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Effectiveness of Orthokeratology in Myopia Control

Effectiveness of Orthokeratology in Myopia Control

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03465748
Enrollment
45
Registered
2018-03-14
Start date
2017-05-01
Completion date
2021-12-01
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

The high prevalence of myopia - especially in Asian countries - is well documented, as are the sight-threatening complications of high or degenerative myopia. Retinal detachment, glaucoma, vitreal degeneration and focal retinal changes may occur secondary to the progressive axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to moderate amounts of myopia. Most of the studies on orthokeratology were conducted on Asian children. To the best of the investigators knowledge, no study has been done on African American (AA) children. The investigators' project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in AA children compared to that in other races.

Detailed description

Orthokeratology (ortho-k), when used for partial or full correction of myopia, has been shown to slow myopic progression in children by 36-56% as compared to their spectacle or contact-lens wearing peers.1 This effect is achieved by limiting the axial elongation of the eye,1, 2,3, 4 which is of particular concern in high myopes (\>6.00D) and children, where myopic progression has been shown to proceed at a faster rate than average.1 As early intervention is considered beneficial if not essential, Ortho-k as a treatment modality for diminishing myopic progression has, to our knowledge, been studied mostly in Asian children. The safety and efficacy of ortho-k as a means of decreasing myopic progression was well established by the Children's Overnight Orthokeratology Investigation (COOKI), who evaluated refractive error, visual changes and ocular health over a period of 6 months in myopic children. 7 The Longitudinal Orthokeratology Research in Children (LORIC) study looked at axial elongation in children as old as 12 years, and found that ortho-k decreased axial elongation by approximately 50% compared to be-spectacled controls. 2 They also noted, however, high variability amongst the children that limits the clinician's ability to predict the outcome of the intervention.2 The Corneal Reshaping and Yearly Observation of Myopia (CRAYON) study confirmed that patients fit with ortho-k lenses showed less change in axial length and vitreous chamber depth when compared to subjects wearing soft contact lenses. 3 Other more recent studies by Santodomingo-Rubido et al, 7 Kakita et al4 and Charm et al1 confirm this decrease in axial elongation using IOL Master measurements. The most commonly accepted theory on how orthokeratology decreases axial elongation relies on the peripheral defocus created on the retina by the corneal changes made by the rigid lens. 9 Hoogerheide et al showed that those at greatest risk for myopic progression were those whose peripheral refraction was hypermetropic10 - that is, they had a hyperopic peripheral 'defocus'. A number of studies have since suggested that treatment approaches to myopia correction should address this peripheral refraction as a means of slowing further axial elongation.9 When looking at subjects treated with ortho k, we see that the lenses do in fact introduce a peripheral myopic defocus while leaving the central refraction more or less emmetropic. 9 With this study, the investigators hope to expand potential application of orthokeratology to a novel population, AA children.

Interventions

DEVICEOrthoK

orthok (orthokeratology) is the science of changing the curvature or shape of the cornea to change how light is focused on the retina at the back of one's eye. Specially designed molding retainer contact lenses are placed on the eye at night and are removed upon awakening.

Sponsors

Wesley Research Institute
CollaboratorOTHER
Illinois College of Optometry
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* myopia progression more than -1.00D in one year * myopic prescription between -1.00D and -6.00D in at least one eye with refractive astigmatism \<1.50D * Best corrected VA 20/25 or better * subjects willing to present to clinic for all necessary follow up care * willing to be randomized to either group

Exclusion criteria

* non-compliance with treatment protocol * contraindications for orthok as per company guidelines * history of refractive surgery * current gas permeable contact lens wearers

Design outcomes

Primary

MeasureTime frameDescription
Axial Length2 yearsAxial Length was measured at baseline and again at the 2 year mark. Units are given in mm. The average of axial length at the 2 year period is provided.

Countries

United States

Participant flow

Recruitment details

A randomized control study at the Illinois Eye Institute using a single-masked design to investigate axial elongation and myopic progression in children wearing ortho-k lenses (study group) versus single-vision spectacles or soft contact lenses (control group) for a period of twenty-four months (May 2017 to January 2021) There was a delay in the recruitment and some subjects lost to follow up due to COVID.

Participants by arm

ArmCount
Experimental-OrthoK
The study will be a randomized control study using a single-masked design to investigate axial elongation and myopic progression in children wearing ortho-k lenses (study group) versus single-vision spectacles or soft contact lenses (control group) for a period of 24 months. Once eligibility has been determined by an unmasked observer, patients will be randomly assigned to either the orthokeratology group or the single-vision contact lens /spectacle group OrthoK: orthok (orthokeratology) is the science of changing the curvature or shape of the cornea to change how light is focused on the retina at the back of one's eye. Specially designed molding retainer contact lenses are placed on the eye at night and are removed upon awakening.
27
Control
The study will be a randomized control study using a single-masked design to investigate axial elongation and myopic progression in children wearing ortho-k lenses (study group) versus single-vision spectacles (control group) for a period of 24 months. Once eligibility has been determined by an unmasked observer, patients will be randomly assigned to either the orthokeratology group or the single-vision contact lens /spectacle group.
18
Total45

Baseline characteristics

CharacteristicExperimental-OrthoKControlTotal
Age, Categorical
<=18 years
27 Participants18 Participants45 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants1 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants17 Participants39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
14 Participants9 Participants23 Participants
Race (NIH/OMB)
Black or African American
6 Participants7 Participants13 Participants
Race (NIH/OMB)
More than one race
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
3 Participants1 Participants4 Participants
Region of Enrollment
United States
27 participants18 participants45 participants
Sex: Female, Male
Female
15 Participants9 Participants24 Participants
Sex: Female, Male
Male
12 Participants9 Participants21 Participants
spherical equivalent refractive error2.69 Diopters3.50 Diopters3.18 Diopters

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 14
other
Total, other adverse events
1 / 270 / 14
serious
Total, serious adverse events
0 / 270 / 14

Outcome results

Primary

Axial Length

Axial Length was measured at baseline and again at the 2 year mark. Units are given in mm. The average of axial length at the 2 year period is provided.

Time frame: 2 years

Population: Axial length was measured in mm, many subjects withdrew from the study due to patient/parent scheduling

ArmMeasureValue (MEAN)
Experimental-OrthoKAxial Length25.32 mm
ControlAxial Length26.08 mm

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026