Trial Outcomes & Findings for Discontinuation of Lens Wear in New Ortho-k Children (DOEE2) (NCT NCT01236755)
NCT ID: NCT01236755
Last Updated: 2020-03-11
Results Overview
Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
14 months
Results posted on
2020-03-11
Participant Flow
Participant milestones
| Measure |
Subjects in Spectacle and Ortho-k Wearing Phases
Subjects enrolled in the study during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
|
|---|---|
|
Spectacles Wearing Phase
STARTED
|
91
|
|
Spectacles Wearing Phase
COMPLETED
|
74
|
|
Spectacles Wearing Phase
NOT COMPLETED
|
17
|
|
Orthokeratology Wearing Phase
STARTED
|
74
|
|
Orthokeratology Wearing Phase
COMPLETED
|
66
|
|
Orthokeratology Wearing Phase
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Subjects in Spectacle and Ortho-k Wearing Phases
Subjects enrolled in the study during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
|
|---|---|
|
Spectacles Wearing Phase
Withdrawal by Subject
|
8
|
|
Spectacles Wearing Phase
Lost to Follow-up
|
9
|
|
Orthokeratology Wearing Phase
Withdrawal by Subject
|
5
|
|
Orthokeratology Wearing Phase
Poor Refractive Correction / Centration
|
3
|
Baseline Characteristics
Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)
Baseline characteristics by cohort
| Measure |
Subjects Completed the 14-month Study
n=66 Participants
Subjects who have completed the study in which they used single-vision spectacles every day for 7 months in Phase I and ortho-k lenses every night for the next 7 months in Phase II to correct their vision.
|
|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 monthsAxial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology
Outcome measures
| Measure |
Axial Elongation in Spectacle and Ortho-k Wearing Phases
n=66 Participants
Axial elongation in children during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
|
|---|---|
|
Change in Axial Elongation in the Two Study Phases
spectacles wearing phase
|
0.163 mm
Standard Deviation 0.121
|
|
Change in Axial Elongation in the Two Study Phases
orthokeratology wearing phase
|
0.047 mm
Standard Deviation 0.112
|
SECONDARY outcome
Timeframe: 14 monthsNumber of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva
Outcome measures
| Measure |
Axial Elongation in Spectacle and Ortho-k Wearing Phases
n=66 Participants
Axial elongation in children during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
|
|---|---|
|
Number of Participants With Serious Adverse Effects
spectacles wearing phase
|
0 Participants
|
|
Number of Participants With Serious Adverse Effects
orthokeratology wearing phase
|
0 Participants
|
Adverse Events
Serious Adverse Events in Spectacle and Ortho-k Wearing Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof Pauline Cho
The Hong Kong Polytechnic University
Phone: +852 2766-6100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place