A single-centre, prospective, randomized, single-masked, controlled clinical trial to evaluate the DIMSHYP spectacle lenses visual performance and reduction of hyperopia in children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effect of the DIMSHYP spectacle lens on visual performance and in refractive correction in non-diseased, non-amblyopic hyperopic children over a period of up to 24 months.
研究概览
简要总结
India has a high burden of refractive errors (REs), including hyperopia, among school-going children. The overall prevalence of RE per 100 children is 8.0 and in schools it is 10.8. The population-based prevalence of hyperopia is 4.0%. Uncorrected and under corrected REs can affect a child’s academic performance, social participation, and future economic productivity. RE correction improves educational outcomes but has not distinguished the type of RE. Hyperopic correction improves accommodative performance for sustained reading tasks for the majority of participants. RE correction with Defocus Incorporated Multiple Segments (DIMS) spectacle lenses produces significant improvement in Visual Acuity (VA). DIMS spectacle lenses have good tolerance and acceptability. Moreover, DIMS spectacle lenses produce significantly better outcomes than single vision (SV) spectacle lenses and result in sustained long-term improvement. However, these findings are restricted to children with myopia, and effect of DIMS spectacle lenses in school going children with hyperopia remains to be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects’ age at time of parent (or guardian) consent and subject assent: 6 -9 years old.
- •Subjects with cycloplegic autorefraction SER between +2.00 D and +6.50 D.
- •Subjects with cycloplegic autorefraction astigmatism of 1.50 D or less.
- •Subjects with cycloplegic autorefraction anisometropia of 1.50 D or less.
- •Subjects with monocular best-corrected distance visual acuity (BCDVA) under cycloplegic equal to or better than logMAR 0.08 (better than 20/25).
- •Subjects in which baseline 3D macula optical coherence tomography (OCT) volume scan can clearly measure sub-foveal choroidal thickness.
- •Subjects and parents (or LAR) are able and willing to provide oral/verbal assent and consent, respectively.
- •Subjects and parents (or LAR) assure to attend required study visits and adhere to participant requirements.
- •The parent (or LAR) understands and accepts random allocation of grouping, and the subject and parent (or LAR) will not know the allocated group.
- •Subjects are willing to wear the study spectacle lens for a minimum of 12 hours per day for the duration of the study.
排除标准
- •Subjects with an allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops.
- •Subjects with any ocular and systemic abnormalities that might be expected to affect visual functions or refractive development.
- •Subjects with prior treatment of hyperopic control six months prior to the screening.
- •Subjects with clinically significant strabismus orbinocular vision abnormalities
- •Subjects with amblyopia or history of amblyopia.
- •Subjects with previous intraocular surgery.
- •Subjects with participation in a clinical trial within 30 days before the study entry into this study.
- •Subjects with presence of any emotional, physiologic or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment, based on the clinical judgment of the investigator.
- •Subjects with any medical treatment or medication which might influence the vision or interfere with study assessments.
结局指标
主要结局
To evaluate the effect of the DIMSHYP spectacle lens on visual performance and in refractive correction in non-diseased, non-amblyopic hyperopic children over a period of up to 24 months.
时间窗: Baseline and 24 months
次要结局
- To evaluate the reduction of hyperopia with DIMSHYP spectacle lens in non-diseased, non-amblyopic hyperopic children over a period of up to 24 months.(Baseline and 24 months)
研究者
Dr Triveni Venkat
Dr Agarwals Eye Hospital