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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04293328
Other study ID # HSEARS20190926004-2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 7, 2020
Est. completion date August 2023

Study information

Verified date July 2022
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The two-year prospective study aims at investigating frequently replacement effect on myopia control in young children, and the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit.


Description:

In this two-year prospective study, low myopic children, aged 6-8 years, who have no prior experience in contact lens wear and myopia control treatment will be recruited. They will be prescribed with monthly replacement orthokeratology lenses for a period of one year. Axial elongation and ocular conditions during the study will be determined. Subjects will be randomly assigned to normal cleaning and intensive cleaning groups. Subjects in normal cleaning group will be provided with complimentary contact lenses solutions for daily cleaning and disinfection. In addition to the daily procedures for lens case, subjects in the intensive cleaning group will be required to perform weekly protein removal.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date August 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - Aged 6-10 years - Normal ocular and general condition and not on medication which may contraindicate ortho-k lens wear - Refractive sphere between -0.75 to -4.00 D, refractive cylinder = -1.50 D and anisometropia = -1.00 D - Best correctable vision better than 0.08 logMAR in the worse eye - Normal binocular function and accommodative status - No prior experience in contact lens wear and myopia control treatment Exclusion Criteria: - Strabismus at distance or near - Contraindication for ortho-k lens wear - Prior history of ocular surgery, trauma, or chronic ocular disease - Systemic or ocular conditions that may interfere refractive development - Systemic or ocular conditions that may interfere tear quality and contact lens wear - Poor response to the use of study lenses - Poor compliance to test procedures - Poor compliance to the use of ortho-k lenses (e.g. use of solution, use of lenses) - Poor compliance to follow-up schedule

Study Design


Related Conditions & MeSH terms


Intervention

Device:
orthokeratology
Nightly wear of orthokeratology lenses to correct vision in the daytime
Menicon Progent A+B
Menicon Progent A+B is a commercially available protein remover for rigid lenses. It has received FDA clearance and been launched in Hong Kong for over a decade. The product contains two separate sterile solutions, one with sodium hypochlorite and the other with potassium bromide. By mixing the two solutions in a special vial, it can clean and remove protein deposits on the lenses. Parents of subjects assigned to use weekly protein remover will be required to soak the cleansed lenses in the solution mixture for not more than 30 mins every week. All lenses must be rinsed thoroughly with saline and cleansed with daily cleaner again before daily disinfection.

Locations

Country Name City State
Hong Kong School of Optometry, The Hong Kong Polytechnic University Kowloon

Sponsors (2)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Menicon Co., Ltd.

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

Cheung SW, Boost MV, Cho P. Pre-treatment observation of axial elongation for evidence-based selection of children in Hong Kong for myopia control. Cont Lens Anterior Eye. 2019 Aug;42(4):392-398. doi: 10.1016/j.clae.2018.10.006. Epub 2018 Oct 24. — View Citation

Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565. — View Citation

Hiraoka T, Kakita T, Okamoto F, Takahashi H, Oshika T. Long-term effect of overnight orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up study. Invest Ophthalmol Vis Sci. 2012 Jun 22;53(7):3913-9. doi: 10.1167/iovs.11-8453. — View Citation

Lee YC, Wang JH, Chiu CJ. Effect of Orthokeratology on myopia progression: twelve-year results of a retrospective cohort study. BMC Ophthalmol. 2017 Dec 8;17(1):243. doi: 10.1186/s12886-017-0639-4. — View Citation

Stapleton F, Carnt N. Contact lens-related microbial keratitis: how have epidemiology and genetics helped us with pathogenesis and prophylaxis. Eye (Lond). 2012 Feb;26(2):185-93. doi: 10.1038/eye.2011.288. Epub 2011 Dec 2. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Axial elongation in 2 years Elongation of the eyeball in 24 months 12 months
Primary Changes in Back Surface Lens Deposits Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe Every month up to 24 months
Secondary Number of participants with serious adverse effects in 2 years Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva in 12 months 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04295707 - Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers N/A
Completed NCT02643342 - A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye N/A
Completed NCT02643875 - Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters N/A
Recruiting NCT05192824 - Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality N/A