The Different Design of Orthokeratology

Sponsor

Tianjin Eye Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05956704

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Orthokeratology with aspheric wide inversion zone design in the optical zone Device: Orthokeratology with traditional spherical design in the optical zone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Jun 1, 2023

Actual Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group	Device: Orthokeratology with aspheric wide inversion zone design in the optical zone An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone
Active Comparator: Control group	Device: Orthokeratology with traditional spherical design in the optical zone Subjects wore the orthokeratology with traditional spherical design in the optical zone
No Intervention: Blank control group

Arm

Intervention/Treatment

Experimental: Experimental Group

Device: Orthokeratology with aspheric wide inversion zone design in the optical zone

An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone

Active Comparator: Control group

Device: Orthokeratology with traditional spherical design in the optical zone

Subjects wore the orthokeratology with traditional spherical design in the optical zone

No Intervention: Blank control group

Outcome Measures

Primary Outcome Measures

Changes in axial length [The change of baseline and 1years]
Axial length was measured with a biometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The age is greater than 8 years and less than 18 years
The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
Be able to complete 12 months of follow-up
They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians

Exclusion Criteria:

One eye met the inclusion criteria
Patients with systemic diseases causing immunocompromised or affecting orthokeratology
There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
Abnormal cornea
Previous corneal surgery or corneal trauma history
Active keratitis (e.g., corneal infection)
Patients with best corrected distance visual acuity of less than 5.0
Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
Patients with refractive instability
Patients with overt strabismus
The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
Patients with dry eye are not suitable for orthokeratology
Patients with corneal endothelial cell density less than 2000 cells /mm2
Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Eye Hospital	Tianjin		China	300020

Sponsors and Collaborators

Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Eye Hospital

ClinicalTrials.gov Identifier:

NCT05956704

Other Study ID Numbers:

KY2023031

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Jul 21, 2023