • Bucci Laser Vision
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75242
        • Key Whitman Eye Center
      • San Antonio, Texas, Stany Zjednoczone, 78212
        • Braverman-Terry-Oei Eye Associates

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

45 lat do 60 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Subjects must have a Best Corrected Distance Visual Acuity (BCDVA) of 20/20 in each eye
  • Subjects must have a Distance Corrected Near Visual Acuity (DCNVA) @ 40 cm of 20/50, 20/63, or 20/80 in each eye
  • Subjects must have an Uncorrected Near Visual Acuity (UCNVA) @ 40 cm of 20/50, 20/63, or 20/80 in each eye
  • Subject's Preoperative Manifest Refraction Spherical Equivalent (MRSE) in each eye must be -0.75 to +0.50 diopters with no more than 1.00 diopter of astigmatism.
  • Cycloplegic refraction spherical equivalent (CRSE) difference from MRSE should be less than or equal to 0.50 diopters.
  • Subjects must require a minimum add of +1.25 or greater to read 20/20 at near (40 cm).
  • Subjects must be alert, mentally competent, and able to understand and comply with the requirements of the clinical study, and be personally motivated to abide by the requirements and restrictions of the clinical study. Patients must be available for the follow-up period.
  • Subjects must be able to provide written informed consent

Exclusion Criteria:

  • Pupil has a baseline percent change from scotopic to photopic of less than 30% or an absolute difference of less than 1.00 mm between scotopic and photopic pupil size as measured by the NeurOptics Pupillometer
  • Subjects with ocular inflammation, chronic uveitis, or other recurrent anterior or posterior segment inflammatory conditions in either eye; subjects with any ocular or systemic disease(s) posing a significant risk for ocular inflammation including but not limited to, autoimmune disorders (e.g. rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, ulcerative colitis, Chron's disease, psoriasis, sarcoidosis, Bechet's disease), infections (toxoplasmosis, cat-scratch fever, West Nile virus, syphilis, tuberculosis, herpes zoster, herpes simplex, adenovirus), ocular trauma or gout.
  • Subjects with scleral thickness of less than 530 microns as measured 3.5 to 40.00 mm posterior to the superior temporal quadrant limbus in either eye.
  • Subjects with a history of any prior intraocular procedure (e.g. corneal transplant, filtering procedures for glaucoma, vitrectomy, retinal detachment repair, cataract surgery) or any prior refractive procedure (e.g. LASIK (laser in situ keratomileusis), surface excimer, or incisional surgery) in either eye.
  • Subjects with any history of prior extraocular muscle surgery or orbital surgery.
  • Subjects with chronic ocular disease including but not limited to corneal pathology, primary or secondary glaucoma, iritis, herpes simplex, uveitis, trachoma, ocular pemphigoid, Sjogrens disease, uveal melanoma, Thyroid Related Immune Orbitopathy or clinical significant retinal pathology in either eye.
  • Subjects with any acute ocular disease that has not been completely treated and resolved for at least three months such as conjunctivitis, blepharitis, chalazion, corneal abrasion or keratitis in either eye.
  • Subjects with chronic systemic diseases which may affect the eye, including but not limited to diabetes, ulcerative colitis, systemic lupus erythematosus, Chron's disease, collagen vascular disease, rheumatoid arthritis, any bleeding diathesis, or systemic manifestations of HIV/AIDS. Any other uncontrolled systemic disease (e.g. hypertension, cancer, etc.) that could compromise the patient's participation.
  • Use of any medication such as Coumadin, that could make the surgical procedure more difficult. Subjects using Coumadin, aspirin, or NSAID (non-steroidal anti inflammatory drug) medications under orders from a doctor must be able to provide written approval from the treating doctor for discontinuing this medication at least 10 days prior to surgery.
  • Subjects with chronic ocular surface disease, including but not limited to subjects with a prior diagnosis of chronic dry eye syndrome based on tests such as but not limited to, corneal or conjunctival staining, Ocular surface Disease Index symptom score or Schirmer tear testing.
  • Subjects who are allergic to any medications used in the protocol
  • Subjects who are pregnant, lactating, or of child-bearing age adn not practicing a medically approved method of birth control.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Implantation-Non-Randomized
Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
Urządzenie: VisAbility Micro Insert
Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
Eksperymentalny: Implantation-Randomized
Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
Urządzenie: VisAbility Micro Insert
Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
Brak interwencji: Deferred Implantation-Randomized
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters.
Ramy czasowe: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better and Gain of At Least 10 Letters at 24 months for the primary eye.
From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy
Ramy czasowe: From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.
The randomized surgery group is defined as successful if the percentage of primary eyes achieving Distance Corrected Near Visual Acuity at 40 centimeters of 20/40 of Better and Gain of 10 Letters more at 6 months postoperative (i.e. 6-month responder rate) is higher than the percentage in the randomized control group.
From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Refocus Group, Inc.

Śledczy

  • Dyrektor Studium: Selene Burke, O.D., V.P. Clinical Affairs

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 listopada 2014

Zakończenie podstawowe (Rzeczywisty)

13 kwietnia 2018

Ukończenie studiów (Rzeczywisty)

13 kwietnia 2018

Daty rejestracji na studia

Pierwszy przesłany

17 lutego 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 lutego 2015

Pierwszy wysłany (Oszacować)

2 marca 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 stycznia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 grudnia 2019

Ostatnia weryfikacja

1 grudnia 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • VIS-2014

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj