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Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia (Ambly4Home)

17 września 2026 zaktualizowane przez: Catarina Mateus, PhD, Polytechnic Institute of Porto

The goal of this clinical trial is to evaluate a home-based augmented reality-based binocular therapy designed to improve visual function in adults aged 18 to 40 years with unilateral anisometropic amblyopia, commonly called "lazy eye." The therapy is designed to be used during everyday activities, allowing visual training to be integrated into the participant's normal home routine.

The main questions this study aims to answer are:

Does the Ambly4Home augmented reality-based binocular therapy improve visual acuity in the amblyopic eye and binocular vision compared with placebo visual training?
Are any improvements in visual function maintained 6 months after the treatment has ended?
Is the treatment associated with changes in other measures of visual function, retinal structure and function, and visual brain function?

Participants will be randomly assigned to receive either active binocular therapy or placebo visual training. Both groups will use the same mixed-reality device, follow the same training schedule, and carry out similar daily activities while viewing their real-world surroundings through the device. In the active treatment, the image presented to the amblyopic eye will remain close to the natural scene, while the contrast of the image presented to the stronger eye will be selectively lowered. This gives the amblyopic eye a relative visual advantage, helping to rebalance the input from the two eyes and encouraging them to work together.

In the placebo group, participants will use the same device under the same conditions, but without the selective contrast reduction used in the active treatment. This comparison will allow researchers to isolate the specific effect of selectively lowering the contrast seen by the stronger eye.

Participants will:

Complete 40-minute training sessions four times per week for 10 weeks.
Learn how to use the system in a clinical setting before continuing the training at home.
Attend assessment visits before treatment, after 10 weeks of treatment, and 6 months after treatment has ended.
Complete tests of visual acuity, depth perception, suppression between the eyes, and contrast sensitivity, as well as retinal imaging, retinal function testing, and brain imaging.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Amblyopia is a neurodevelopmental disorder characterized not only by reduced visual acuity in the amblyopic eye but also by abnormal interaction between the two eyes, including interocular suppression and impaired binocular integration. Although treatment has traditionally focused on childhood, evidence of residual visual plasticity in adults has supported the development of binocular and dichoptic approaches aimed at restoring a more balanced contribution from both eyes.

Dichoptic therapy simultaneously stimulates both eyes while presenting different visual inputs to each eye. A common strategy is to reduce the strength of the image presented to the stronger eye, allowing the amblyopic eye to contribute more effectively during binocular viewing. This approach differs from conventional occlusion because visual information from both eyes remains available throughout treatment.

The intervention evaluated in this study is designed to adapt this therapeutic principle to the daily life of adults with amblyopia. In contrast to fully immersive virtual reality approaches that require participants to interrupt their usual activities and engage in dedicated virtual tasks or games, the intervention uses a Meta Quest 3 mixed-reality headset operating in passthrough mode. Participants can therefore continue to view and interact with their real-world environment while controlled visual processing is applied separately to each eye. The intervention is intended to integrate binocular visual rehabilitation into functional activities performed in the home environment.

During active treatment, the real-world scene presented to the amblyopic eye is preserved as close as possible to natural viewing conditions. The dominant eye receives the same spatially corresponding scene, but with a controlled reduction in contrast. This contrast manipulation reduces the functional advantage of the dominant eye without completely removing its visual information, creating a relative visual advantage for the amblyopic eye and encouraging its more active participation during binocular viewing. The intervention therefore aims to progressively rebalance the contribution of the two eyes rather than replace binocular vision with monocular viewing.

The degree of contrast modulation will be individualized according to the participant's visual function and adjusted throughout treatment according to visual performance. As visual function improves, the contrast difference between the eyes can be progressively reduced, bringing the visual inputs closer to natural binocular viewing conditions. This adaptive approach is intended to maintain an appropriate therapeutic challenge while avoiding unnecessary or excessive penalization of the dominant eye.

The study uses a randomized, placebo-controlled design in which both groups use the same mixed-reality device and follow the same training routine. The placebo condition preserves the device experience, duration, tasks, instructions, and home-use context but does not include the selective interocular contrast manipulation that produces active binocular rebalancing. This design allows the specific effect of the dichoptic treatment mechanism to be distinguished from nonspecific effects related to repeated visual activity, familiarity with the device, attention, and treatment expectations.

The home-based intervention is also designed to support objective monitoring of treatment exposure. Information such as session completion, effective training duration, interruptions, visual settings, task performance, adherence, and tolerability may be recorded to characterize the actual treatment dose and support individualized progression. Functional activities will be selected according to the participant's visual ability and safety, allowing the difficulty of the training to increase gradually as adaptation and visual performance improve.

In addition to determining the clinical effect of the binocular intervention, the study uses a multimodal assessment approach to characterize visual, retinal, and cortical changes associated with treatment and to investigate whether any improvements persist after treatment has ended. This approach is intended to provide a broader understanding of the functional and neurobiological response to home-based augmented reality binocular rehabilitation in adults with anisometropic amblyopia.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

Faza

Nie dotyczy

Kontakty i lokalizacje

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

Kontakt w sprawie studiów

Nazwa: Rúben Magalhães, MSc
Numer telefonu: +351 968918180
E-mail: rjcm@ess.ipp.pt

Kopia zapasowa kontaktu do badania

Nazwa: Catarina A Mateus, PhD
Numer telefonu: +351 913474780
E-mail: cms@ess.ipp.pt

Lokalizacje studiów

Portugalia
- Coimbra District
  - Coimbra, Coimbra District, Portugalia, 3000-548
    - Rekrutacyjny
    - Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), University of Coimbra
    - Główny śledczy:
      
      Miguel Castelo-Branco, MD, PhD
    - Pod-śledczy:
      
      João Castelhano, PhD
    - Pod-śledczy:
      
      Sónia Pires, BSc
    - Pod-śledczy:
      
      Sónia Afonso, MSc
    - Kontakt:
      
      Miguel Castelo-Branco, MD, PhD
      
      Numer telefonu: +351 239488510
      
      E-mail: mcbranco@fmed.uc.pt
    - Pod-śledczy:
      
      Otília Cardoso de Almeida, PhD
- Porto District
  - Porto, Porto District, Portugalia, 4200-072
    - Rekrutacyjny
    - RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto
    - Główny śledczy:
      
      Catarina Mateus, PhD
    - Pod-śledczy:
      
      Nuno Rocha, PhD
    - Pod-śledczy:
      
      Rúben Magalhães, MSc
    - Pod-śledczy:
      
      Simão Ferreira, PhD
    - Pod-śledczy:
      
      Inês Pais, MSc
    - Pod-śledczy:
      
      Natália Almeida-Antunes, PhD
    - Pod-śledczy:
      
      Filipe Coelho, MSc
    - Pod-śledczy:
      
      Libânia Dias, BSc
    - Pod-śledczy:
      
      Cleuber Alves, BSc
    - Kontakt:
      
      Nuno B Rocha, PhD
      
      Numer telefonu: +351 913474780
      
      E-mail: nrocha@ess.ipp.pt

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

Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

Age between 18 and 40 years.
Diagnosis of anisometropic amblyopia, defined as unilateral amblyopia with an interocular difference of at least 2 lines in best-corrected visual acuity (BCVA), with BCVA worse than 20/32 in the more affected eye.

Exclusion Criteria:

Amblyopia other than anisometropic amblyopia.
Bilateral amblyopia.
Ophthalmologic or neuro-ophthalmologic disease other than amblyopia.
Neurological disease, chronic pharmacological therapy, or implanted medical devices.
Any ocular surgery or ocular treatment within the previous year.
Significant media opacities that may prevent fundus examination.
Inability to provide informed consent.

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: Potroić

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Eksperymentalny: Active Augmented Reality-Based Binocular Therapy Participants will receive active augmented reality-based binocular therapy for 10 weeks, with 40-minute sessions four times per week, initially in a clinical setting and subsequently at home.	Urządzenie: Active Augmented Reality-Based Binocular Therapy Active augmented reality-based binocular therapy will be delivered using a Meta Quest 3 mixed-reality headset operating in passthrough mode. Participants will complete 40-minute sessions four times per week for 10 weeks, initially learning to use the system in a clinical setting and subsequently continuing the training at home. The real-world scene presented to the amblyopic eye will remain close to natural viewing, while the contrast presented to the dominant eye will be selectively reduced. This controlled contrast reduction gives the amblyopic eye a relative visual advantage, encouraging its more active contribution during binocular viewing and promoting binocular integration. The degree of contrast modulation will be adjusted according to visual performance over the course of treatment.
Komparator placebo: Placebo Augmented Reality-Based Visual Training Participants will receive placebo augmented reality-based visual training for 10 weeks, with 40-minute sessions four times per week, using the same mixed-reality device and training schedule as the active group.	Urządzenie: Placebo Augmented Reality-Based Visual Training Placebo augmented reality-based visual training will be delivered using the same Meta Quest 3 mixed-reality headset operating in passthrough mode, with the same session duration, training schedule, and home-based setting as the active intervention. Participants will view and interact with their real-world surroundings while carrying out similar visual activities. Unlike the active intervention, the contrast presented to the dominant eye will not be selectively reduced. The visual information presented to both eyes will remain equivalent or will be only minimally and symmetrically modified, without providing active binocular rebalancing or a therapeutic visual advantage to the amblyopic eye.

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: Active Augmented Reality-Based Binocular Therapy

Participants will receive active augmented reality-based binocular therapy for 10 weeks, with 40-minute sessions four times per week, initially in a clinical setting and subsequently at home.

Urządzenie: Active Augmented Reality-Based Binocular Therapy

Active augmented reality-based binocular therapy will be delivered using a Meta Quest 3 mixed-reality headset operating in passthrough mode. Participants will complete 40-minute sessions four times per week for 10 weeks, initially learning to use the system in a clinical setting and subsequently continuing the training at home. The real-world scene presented to the amblyopic eye will remain close to natural viewing, while the contrast presented to the dominant eye will be selectively reduced. This controlled contrast reduction gives the amblyopic eye a relative visual advantage, encouraging its more active contribution during binocular viewing and promoting binocular integration. The degree of contrast modulation will be adjusted according to visual performance over the course of treatment.

Komparator placebo: Placebo Augmented Reality-Based Visual Training

Participants will receive placebo augmented reality-based visual training for 10 weeks, with 40-minute sessions four times per week, using the same mixed-reality device and training schedule as the active group.

Urządzenie: Placebo Augmented Reality-Based Visual Training

Placebo augmented reality-based visual training will be delivered using the same Meta Quest 3 mixed-reality headset operating in passthrough mode, with the same session duration, training schedule, and home-based setting as the active intervention. Participants will view and interact with their real-world surroundings while carrying out similar visual activities. Unlike the active intervention, the contrast presented to the dominant eye will not be selectively reduced. The visual information presented to both eyes will remain equivalent or will be only minimally and symmetrically modified, without providing active binocular rebalancing or a therapeutic visual advantage to the amblyopic eye.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at Week 10 Ramy czasowe: Baseline and Week 10	Best-corrected visual acuity of the amblyopic eye will be assessed monocularly using a standardized ETDRS chart and recorded as the number of letters correctly identified. Higher ETDRS letter scores indicate better visual acuity. Change from baseline will be calculated as the Week 10 letter score minus the baseline letter score. A positive change indicates an improvement in visual acuity.	Baseline and Week 10

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Change From Baseline in Near Stereoacuity at Week 10 Ramy czasowe: Baseline and Week 10	Near stereoacuity will be assessed binocularly using a graded circles stereotest with polarized glasses and recorded in seconds of arc. Measurable stereoacuity ranges from 400 to 20 seconds of arc. Lower values indicate better stereoacuity. Change from baseline will be calculated as the Week 10 value minus the baseline value. A negative change indicates an improvement. Participants unable to identify the largest disparity will be classified as having no measurable stereoacuity.	Baseline and Week 10
Change From Baseline in Interocular Suppression at Week 10 Ramy czasowe: Baseline and Week 10	Interocular suppression will be assessed under binocular viewing conditions using a standardized suppression test. The outcome will be the filter level at which binocular perception changes. Change from baseline will be calculated as the Week 10 value minus the baseline value.	Baseline and Week 10
Change From Baseline in Cortical Population Receptive Field Size at Week 10 Ramy czasowe: Baseline and Week 10	Cortical population receptive field (pRF) size will be assessed using functional magnetic resonance imaging (fMRI)-based retinotopic mapping. Mean pRF size will be estimated separately for the early visual areas V1, V2, and V3.	Baseline and Week 10
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Best-corrected visual acuity of the amblyopic eye will be assessed monocularly using a standardized ETDRS chart and recorded as the number of letters correctly identified. Higher ETDRS letter scores indicate better visual acuity. Change from baseline will be calculated as the 6-month follow-up letter score minus the baseline letter score. A positive change indicates an improvement in visual acuity.	Baseline and 6 months after treatment completion
Change From Baseline in Near Stereoacuity at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Near stereoacuity will be assessed binocularly using a graded circles stereotest with polarized glasses and recorded in seconds of arc. Measurable stereoacuity ranges from 400 to 20 seconds of arc. Lower values indicate better stereoacuity. Change from baseline will be calculated as the 6-month follow-up value minus the baseline value. A negative change indicates an improvement. Participants unable to identify the largest disparity will be classified as having no measurable stereoacuity.	Baseline and 6 months after treatment completion
Change From Baseline in Interocular Suppression at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Interocular suppression will be assessed under binocular viewing conditions using a standardized suppression test. The outcome will be the filter level at which binocular perception changes. Change from baseline will be calculated as the 6-month follow-up value minus the baseline value.	Baseline and 6 months after treatment completion
Change From Baseline in Static Achromatic Contrast Sensitivity in the Amblyopic Eye at Week 10 Ramy czasowe: Baseline and Week 10	Static achromatic contrast sensitivity will be assessed monocularly in the amblyopic and fellow eyes using the MonCV3 system (Metrovision). Sinusoidal gratings will be presented at a temporal frequency of 0 Hz and at spatial frequencies of 0.55, 1.1, 2.2, 3.4, 7.1, and 14.2 cycles per degree. Results will be recorded in decibels (dB) separately for each eye and spatial frequency, with higher values indicating better contrast sensitivity. Change from baseline will be calculated as the Week 10 value minus the baseline value. A positive change indicates improvement.	Baseline and Week 10
Change From Baseline in Static Achromatic Contrast Sensitivity in the Amblyopic Eye at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Static achromatic contrast sensitivity will be assessed monocularly in the amblyopic and fellow eyes using the MonCV3 system (Metrovision). Sinusoidal gratings will be presented at a temporal frequency of 0 Hz and at spatial frequencies of 0.55, 1.1, 2.2, 3.4, 7.1, and 14.2 cycles per degree. Results will be recorded in decibels (dB) separately for each eye and spatial frequency, with higher values indicating better contrast sensitivity. Change from baseline will be calculated as the 6-month follow-up value minus the baseline value. A positive change indicates improvement.	Baseline and 6 months after treatment completion
Change From Baseline in Retinal Neuronal Layer Thicknesses at Week 10 Ramy czasowe: Baseline and Week 10	Retinal structure will be assessed in the amblyopic and fellow eyes using the CIRRUS HD-OCT 5000 (ZEISS). The outcome measures will include total macular thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and peripapillary retinal nerve fiber layer (RNFL) thickness. Measurements will be recorded in micrometers (µm) and analyzed separately for each eye and prespecified retinal sector. Change from baseline will be calculated as the Week 10 value minus the baseline value for each thickness parameter.	Baseline and Week 10
Change From Baseline in Retinal Neuronal Layer Thicknesses at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Retinal structure will be assessed in the amblyopic and fellow eyes using the CIRRUS HD-OCT 5000 (ZEISS). The outcome measures will include total macular thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and peripapillary retinal nerve fiber layer (RNFL) thickness. Measurements will be recorded in micrometers (µm) and analyzed separately for each eye and prespecified retinal sector. Change from baseline will be calculated as the 6-month follow-up value minus the baseline value for each thickness parameter.	Baseline and 6 months after treatment completion
Change From Baseline in Retinal Ganglion Cell Function Assessed by Pattern Electroretinography at Week 10 Ramy czasowe: Baseline and Week 10	Retinal ganglion cell function will be assessed in the amblyopic and fellow eyes using pattern electroretinography (PERG) recorded with the Tomey EP-1000 Pro system. N95 amplitude, measured in microvolts (µV), and N95 implicit time, measured in milliseconds (ms), will be extracted and analyzed separately for each eye. Change from baseline will be calculated as the Week 10 value minus the baseline value for each PERG parameter.	Baseline and Week 10
Change From Baseline in Retinal Ganglion Cell Function Assessed by Pattern Electroretinography at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Retinal ganglion cell function will be assessed in the amblyopic and fellow eyes using pattern electroretinography (PERG) recorded with the Tomey EP-1000 Pro system. N95 amplitude, measured in microvolts (µV), and N95 implicit time, measured in milliseconds (ms), will be extracted and analyzed separately for each eye. Change from baseline will be calculated as the 6-month follow-up value minus the baseline value for each PERG parameter.	Baseline and 6 months after treatment completion
Change From Baseline in Cortical Population Receptive Field Size at 6-Month Follow-up Ramy czasowe: Baseline and 6 months after treatment completion	Cortical population receptive field (pRF) size will be assessed using functional magnetic resonance imaging (fMRI)-based retinotopic mapping. Mean pRF size will be estimated separately for the early visual areas V1, V2, and V3.	Baseline and 6 months after treatment completion

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Polytechnic Institute of Porto

Współpracownicy

University of Coimbra

OPTIMIZER - Serviços e Consultadoria Informática, Lda.

LINOVT - Engenharia Software, Lda.

Publikacje i pomocne linki

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

Publikacje ogólne

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)

1 maja 2026

Zakończenie podstawowe (Szacowany)

31 stycznia 2028

Ukończenie studiów (Szacowany)

31 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

8 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 września 2026

Pierwszy wysłany (Rzeczywisty)

15 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

ORT-2026-003
COMPETE2030-FEDER-01469700 (Inny numer grantu/finansowania: Portugal 2030 - COMPETE 2030)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared because the approved data protection plan limits the use of coded study data to this project and does not permit their transfer to other institutions, investigators, or countries. Study findings may be disseminated only in aggregated, non-identifiable form.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

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 .

Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia (Ambly4Home)

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Szacowany)

Faza

Kontakty i lokalizacje

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Współpracownicy

Publikacje i pomocne linki

Publikacje ogólne

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Szacowany)

Ukończenie studiów (Szacowany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Rzeczywisty)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Opis planu IPD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA