Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial

Not Applicable

Completed

• Conditions: Soft Contact Lens
• Interventions: Other: soft contact lens

• Registration Number: NCT05733884
• Lead Sponsor: Chung Shan Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-09
• Primary Completion: 2022-05-04
• Study Completion: 2022-05-04
• Study First Submitted: 2023-01-16
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan	soft contact lens	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.
Omafilcon A, dual-focus optical design, USA	soft contact lens	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.

Primary Outcome Measures

Name	Time	Method
Spherical Equivalent Refraction (SER)	12 months	The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan