Trial Outcomes & Findings for Effectiveness of Orthokeratology in Myopia Control (NCT NCT03465748)
NCT ID: NCT03465748
Last Updated: 2023-09-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
2 years
Results posted on
2023-09-28
Participant Flow
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.
Participant milestones
| Measure |
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. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. 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.
|
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. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. 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
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
18
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Orthokeratology in Myopia Control
Baseline characteristics by cohort
| Measure |
Experimental-OrthoK
n=27 Participants
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.
|
Control
n=18 Participants
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.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
18 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
spherical equivalent refractive error
|
2.69 Diopters
n=99 Participants
|
3.50 Diopters
n=107 Participants
|
3.18 Diopters
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Axial length was measured in mm, many subjects withdrew from the study due to patient/parent scheduling
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.
Outcome measures
| Measure |
Experimental-OrthoK
n=15 Participants
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. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. 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.
|
Control
n=7 Participants
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. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. 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
|
|---|---|---|
|
Axial Length
|
25.32 mm
Interval 25.07 to 26.23
|
26.08 mm
Interval 25.59 to 26.74
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental-OrthoK
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=14 participants at risk
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. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. 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
|
Experimental-OrthoK
n=27 participants at risk
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. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. 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.
|
|---|---|---|
|
Eye disorders
Corneal Binding
|
0.00%
0/14 • At each examination over the course of the 24 month study, subjects were asked about any adverse events.
If any adverse events were identified, subjects were asked to notify the principal investigator.
|
3.7%
1/27 • Number of events 1 • At each examination over the course of the 24 month study, subjects were asked about any adverse events.
If any adverse events were identified, subjects were asked to notify the principal investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place