Influence of Corneal Biomechanical Properties on Myopia Control

NCT ID: NCT05090592

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control

Detailed Description

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High myopia is accompanied by excessive growth of eyeball, which leads to many complications. Myopia control is a great concern of the government and ophthalmologists worldwide.

Atropine eye drops is used clinically to control the progression of myopia. In recent years, low dose Atropine eye drops (0.01%, 0.05% and 0.1%) have been proven to be effective in slowing growth of eyeball. With less negative effects, these eye drops have been widely used for school children in Taiwan. Orthokeratology is another effective tool to control myopia, and long-term wearing of Ortho-k lens can inhibit the speed of eyeball growth, it is the most useful optical treatment for myopia control.

The Corvis® ST is a combination of an air pulse tonometer with an ultra-high-speed Scheimpflug camera. The movement of the cornea is mainly influenced by three factors which can be measured by the instrument:

Intraocular pressure (IOP),biomechanical properties of the cornea and corneal thickness. The relationship between adult corneal biomechanics and refractive error has been noted in recent years. Previous studies pointed out that corneal biomechanics analyzer (Corvis ST) can measure the deformation process of the cornea and the biomechanics parameters. These literature found that the corneas of myopic patients, esp. high myopic, have larger corneal deformation in biomechanics analysis and revealed that the corneal stiffness of myopia patients was lower. There are still few discussions about the effect of orthokeratology on corneal biomechanics and there is no research focused on the change of corneal biomechanics of low-concentration atropine user which is worthy of our further exploration.

In this study, the investigators hope to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control.

Conditions

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Myopia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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myopic children

Myopic children use overnight orthokeratology or 0.01% atropine eye drop per night for myopia control

orthokeratology

Intervention Type DEVICE

orthokeratology wearing for myopia control

0.01 atropine

Intervention Type DRUG

0.01% atropine eye drop prevent myopic progression

Interventions

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orthokeratology

orthokeratology wearing for myopia control

Intervention Type DEVICE

0.01 atropine

0.01% atropine eye drop prevent myopic progression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* myopia (\<-1D)
* received Orthokeratology or 0.01% atropine for myopia control
* regular follow-up

Exclusion Criteria

* ocular surface disease( dry eye, keratoconus..)
* allergy to orthokeratology or atropine
* received eye surgery

* strabismus
* premature birth
Minimum Eligible Age

8 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng-Jen Chiu, Doctor

Role: STUDY_DIRECTOR

Tzu Chi genral hospital

Locations

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Yu-Teng Lai

Yilan, Ilan County, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Buddhist TCGH

Identifier Type: -

Identifier Source: org_study_id