Myopia control efficacy of Spectacle lenses with Highly aspherical lenslets (HAL) in high myopia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in axial length
研究概览
简要总结
This prospective controlled clinical trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad, and the study protocol will adhere to the tenets of Declaration of Helsinki. Participants will be recruited based on the inclusion and exclusion criteria either from The Infor Myopic Clinic, L V Prasad Eye Institute, Hyderabad or by advertisement in local media (newspaper), or approaching schools for referrals. An informed consent will be obtained from each participant (parent/guardian of participating child) after explaining the nature of the study. Assent will be obtained from the participating children. Detailed ocular and medical history will be elicited followed by comprehensive examination (visual acuity, slit lamp examination, open-field autorefraction, subjective refraction), pupillometry, specialty tests such as binocular vision assessments, axial length measurement, peripheral refraction, optical coherence tomography, corneal topography. All participants will undergo cycloplegic refraction after instillation of Tropicamide 1% eye drops. Measurements will be obtained thirty minutes after instillation of eye drops. Eligible participants will be called for the dispensing visit and then following study visits at 3 month, 6 months and 12 months. In each follow-up visits, the required ocular parameters such as visual acuity, slit lamp examination, axial length, peripheral refraction, open field autorefraction, subjective refraction, pupillometry, optical coherence tomography, corneal topography along with participant’s compliance to the spectacles provided will be assessed to analyze the efficacy of these spectacles in controlling myopia progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age between 6 to 14 years inclusive at time of enrolment 2.Interested in wearing spectacles for 5 days per week and 6 hours in a day 3.Best-corrected high contrast visual acuity based on manifest refraction of 0.18 logMAR 4.spherical equivalent-6.00 D to -11
- •astigmatic component 0 DC to -3.0DC 6.Spherical equivalent anisometropia less than or equal to 2.50 D.
排除标准
- •1.Current or prior use of ANY form of myopia control strategy 2.Participant born earlier than 30 weeks or weighed less than 1500 gm at birth 3.Any ocular, systemic, or neuro-developmental conditions that may influence refractive error 4.Manifest strabismus (tropia) 5.Any known ocular inflammation or infection.
结局指标
主要结局
Change in axial length
时间窗: 3 Months, 6 months and 12 months
次要结局
- change in spherical equivalent refractive error(Base line, 3,6, 12 months)
研究者
DrPavan Verkicharla
L V Prasad Eye Institute
