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| Name | Class |
|---|---|
| Menicon Co., Ltd. | INDUSTRY |
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The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.
Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orthokeratology lenses | Experimental | Children wearing orthokeratology at night for correcting of refractive error will be study group |
|
| single-vision spectacle lenses | Other | Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orthokeratology lenses | Device | Nightly use of orthokeratology to correct the refractive error for a period of two years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study | Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups | 2 years | |
| Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear |
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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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All subjects who passed the inclusion and exclusion criteria at the baseline visit would be assigend to the treatment according to the randomization log.
Phone screening was conducted on all parents who responded to advertisements in local newspapers during March 2008 and June 2009. Those who passed the screening would be invited to attend the baseline visit at the Optometry Clinic of The Hong Kong Polytechnic University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Orthokeratology Lenses | Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period. |
| FG001 | Single-vision Spectacle Lenses | Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Orthokeratology Lenses | Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period. |
| BG001 | Single-vision Spectacle Lenses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study | Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer. | Posted | Mean | Standard Deviation | mm | 2 years |
|
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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 | Orthokeratology Lenses | Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Pauline Cho | The Hong Kong Polytechnic University | (852) 2766-6100 | sopaulin@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 spectacle lenses | Device | Daily use of spectacles to correct the refractive error for a period of two years |
|
|
| 2 years |
| 22969068 | Result | 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. |
| 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. |
| 23361504 | Derived | Cheung SW, Cho P. Validity of axial length measurements for monitoring myopic progression in orthokeratology. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1613-5. doi: 10.1167/iovs.12-10434. |
| 22390958 | Derived | Chan KY, Cheung SW, Cho P. Clinical performance of an orthokeratology lens fitted with the aid of a computer software in Chinese children. Cont Lens Anterior Eye. 2012 Aug;35(4):180-4. doi: 10.1016/j.clae.2012.01.004. Epub 2012 Mar 3. |
| Lost to Follow-up |
|
Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
|
|
| Secondary | Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups | Not Posted | 2 years |
| Secondary | Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear | Not Posted | 2 years |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Single-vision Spectacle Lenses | Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period. | 0 | 51 | 0 | 51 |
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