VISION-3D: Visual Skills Improvement With On-screen 3D Movies.

Официальное название

Efficacy of 3D Versus 2D Movie Viewing on Stereopsis and Visual Function in Children With Residual Ambliopia. A Randomized Controlled Trial.

Обзор

This clinical study investigates whether watching 3D films can help improve the vision of children with residual amblyopia (lazy eye), that is, those children who, despite having undergone usual treatments such as glasses or patching, still maintain some visual deficit. The main objective is to verify whether viewing in 3D is better than viewing in 2D in improving depth vision (stereopsis), visual acuity and ocular alignment. The hypothesis is that 3D films, by providing richer binocular stimuli, will produce greater improvements than the same 2D films. Children between 4 and 14 years of age with residual, stable and previously treated unilateral amblyopia will be included. Participants will be recruited from the pediatric ophthalmology/optometry clinics of the Mútua University Hospital The study will be conducted in two locations: the visual examinations will be performed at the Mútua University Hospital in Terrassa, and the film sessions at the Faculty of Optics and Optometry of Terrassa (FOOT, UPC), in rooms prepared with a projector and 3D glasses. The design is randomized and controlled. In a first phase, the children will be randomly divided into two groups: one group will watch 3 films in 3D and the other will watch the same films in 2D. Then, in a second phase, all participants will watch 3 additional sessions in 3D. Four evaluation visits will be made: before starting, after phase 1, after phase 2 and a follow-up two months later. These visits will measure stereopsis, visual acuity, and ocular deviation with standard optometric tests. Watching 3D movies is a safe and non-invasive activity; therefore, no significant risks are expected beyond some possible mild and transient discomfort such as eye strain or headache, which will be recorded if it occurs. Potential benefits include improved depth perception and other visual functions, and the results could open the door to new, fun and motivating therapeutic options for other children with amblyopia in the future.

Вмешательства

• Поведенческое Stereoscopic (3D) Movie Viewing
  Repeated binocular visual stimulation. Participants view age-appropriate commercial films under standardized conditions once a week for three consecutive weeks in Phase 1. In the experimental intervention, the films are viewed in stereoscopic 3D using active shutter glasses and a calibrated 3D projection system. Each session lasts 90-120 minutes. After Phase 1, all participants receive three additional weekly 3D sessions (delayed treatment extension).
• Поведенческое 2D Movie Viewing
  Repeated binocular visual stimulation. Participants view age-appropriate commercial films under standardized conditions once a week for three consecutive weeks in Phase 1. In the control intervention, the films are viewed in 2D with identical duration and setting. Each session lasts 90-120 minutes. After Phase 1, all participants receive three additional weekly 3D sessions (delayed treatment extension).

Первичные конечные точки

• Change from baseline in stereoacuity measured with the Random Dot 2 Stereo Test (log arcsec) [Срок оценки: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)]
• Change from baseline in best-corrected visual acuity (BCVA) of the amblyopic eye measured with ETDRS (logMAR) [Срок оценки: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2).]
• Change from baseline in ocular deviation measured by cover test with prism bars at distance (6 m) and near (40 cm) (prism diopters) [Срок оценки: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)]

Вторичные конечные точки (4)

• Change from baseline in binocular sensory status (suppression/fusion) measured by the Worth 4 Dot test at distance and near. [Срок оценки: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2).]
• Retinal correspondence status assessed by the Bagolini striated lens test [Срок оценки: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)]
• Vision-related quality of life measured by the Pediatric Eye Questionnaire (PedEyeQ) total score [Срок оценки: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).]
• Participant/family satisfaction with the intervention measured by a study-specific Likert satisfaction questionnaire [Срок оценки: Post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).]

Критерии участия

Критерии включения

• Children aged 4 to 12 years.
• Previous diagnosis of unilateral amblyopia (anisometropic, strabismic, or mixed).
• History of conventional treatment (optical correction, occlusion and/or penalization) with stable visual acuity for at least 6 months.
• Interocular visual acuity difference ≥ 0.2 logMAR (≈ ≥2 Snellen lines).
• Ability to understand and follow age-appropriate basic instructions.
• Parent/guardian consent (and child assent when applicable)

Критерии исключения

• Ocular surgery within the last 6 months.
• Manifest strabismus >15 prism diopters.
• Concomitant ocular pathology that may affect vision (e.g., cataract, nystagmus, ptosis, corneal opacity, retinal disease, optic neuropathy).
• Cognitive or neurological deficits preventing compliance with the protocol.
• Prior intensive exposure to 3D cinema or VR/3D videogames that could act as a confounder.
• Family or child refusal to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Asensio-Jurado L, Argiles M, Quevedo-Junyent L, Mestre C, Levi DM. Can viewing a 3D movie improve visual function in children with a history of amblyopia and neurotypical children?: A pilot study. PLoS One. 2024 Jun 25;19(6):e0305401. doi: 10.1371/journal.pone.0305401. eCollection 2024. PMID 38917142

Идентификаторы

NCT: NCT07301645 · PDE1LAJ.VISION3D

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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