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Myopic Control for High Myopes Using Orthokeratology (HM-PRO)

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Orthokeratology lenses

Single-vision spectacle lenses

About this trial

This is an interventional treatment trial for Myopia focused on measuring children, corneal reshaping, myopia, myopia control, orthokeratology

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Myopia (refractive sphere): > 5.75D
Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
Spherical equivalent (SE): > 5.75D
Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
Willingness for randomization
Availability for follow-up for at least 2 years

Exclusion Criteria:

Strabismus at distance or near
Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)

Sites / Locations

School of Optometry, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Orthokeratology lenses

Single-vision spectacle lenses

Arm Description

Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group

Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group

Outcomes

Primary Outcome Measures

Determine the change in cycloplegic axial length in the study and control groups

Secondary Outcome Measures

Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups

Rate of regression during the daytime

Full Information

NCT ID

NCT00977236

First Posted

September 14, 2009

Last Updated

July 11, 2013

Sponsor

The Hong Kong Polytechnic University

Collaborators

Procornea Nederland B.V.

1. Study Identification

Unique Protocol Identification Number

NCT00977236

Brief Title

Myopic Control for High Myopes Using Orthokeratology

Acronym

HM-PRO

Official Title

High Myopia - Partial Reduction Orthokeratology Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

Collaborators

Procornea Nederland B.V.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

Detailed Description

Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment? A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

children, corneal reshaping, myopia, myopia control, orthokeratology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orthokeratology lenses

Arm Type

Experimental

Arm Description

Children wearing orthokeratology at night for partial correction and spectacles at daytime for residual refractive error will be study group

Arm Title

Single-vision spectacle lenses

Arm Type

Other

Arm Description

Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group

Intervention Type

Device

Intervention Name(s)

Orthokeratology lenses

Other Intervention Name(s)

Corneal reshaping therapy

Intervention Description

Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years

Intervention Type

Device

Intervention Name(s)

Single-vision spectacle lenses

Other Intervention Name(s)

Glasses, Spectacles

Intervention Description

Daily use of spectacles to correct the refractive error for a period of two years

Primary Outcome Measure Information:

Title

Determine the change in cycloplegic axial length in the study and control groups

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Determine the incidence of adverse effects in cornea, the palpebral, bulbar and tarsal conjunctiva in the study and the control groups

Time Frame

2 years

Title

Rate of regression during the daytime

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Myopia (refractive sphere): > 5.75D Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D Spherical equivalent (SE): > 5.75D Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes Willingness for randomization Availability for follow-up for at least 2 years Exclusion Criteria: Strabismus at distance or near Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication) Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pauline Cho

Organizational Affiliation

The Hong Kong Polytechnic University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Optometry, The Hong Kong Polytechnic University

City

Hong Kong SAR

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

15875367

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. doi: 10.1080/02713680590907256.

Results Reference

result

PubMed Identifier

19416935

Citation

Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.

Results Reference

result

PubMed Identifier

23645372

Citation

Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.

Results Reference

result

PubMed Identifier

23518209

Citation

Charm J, Cho P. High myopia-partial reduction orthokeratology (HM-PRO): study design. Cont Lens Anterior Eye. 2013 Aug;36(4):164-70. doi: 10.1016/j.clae.2013.02.012. Epub 2013 Mar 18.

Results Reference

result

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/23645372

Description

High myopia-partial reduction ortho-k: a 2-year randomized study

URL

http://www.ncbi.nlm.nih.gov/pubmed/23518209

Description

High myopia-partial reduction orthokeratology (HM-PRO): Study design.

Learn more about this trial

Myopic Control for High Myopes Using Orthokeratology

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