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Completed

NCT Number: NCT02719535

Corneal Biomechanics and Corneal Reshaping Therapy

The aim of the proposed study is to investigate the predictive value of corneal biomechanical properties in corneal reshaping therapy and the role of these parameters in determining the amount of myopia reduction.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Kowloon, HKG, Hong Kong

About this study

Experiment 1: To evaluate changes in corneal biomechanics caused by short-term corneal reshaping therapy.

Subjects will wear a conventional RGP lens in one eye, randomly selected, and an orthokeratology lens in the fellow eye, for 30 minutes, 60 minutes and one night, respectively. Corneal stiffness and tangent modulus will be measured before and after each wearing period.

Experiment 2: To evaluate changes in and the recovery of corneal biomechanics effected by long-term corneal reshaping and to assess whether corneal biomechanics can predict the rate of corneal reshaping.

Subjects will wear orthokeratology lenses for 6 months. Regular follow up visits (1 week, 1 month, 3 months and 6 months) will be arranged to monitor the changes in corneal stiffness and tangent modulus.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myopia between -4D to -5D, with-the-rule astigmatism not more than 1.5D, spherical equivalent between -4D to -5.75D, difference between two eyes within 1D, best corrected spectacle visual acuity 0.10 logMAR in each eye

Exclusion criteria

  • previous corneal reshaping therapy, long-term contact lens wear, ocular disease

Treatment and study plan

Corneal reshaping therapy

Other

Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses

Primary outcomes

  1. Change of Corneal Stiffness From Baseline at 6 Months

    Time frame: At baseline, then change from baseline to 6 months

    Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.

Secondary outcomes

  1. Change of Tangent Modulus From Baseline at 6 Months

    Time frame: At baseline, then change from baseline to 6 months

    Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Corneal Stiffness and Tangent Modulus to Predict the Rate of Corneal Curvature Change in Corneal Reshaping Therapy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2016
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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