Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial
Study Details
Study Description
Brief Summary
A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. |
Other: soft contact lens
soft contact lens
|
| Active Comparator: Omafilcon A, dual-focus optical design, USA Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. |
Other: soft contact lens
soft contact lens
|
Outcome Measures
Primary Outcome Measures
- Spherical Equivalent Refraction (SER) [12 months]
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
Secondary Outcome Measures
- Axial Eye Length (AXL) [12 months]
The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.
Other Outcome Measures
- Primary safety Endpoints [12 months]
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates will be measured.(700GL Slit Lamp, Takagi Europe)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
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Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
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The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.
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Based on the slit-lamp examination results of the screening clinic, determined that the infection of the conjunctiva, eyelids and accessory organs was less than Grade 2 (mild).
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No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
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Slit lamp findings must be less than Grade 1 (mild) and the cornea must not show: edema, staining, clouding, or vascularization according to the slit lamp findings of the screening clinic.
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No iritis.
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There are no other active eye diseases that are not suitable for contact lens wear.
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No topical eye drops are currently being used.
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The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
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Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
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Meet the following refractive criteria determined by cycloplegic autorefraction at baseline
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Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
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Astigmatism: ≤-0.75 D
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Anisometropia: <1.00 D
Exclusion criteria:
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Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
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Those who are unable to comply with regular tracking and inspection.
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Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
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Subject has undergone any eye surgery or corneal surgery.
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Subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry.
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Those who are unable to cooperate with regular tracking and inspection.
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Participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chung Shan Medical University Hospital | Taichung | Taiwan | 402 |
Sponsors and Collaborators
- Chung Shan Medical University
Investigators
- Study Director: Min yen Hsu, PhD, Chung Shan Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS1-20136