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临床试验/CTRI/2019/09/021193
CTRI/2019/09/021193尚未招募不适用

COMPARATIVE STUDY OF MYOPIA PROGRESSION IN SUBJECTS ON LOW DOSAGE OFATROPINE WITH MATCHED CONTROLS OF DIFFERENT AGE GROUPS

Centre for Sight1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年12月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
1.Change in spherical equivalent refractive error (SER) relative to baseline (Indicator of progression of myopia)

研究概览

简要总结

Control of myopia progression has become an important goal, as myopia is a leading cause of visual disability throughout the world. In India uncorrected refractive errors are one of the most common causes of visual impairment. Currently, on average, 30% of the world is myopic and by 2050, based on current trends, almost 50% will be myopic, that’s 5 billion people.High Myopia may be associated with significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. Several methods including use of progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications (increased outdoor activity) have reported to alter myopia progression with varying efficacy. In general they have yielded clinical results of marginal significance. Atropine sulphate eye drops (1%) has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Yet, it has not found widespread clinical application for myopia control due to ocular side-effects of cycloplegia and pupil dilation. Recently, 0.01% atropine has been shown to be effective in arresting myopia progression without side-effects of cycloplegia and near vision impairment and pupil dilation and increased light sensitivity. However, almost all studies on atropine have been carried out on children of Chinese origin (SE Asia). Efficacy (concentration and dosing)and safety need to be established in the population of interest, before routine use can be recommended. We plan to evaluate the efficacy and safety of topical atropine eye drops(0.01%) in slowing the progression of myopia and ocular axial elongation in Indian children. A total of 80 children of ages 6-18 years will be classified into two groups based on age, which will further be randomized into two sub groups. Intervention subgroup for each age group will receive atropine 0.01% once daily in each eye. Control group will not receive any medications. Follow up visits will be scheduled every six months The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods. It will alsobe compared on different grades of myopia and different age groups to state the best time to start myopia control.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
6.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Age: 6 to 18 years
  • Myopia ≥ 2.00 D (cycloplegic refraction; spherical equivalent) with or without any astigmatism
  • The minimum increase in refractive error should be 0.75DS in less than 6 months.
  • Provide written informed consent;
  • No prior or current treatment for preventing myopia progression (bifocals / progressive addition lenses / orthokeratology)
  • Willingness and ability to follow all instructions and comply with schedule for follow-up visits.

排除标准

  • Best corrected visual acuity < 6/18
  • Simple myopic/hyperopic astigmatism with 0 spherical refractive error (Pure astigmatism)
  • No prior or current treatment for preventing myopia progression (bifocals / progressive addition lenses / orthokeratology)
  • Ocular diseases like Retinal dystrophy, Retinopathy of prematurity, Corneal opacities, keratoconus, Ocular hypertension / Glaucoma
  • Prior intraocular surgery
  • Allergy to atropine eye drops
  • Lack of consent for participating in the study
  • Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome, Down syndrome, cardiac or significant respiratory diseases
  • Those lost to follow-ups, lack of 80% compliance to Atropine 0.01% eyedrops
  • In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.

结局指标

主要结局

1.Change in spherical equivalent refractive error (SER) relative to baseline (Indicator of progression of myopia)

时间窗: 2years

2. Change in axial length during follow-up relative to baseline (Increased axial length correlates with myopic progression).

时间窗: 2years

次要结局

  • Any adverse events (blurred near vision, glare, allergic reaction, if any)(2 years)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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