The Safety and Effectiveness of Breath-O Lenses

NCT03616600 | Completed Results

• 1 other identifier: HongKongPU_Optometry2
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Safety Issues

Keywords

Myopia; Orthokeratology

Outcome Measures

Primary Outcomes (5)

• Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor

  measured by ocular response analyser

  Baseline, 1st Month, 3rd Month

• Corneal Endothelial Health in Terms of Endothelial Cell Density

  measured by specular microscope

  Baseline, 1st Month, 3rd Month

• Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size

  measured by specular microscope

  Baseline, 1st Month, 3rd Month

• Anterior Ocular Health in Terms of Limbal and Bulbar Redness

  measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests

  Baseline, 1st Month, 3rd Month

• Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)

  measured by OCULUS Keratograph® 5M

  Baseline, 1st Month, 3rd Month

Secondary Outcomes (2)

• Best Corrected Visual Acuity in Terms of High and Low Contrast

  Baseline, 1st Month and the 3rd Month

• Reduction of the Refractive Power After Wearing the Breath-O-correct Lens

  Baseline, 1st Week, 1st Month, 3rd Month

Study Arms (2)

Treatment

EXPERIMENTAL

Wearing the orthokeratology lenses for 3 months

Other: Breath-O-Correct Lens

Control

NO INTERVENTION

Not wearing any contact lenses

Interventions

Breath-O-Correct Lens OTHER

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

Treatment

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Best corrected Visual acuity: monocular ETDRS 0.0 or better
• Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
• General health: No systemic diseases
• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• SEED Co. Ltd.: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. Henry Chan
• Organization: Hong Kong Polytechnic University

henryhl.chan@polyu.edu.hk

+85227667937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocaite Professor

Model Details: Randomized control trial

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: August 6, 2018
• Study Start: March 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: January 15, 2019
• Last Updated: February 10, 2021
• Results First Posted: April 13, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)