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| Name | Class |
|---|---|
| Menicon Co., Ltd. | INDUSTRY |
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The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses.
Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Both studies showed that the effect of myopic control was most significant during the first six months of the treatment. It is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. The current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. This knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment.
Children who have been on the treatment for two years and have recently completed the myopic control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO studies, will be invited to participate in this 14-month study. Ortho-k subjects will be randomly assigned to study group or the ortho-k control group. The study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (Phase I) and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be required to continue the current treatment for another 14 months. Control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-vision glasses and ortho-k lenses | Experimental | Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months |
|
| ortho-k lenses | Active Comparator | Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group |
|
| single-vision glasses | Other | Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ortho-k lenses | Device | nightly wear of orthokeratology lenses to correct vision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length | To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects | Baseline, 7 months, and 14 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Effects | The observation of serious and non-serious adverse events in the 14 months of study period | 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline Cho, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry, The Hong Kong Polytechnic University | Hong Kong | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15875367 | Background | 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. | |
| 19416935 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-vision Glasses and Ortho-k Lenses | Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision |
| FG001 | Ortho-k Lenses | Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group ortho-k lenses: nightly wear of orthokeratology lenses to correct vision |
| FG002 | Single-vision Glasses | Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group single-vision glasses: daily wear of spectacle glasses to correct vision |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-vision Glasses and Ortho-k Lenses | Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Axial Length | To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects | Posted | Mean | Standard Deviation | mm | Baseline, 7 months, and 14 months after baseline |
|
Adverse effect data were collected within 2 months after completion of the study for subjects on ortho-k. The subjects were asked to return the contact lenses upon completion of the study and were dismissed once their refractive error and corneal shape were stabilized after cessation of ortho-k treatment. The time required was less than 2 months for all subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-vision Glasses and Ortho-k Lenses | Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | Non-systematic Assessment | One subject in test group had to cease ortho-k lens wear due to chalazion in the left eye 2 months before the completion of study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Pauline Cho | The Hong Kong Polytechnic University | +852 2766 6100 | pauline.cho@polyu.edu.hk |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| single-vision glasses | Device | daily wear of spectacle glasses to correct vision |
|
|
| 28038841 | Result | Cho P, Cheung SW. Discontinuation of orthokeratology on eyeball elongation (DOEE). Cont Lens Anterior Eye. 2017 Apr;40(2):82-87. doi: 10.1016/j.clae.2016.12.002. Epub 2016 Dec 27. |
| 36809645 | Derived | Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2. |
| BG001 | Ortho-k Lenses | Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group ortho-k lenses: nightly wear of orthokeratology lenses to correct vision |
| BG002 | Single-vision Glasses | Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group single-vision glasses: daily wear of spectacle glasses to correct vision |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Axial length | Mean | Standard Deviation | mm |
|
| OG002 | Single-vision Glasses | Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group single-vision glasses: daily wear of spectacle glasses to correct vision |
|
|
| Secondary | Incidence of Adverse Effects | The observation of serious and non-serious adverse events in the 14 months of study period | Posted | Count of Participants | Participants | 14 months |
|
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Ortho-k Lenses | Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group ortho-k lenses: nightly wear of orthokeratology lenses to correct vision | 0 | 19 | 0 | 19 |
| EG002 | Single-vision Glasses | Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group single-vision glasses: daily wear of spectacle glasses to correct vision | 0 | 16 | 0 | 16 |
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