The Safety and Effectiveness of Breath-O Lenses

The Hong Kong Polytechnic University

Status: Completed

Conditions: Myopia; Safety Issues

Treatments: Other: Breath-O-Correct Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT03616600

HongKongPU_Optometry2

Details and patient eligibility

About

In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

Full description

Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

Enrollment: 31 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)
2. Best corrected Visual acuity: monocular ETDRS 0.0 or better
3. Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
4. General health: No systemic diseases
5. Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Treatment

Experimental group

Description:

Wearing the orthokeratology lenses for 3 months

Treatment:

Other: Breath-O-Correct Lens

Control

No Intervention group

Description:

Not wearing any contact lenses