The future of corneal refractive reshaping: can we control myopia or is the risk of corneal compromise too great?

Not Applicable

Completed

• Conditions: Progressing mild childhood myopia; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12608000007336
• Lead Sponsor: Prof Helen Swarbrick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Participants will be required to have myopic refractive error between -1.00 and -4.00D at the time of study enrolment, evidence of progression of myopia over the previous 12 months, <0.75D refractive difference between the two eyes, <1.50D with-the-rule corneal astigmatism, and no against-the-rule astigmatism. Subjects must be of East Asian ethnicity, have good general and ocular health, and no history of rigid contact lens wear. Normal corneal topography, normal binocular function, and vision correctable to 6/9 (20/30) or better are also required for study enrolment.

Exclusion Criteria

Potential subjects will not be enrolled if they show any contraindications for rigid contact lens wear, abnormal binocular function, anisometropia > 0.75D, ocular pathology or active ocular surface disease that would preclude contact lens wear.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome variable will be axial length change as measured using the IOLMaster ocular biometer.[Axial length will be measured at baseline, and 3, 6, 9 and 12 months after commencement of lens wear.]

Secondary Outcome Measures

Name	Time	Method
The relative rate of corneal epithelial cell exfoliation during gentle eye wash with sterile saline, and the amount of bacterial binding to harvested epithelial cells will be determined using a previously published method (Ren et al, 1999).[Cell exfoliation rate and bacterial binding will be determined at baseline, and 3, 6, 9 and 12 months after commencement of lens wear.];Peripheral refractive status will be determined at 10 degree intervals out to 30 degrees along the horizontal meridian using a Shin-Nippon NVision K5001 autorefractor.[Peripheral refraction will be measured at baseline, and 3, 6, 9 and 12 months after commencement of lens wear.]