CTRI/2023/05/052558进行中（未招募）Unknown
Contact lenses utilising S.T.O.P.® technology versus dual-focus contact lenses for slowing down myopia progression in children: A three-year prospective, multi-centre, controlled, masked, randomised, non-inferiority clinical trial
Brighten Optix0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Be between 8 to 14 years
- •1.Have read the Informed Assent
- •2.Been explained the Informed Assent
- •3.Indicated an understanding of the Informed Assent
- •4.Signed the Informed Assent
- •5.Have their parent or legal guardian
- •6. read the Informed Consent
- •7. been explained the Informed Consent
- •8.indicated an understanding of the Informed Consent
- •9.signed the Informed Consent
- •10. Along with their parent or legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements
- •11. Along with their parent or legal guardian, agree to maintain the visit schedule
- •12.Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not more than 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons
- •13.Possess wearable and visually functioning spectacles
- •14.Be in good general health, based on the parent or legal guardian knowledge
- •15.Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR or better in each eye.
- •16. Meet the following criteria determined by cycloplegic autorefraction
- •17.spherical equivalent between -0.75 to -4.00 D inclusive
- •18. astigmatism less than or equal to -1.00 D (participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if less than or equal to -0.75 D is measured with subjective refraction)
- •19.anisometropia less than or equal to 1.00 D
排除标准
- •Participant is currently, or within 30 days prior to this study, has been anactive participant in another myopia control study
- •1. Current or prior use of ANY form of myopia control, including but notlimited to:
- •2. Optical devices
- •3. bifocal / multifocal spectacles of any type
- •4. bifocal / multifocal contact lenses of any type
- •5.orthokeratology of any type
- •6. Pharmacological agents
- •7. atropine
- •8. pirenzepine
- •9.Participant born earlier than 30 weeks or weighed < 1500 g at birth
- •10. Habitual use of a systemic or topical medication that may alter normalocular findings / is known to affect a participant’s ocular health / physiologyor contact lens performance either in an adverse or beneficial manner atenrolment and / or during the clinical trial.
- •11.A known allergy to sodium fluorescein, benoxinate, proparacaine, ortropicamide
- •12.A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,corneal infiltrates, ocular viral or fungal infections, or any other recurrentocular infections
- •13. Strabismus by cover test at distance (3 m) or near (40 cm) while wearingdistance correction under non-cycloplegic conditions
- •14.Known ocular or systemic disease, such as but not limited to:
- •15. Diabetes
- •16.Graves’ disease
- •17. glaucoma
- •18.uveitis
- •19.scleritis
- •20.auto immune diseases such as ankylosing spondylitis, multiplesclerosis, Sjogrens syndrome, and systemic lupus erythematosus
- •21. Any ocular, systemic, or neuro-developmental conditions that couldinfluence refractive development, such as but not limited to:
- •22.persistent pupillary membrane
- •23.vitreous haemorrhage
- •24.cataract
- •25. central corneal scarring
- •26.eyelid haemangiomas
- •27. Marfan’s syndrome
- •28.Down’s syndrome
- •29.Ehler’s-Danlos syndrome
- •30. Stickler’s syndrome
- •31.ocular albinism
- •32.retinopathy of prematurity
- •33. Keratoconus or irregular cornea
- •34. Biomicroscopic that contraindicate contact lens, such as but limited to:
- •35.neovascularisation or ghost vessels = 1.5 mm in from limbus
- •36. any active anterior segment disease that contraindicates safe contact lens wear
- •37. clinically significant giant papillary conjunctivitis
- •38.clinically significant abnormalities of the anterior segment, lids,conjunctiva, sclera, or associated structures
- •39.allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule
- •40.The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests
研究者
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