Influence of Corneal Biomechanical Properties on Myopia Control

Myopia Clinical Trial

Official title:

Influence of Corneal Biomechanical Properties on Myopia Reduction and Axial Elongation in Children Using Orthokeratology and 0.01% Atropine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05090592
• Other study ID #: Buddhist TCGH
• Status: Enrolling by invitation
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Buddhist Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• orthokeratology
orthokeratology wearing for myopia control

Drug:
• 0.01 atropine
0.01% atropine eye drop prevent myopic progression

Locations

Country	Name	City	State
Taiwan	Yu-Teng Lai	Yilan	Ilan County

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	changes of axial length in myopic children with different treatment	the investigators measure the axial length(mm) of eyeball of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).	from the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months