Clinical trial NCT05733884: Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial
Official title: Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Contact Lens
Keywords: axial length
children
myopia control
soft contact lens
clinical trials
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
* Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
* The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.

  1. 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).
  2. No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
  3. 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.
  4. No iritis.
  5. There are no other active eye diseases that are not suitable for contact lens wear.
* No topical eye drops are currently being used.
* The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
* Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
* Meet the following refractive criteria determined by cycloplegic autorefraction at baseline

  1. Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
  2. Astigmatism: ≤-0.75 D
  3. Anisometropia: \<1.00 D

Exclusion criteria:

* Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
* Those who are unable to comply with regular tracking and inspection.
* Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
* Subject has undergone any eye surgery or corneal surgery.
* 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.
* Those who are unable to cooperate with regular tracking and inspection.
* Participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.

Primary outcomes:
measure: Spherical Equivalent Refraction (SER)
timeFrame: 12 months
Secondary outcomes:
measure: Axial Eye Length (AXL)
timeFrame: 12 months
Other outcomes:
measure: Primary safety Endpoints
timeFrame: 12 months
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Min yen Hsu, PhD
role: STUDY_DIRECTOR
References: