Influence of Corneal Biomechanical Properties on Myopia Control

NCT05090592 | Unknown DMC FDA Drug FDA Device

• 1 other identifier: Buddhist TCGH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Myopia

Outcome Measures

Primary Outcomes (5)

• changes of the intraocular pressure in myopic children with different treatment

  the investigators measure the intraocular pressure(IOP, mmHg) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology)

  from the date of starting treatment, the IOP was measured 1 week, 1month and every 3 months up to 24 months.

• changes of the visual acuity in myopic children with different treatment

  the investigators measure the visual acuity of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).

  from the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.

• changes of the central corneal thickness in myopic children with different treatment

  the the investigators measure the central corneal thickness(CCT, micrometer, ㎛) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine

  from the date of starting treatment, the central corneal thickness was measured 1 week, 1month and every 3 months up to 24 months.

• changes of the corneal biomechanics index in myopic children with different treatment

  the the investigators measure the corneal biomechanics index (CBI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine

  from the date of starting treatment, the corneal biomechanics index was measured 1 week, 1month and every 3 months up to 24 months.

• changes of the stress-strain index in myopic children with different treatment

  the the investigators measure the stress-strain index (SSI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine

  from the date of starting treatment, the stress-strain index (SSI) was measured 1 week, 1month and every 3 months up to 24 months.

Secondary Outcomes (1)

• changes of axial length in myopic children with different treatment

  from the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months

Study Arms (1)

myopic children

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

Device: orthokeratology; Drug: 0.01 atropine

Interventions

orthokeratology DEVICE

orthokeratology wearing for myopia control

myopic children

0.01 atropine DRUG

0.01% atropine eye drop prevent myopic progression

myopic children

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We enroll the clinical patient who recieved orthokeratology or 0.01% atropine for myopia control. Age limits was 8 to 20 year-old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.

You may qualify if:

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

You may not qualify if:

• ocular surface disease( dry eye, keratoconus..)
• allergy to orthokeratology or atropine
• received eye surgery
• strabismus
• premature birth

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Yu-Teng Lai

Yilan, Ilan County, 265, Taiwan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Cheng-Jen Chiu, Doctor

  Tzu Chi genral hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 25, 2021
• Study Start: January 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-09

Locations

TW (1)