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The Different Design of Orthokeratology

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Orthokeratology with aspheric wide inversion zone design in the optical zone
Orthokeratology with traditional spherical design in the optical zone
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tianjin Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental Group

Control group

Blank control group

Arm Description

Outcomes

Primary Outcome Measures

Changes in axial length
Axial length was measured with a biometer

Secondary Outcome Measures

Full Information

First Posted
July 14, 2023
Last Updated
July 14, 2023
Sponsor
Tianjin Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05956704
Brief Title
The Different Design of Orthokeratology
Official Title
The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Blank control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Orthokeratology with aspheric wide inversion zone design in the optical zone
Intervention Description
An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone
Intervention Type
Device
Intervention Name(s)
Orthokeratology with traditional spherical design in the optical zone
Intervention Description
Subjects wore the orthokeratology with traditional spherical design in the optical zone
Primary Outcome Measure Information:
Title
Changes in axial length
Description
Axial length was measured with a biometer
Time Frame
The change of baseline and 1years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Different Design of Orthokeratology

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