A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

Myopic Progression Clinical Trial

Official title:

A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643342
• Other study ID #: HSEARS20150909002
• Status: Completed
• Phase: N/A
• Start date: June 18, 2016
• Est. completion date: August 3, 2019

Study information

• Verified date: February 2020
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 3, 2019
• Est. primary completion date: August 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• 6 to 10 years old

• Myopia: between 0.50 D and 4.00 D in both eyes

• Astigmatism: <1.50 D; = 1.25 D for with-the-rule astigmatism (axes 180 ± 30); = 0.50 D for astigmatism of other axes in both eyes

• Anisometropia: = 1.50 D

• Symmetrical corneal topography with corneal toricity <2.00 D in both eyes

• Agree for randomization

Exclusion Criteria:

• Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)

• Any type of strabismus or amblyopia

• Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period

• Rigid contact lenses (including orthokeratology lenses) experience

• Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)

• Ocular conditions which might affect the refractive error (for example, cataract, ptosis)

• Poor compliance for lens wear or follow-up

Related Conditions & MeSH terms

• Disease Progression
• Myopic Progression

Intervention

Device:
• Orthokeratology

Locations

Country	Name	City	State
China	School of Optometry, The Hong KOng Polytechnic University	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Aston University, Menicon Co., Ltd., Queensland University of Technology

Country where clinical trial is conducted

China, 

References & Publications (8)

Chan B, Cho P, Mountford J. The validity of the Jessen formula in overnight orthokeratology: a retrospective study. Ophthalmic Physiol Opt. 2008 May;28(3):265-8. doi: 10.1111/j.1475-1313.2008.00545.x. — View Citation

Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527. — View Citation

Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. — View Citation

Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565. — View Citation

González-Méijome JM, Villa-Collar C, Queirós A, Jorge J, Parafita MA. Pilot study on the influence of corneal biomechanical properties over the short term in response to corneal refractive therapy for myopia. Cornea. 2008 May;27(4):421-6. doi: 10.1097/ICO.0b013e318164e49d. — View Citation

Lam CS, Lam CH, Cheng SC, Chan LY. Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt. 2012 Jan;32(1):17-24. doi: 10.1111/j.1475-1313.2011.00886.x. — View Citation

Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. — View Citation

Wolffsohn JS, Safeen S, Shah S, Laiquzzaman M. Changes of corneal biomechanics with keratoconus. Cornea. 2012 Aug;31(8):849-54. doi: 10.1097/ICO.0b013e318243e42d. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	axial progression of the eyeball	every 6 monthly in 2 years
Secondary	Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer	ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer	every 6 monthly in 2 years
Secondary	Corneal biomechanics (corneal response using ocular response)	corneal response using ocular response	every 6 monthly in 2 years
Secondary	Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer	accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets	every 6 monthly in 2 years
Secondary	Choroidal thickness captured by Optical Coherent Tomographer (OCT)	choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software	every 6 monthly in 2 years