Control of Myopia Progression with STOP technology
- Registration Number
- CTRI/2023/05/052558
- Lead Sponsor
- Brighten Optix
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Axial Length <br/ ><br>(Difference in change from baseline in axial length between test and control contact lenses)Timepoint: Baseline, 1 month, 6 months, 12 months, 18 months , 24 months, 30 months, 36 months
- Secondary Outcome Measures
Name Time Method