Efficacy of 3D Versus 2D Movie Viewing on Stereopsis and Visual Function in Children With Residual Ambliopia. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change from baseline in stereoacuity measured with the Random Dot 2 Stereo Test (log arcsec)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change from baseline in stereoacuity measured with the Random Dot 2 Stereo Test (log arcsec)
时间窗: 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)
Stereoacuity will be assessed using the validated Random Dot 2 Stereo Test. Results will be recorded in arcseconds and analyzed as log arcsec. The primary endpoint is the change from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Change from baseline in best-corrected visual acuity (BCVA) of the amblyopic eye measured with ETDRS (logMAR)
时间窗: 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).
Best-corrected visual acuity of the amblyopic eye will be assessed using standardized ETDRS optotypes with the participant wearing habitual optical correction. Visual acuity will be recorded in logMAR. The outcome is the change in BCVA from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Change from baseline in ocular deviation measured by cover test with prism bars at distance (6 m) and near (40 cm) (prism diopters)
时间窗: 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)
Ocular deviation will be assessed using the cover test with prism bars at distance (6 m) and near (40 cm). The magnitude and direction of deviation will be recorded in prism diopters (PD/DP), distinguishing esotropia and exotropia when present. The outcome is the change in ocular deviation from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
次要结局
- Change from baseline in binocular sensory status (suppression/fusion) measured by the Worth 4 Dot test at distance and near.(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(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(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(Post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).)
研究者
Laura Asensio Jurado
Principal Investigator
Universitat Politècnica de Catalunya