Randomised Controlled Trial of Hoya SYNC III Design Lenses

The Institute of Optometry, London4 个研究点分布在 2 个国家目标入组 90 人开始时间: 2019年1月7日最近更新: 2020年7月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 90
试验地点: 4
主要终点: Change in CVS-Q

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Many people using computers or digital devices (e.g., smartphones or tablets) experience eyestrain and this has been called Computer Vision Syndrome (CVS) or Digital Eye Strain. Spectacle lens manufacturers have designed products to alleviate the symptoms of CVS. One such product, designed by Hoya (SYNC III), aims to do this by providing accommodative support. The present study is a parallel group double-masked RCT of people with CVS. One group will receive Hoya SYNC III lenses and the other (control) group single vision (SV) lenses. The main aims are to evaluate whether:

binocular vision and accommodative functions at baseline can predict participants who benefit from SYNC III design lenses;
the wearing of SYNC III design lenses is associated with any changes in binocular and accommodative functions at 6 months of follow-up;
the wearing of lenses with accommodative support reduce the symptoms of computer vision syndrome at 3 and 6 months of follow-up.

Participants will be examined three times: at baseline and three and six months after receiving their lenses. The group who receive control lenses will be provided with SYNC III lenses at the end of the six month trial for a brief one week follow-up evaluation.

详细描述

Background Aims

The aims of the research are to use a parallel group randomised controlled trial to:

Evaluate whether binocular vision and accommodative functions at baseline can predict any participants who benefit from SYNC III design lenses;
Evaluate whether the wearing of SYNC III design lenses is associated with any changes in binocular and accommodative functions at 6 months of follow-up;
Evaluate whether the wearing of lenses with accommodative support may reduce the symptoms of computer vision syndrome at 3 and 6 months of follow-up.

Methods Design The research is a double-masked randomised controlled trial. Participants will be randomly allocated to two groups, one of whom wears SYNC III design lenses and the other who will wear SV control lenses.

The research involves thirty participants (15 wearing SYNC III design and 15 with SV) who will be seen at the Institute of Optometry, London; and 60 participants (30 wearing SYNC III design and 30 with SV) seen at the University of Alicante.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Aged between 18 and 40 years;
•In a typical working day, spends at least 2 hours viewing digital devices (e.g., desktop, laptop, tablet, smart phone);
•Symptoms associated with the use of digital devices, quantified as a score of six points or more on the CVS-Q questionnaire instrument;1
•Use of spectacles, at least 6, months previous to the beginning of the study;
•Refractive error between +6.00 to -8.00 with cyl up to 4.00DC.

排除标准

•Previous use of accommodative support lenses
•Ocular pathology requiring referral to an ophthalmologist
•Wears contact lenses when using computers