ClinicalTrials.Veeva

Menu

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

T

The Hong Kong Polytechnic University

Status

Completed

Conditions

Myopic Progression

Treatments

Device: Orthokeratology

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02643342
HSEARS20150909002

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

6 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

99 participants in 3 patient groups

Single-vision glasses
No Intervention group
Description:
Subjects wearing single-vision glasses CR-39 of refractive index 1.56.
Orthokeratology with normal compression factor
Sham Comparator group
Description:
Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D.
Treatment:
Device: Orthokeratology
Orthokeratology with increased compression factor
Active Comparator group
Description:
Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D.
Treatment:
Device: Orthokeratology

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems