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Orthokeratology for High Myopia (OHM) Study

Primary Purpose

Myopia, High Myopia

Status

Recruiting

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

ortho-k lenses and thinner spectacles

newly designed ortho-k lenses

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia control, Orthokeratology, Children

Eligibility Criteria

7 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Myopia: at least 5.00D in one eye or in both eyes
Astigmatism: ≤1.50D; with-the-rule astigmatism (axes 180 ± 30) ≤1.25D; astigmatism of other axes ≤0.50D in both eyes
Anisometropia: not be more than 1.00D in the former and not more than 2.00D in the latter.
Best-corrected Monocular Snellen visual acuity 6/7.5 or better

Exclusion Criteria:

Strabismus at distance or near
Previous experience in contact lens wear or myopia control treatment (e.g. refractive therapy or progressive spectacles)
Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
Previous history of ocular surgery, trauma, or chronic ocular disease
Concurrent use of medications that may affect tear quality or contact lens wear
Systemic or ocular conditions that may affect tear quality or contact lens wear (e.g allergy and concurrent medication) or that may affect refractive development (e.g Down syndrome, ptosis)
Poor compliance to tests (e.g poor fixation in noncontact tonometry or intolerance of lens wear)
Not willing to comply with the allocated treatment, use and care of lenses and follow-up schedule

Sites / Locations

School of Optometry, The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ortho-k lenses and thinner spectacles

newly designed ortho-k lenses

Arm Description

participants using conventionally designed ortho-k lenses (target for 4.00D) and thinner spectacles during day time

participants using newly designed ortho-k lenses for high myopia (target for full correction)

Outcomes

Primary Outcome Measures

Change in axial length elongation over 24 months.

To determine the change in axial length measured at baseline and two years after lens wear using IOLMaster

Secondary Outcome Measures

First fit success rate of a newly designed ortho-k lens for high myopic children

The success rate in using the first pair of lenses to achieve target refractive correction will be determined

Quality of life (questionnaire)

Quality of life will be determined by questionnaires (using revised Pediatric Refractive Error Profile (PREP) 1 in traditional Chinese version) before and after ortho-k in the two groups of subjects

Ocular aberration

Ocular aberration will be measured by Complete Ophthalmic Analysis System (COAS) aberrometer

Full Information

NCT ID

NCT03881358

First Posted

February 21, 2019

Last Updated

February 14, 2021

Sponsor

The Hong Kong Polytechnic University

Collaborators

Queensland University of Technology, Aston University

1. Study Identification

Unique Protocol Identification Number

NCT03881358

Brief Title

Orthokeratology for High Myopia (OHM) Study

Official Title

Orthokeratology for High Myopia (OHM) Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 4, 2018 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

Collaborators

Queensland University of Technology, Aston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This project aims to investigate/examine high myopic subjects on full correction ortho-k (using Topaz ortho-k lenses for high myopia) compared to subjects undergoing partial reduction ortho-k and their relationship with myopia and myopic progression.

Detailed Description

For many years, commercially-available ortho-k lenses aim to reduce low - moderate myopia. Attempts to use these lenses for reduction of high myopia have been shown to give rise to complications such as corneal staining and lens decentration. Thus, practitioners may choose a more conservative way for high myopic children, that is, offering partial reduction ortho-k. Partial reduction ortho-k is target for 4.00-5.00D reduction and the residual refractive errors will be corrected with single vision spectacles to allow good visual acuity in the daytime. Partial reduction ortho-k has been shown to slow axial elongation in high myopic children, however, the main disadvantage is that the children have to wear spectacles in the daytime to correct residual refraction. Euclid has recently designed a new lens, Euclid's Topaz, for high myopic children. It is currently commercially available to correct myopia for up to 10 D. However, evidence of its effectiveness for visual correction and slowing AL growth is lacking. While numerous studies have shown that orthokeratology is an effective clinical treatment to slow axial eye growth in children, the exact mechanism underlying this reduction in myopia progression associated with orthokeratology remains unclear.

6. Conditions and Keywords

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

Myopia, High Myopia

Keywords

Myopia control, Orthokeratology, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ortho-k lenses and thinner spectacles

Arm Type

Active Comparator

Arm Description

participants using conventionally designed ortho-k lenses (target for 4.00D) and thinner spectacles during day time

Arm Title

newly designed ortho-k lenses

Arm Type

Experimental

Arm Description

participants using newly designed ortho-k lenses for high myopia (target for full correction)

Intervention Type

Device

Intervention Name(s)

ortho-k lenses and thinner spectacles

Intervention Description

Conventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time

Intervention Type

Device

Intervention Name(s)

newly designed ortho-k lenses

Intervention Description

Newly designed (Topaz) ortho-k lenses for high myopia (target for full correction)

Primary Outcome Measure Information:

Title

Change in axial length elongation over 24 months.

Description

To determine the change in axial length measured at baseline and two years after lens wear using IOLMaster

Time Frame

2 years

Secondary Outcome Measure Information:

Title

First fit success rate of a newly designed ortho-k lens for high myopic children

Description

The success rate in using the first pair of lenses to achieve target refractive correction will be determined

Time Frame

1 month

Title

Quality of life (questionnaire)

Description

Quality of life will be determined by questionnaires (using revised Pediatric Refractive Error Profile (PREP) 1 in traditional Chinese version) before and after ortho-k in the two groups of subjects

Time Frame

3 months

Title

Ocular aberration

Description

Ocular aberration will be measured by Complete Ophthalmic Analysis System (COAS) aberrometer

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Myopia: at least 5.00D in one eye or in both eyes Astigmatism: ≤1.50D; with-the-rule astigmatism (axes 180 ± 30) ≤1.25D; astigmatism of other axes ≤0.50D in both eyes Anisometropia: not be more than 1.00D in the former and not more than 2.00D in the latter. Best-corrected Monocular Snellen visual acuity 6/7.5 or better Exclusion Criteria: Strabismus at distance or near Previous experience in contact lens wear or myopia control treatment (e.g. refractive therapy or progressive spectacles) Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex) Previous history of ocular surgery, trauma, or chronic ocular disease Concurrent use of medications that may affect tear quality or contact lens wear Systemic or ocular conditions that may affect tear quality or contact lens wear (e.g allergy and concurrent medication) or that may affect refractive development (e.g Down syndrome, ptosis) Poor compliance to tests (e.g poor fixation in noncontact tonometry or intolerance of lens wear) Not willing to comply with the allocated treatment, use and care of lenses and follow-up schedule

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pauline Cho, PhD

Phone

(+852) 2766 6100

pauline.cho@polyu.edu.hk

First Name & Middle Initial & Last Name or Official Title & Degree

Yajing Yang, BSc

Phone

(+852) 6486 2435

grace.yj.yang@connect.polyu.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pauline Cho, PhD

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

Kowloon

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pauline Cho, PhD

Phone

(+852)2766 6100

pauline.cho@polyu.edu.hk

First Name & Middle Initial & Last Name & Degree

Yajing Yang, BSc

Phone

(+852)6486 2435

grace.yj.yang@connect.polyu.hk

First Name & Middle Initial & Last Name & Degree

Pauline Cho, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

15181356

Citation

Lam CS, Goldschmidt E, Edwards MH. Prevalence of myopia in local and international schools in Hong Kong. Optom Vis Sci. 2004 May;81(5):317-22. doi: 10.1097/01.opx.0000134905.98403.18.

Results Reference

background

PubMed Identifier

22161388

Citation

Walline JJ, Lindsley K, Vedula SS, Cotter SA, Mutti DO, Twelker JD. Interventions to slow progression of myopia in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD004916. doi: 10.1002/14651858.CD004916.pub3.

Results Reference

background

PubMed Identifier

21212181

Citation

Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.

Results Reference

background

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

background

PubMed Identifier

16637967

Citation

Swarbrick HA. Orthokeratology review and update. Clin Exp Optom. 2006 May;89(3):124-43. doi: 10.1111/j.1444-0938.2006.00044.x.

Results Reference

background

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

background

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

background

PubMed Identifier

12568650

Citation

Cho P, Cheung SW, Edwards MH. Practice of orthokeratology by a group of contact lens practitioners in Hong Kong. Part 2: orthokeratology lenses. Clin Exp Optom. 2003 Jan;86(1):42-6. doi: 10.1111/j.1444-0938.2003.tb03056.x.

Results Reference

background

PubMed Identifier

23662961

Citation

Lee TT, Cho P. Relative peripheral refraction in children: twelve-month changes in eyes with different ametropias. Ophthalmic Physiol Opt. 2013 May;33(3):283-93. doi: 10.1111/opo.12057.

Results Reference

background

PubMed Identifier

26397463

Citation

Atchison DA, Li SM, Li H, Li SY, Liu LR, Kang MT, Meng B, Sun YY, Zhan SY, Mitchell P, Wang N. Relative Peripheral Hyperopia Does Not Predict Development and Progression of Myopia in Children. Invest Ophthalmol Vis Sci. 2015 Sep 1;56(10):6162-70. doi: 10.1167/iovs.15-17200.

Results Reference

background

PubMed Identifier

15767050

Citation

Hiraoka T, Matsumoto Y, Okamoto F, Yamaguchi T, Hirohara Y, Mihashi T, Oshika T. Corneal higher-order aberrations induced by overnight orthokeratology. Am J Ophthalmol. 2005 Mar;139(3):429-36. doi: 10.1016/j.ajo.2004.10.006.

Results Reference

background

PubMed Identifier

18434845

Citation

Gonzalez-Meijome JM, Villa-Collar C, Queiros 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.

Results Reference

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Orthokeratology for High Myopia (OHM) Study

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