Trial Outcomes & Findings for Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children (NCT NCT01236742)

Results Overview

To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

Baseline, 7 months, and 14 months after baseline

Results posted on

2017-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	18	19	16
Overall Study COMPLETED	15	16	13
Overall Study NOT COMPLETED	3	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-vision Glasses and Ortho-k Lenses n=18 Participants 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	Ortho-k Lenses n=19 Participants 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	Single-vision Glasses n=16 Participants 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	Total n=53 Participants Total of all reporting groups
Age, Continuous	10 years n=5 Participants	11 years n=7 Participants	11 years n=5 Participants	11 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Chinese	18 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	53 Participants n=4 Participants
Region of Enrollment China	18 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	53 Participants n=4 Participants
Axial length	24.83 mm STANDARD_DEVIATION 0.881 • n=5 Participants	24.62 mm STANDARD_DEVIATION 0.772 • n=7 Participants	24.72 mm STANDARD_DEVIATION 0.850 • n=5 Participants	24.72 mm STANDARD_DEVIATION 0.823 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 7 months, and 14 months after baseline

To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects

Outcome measures

Outcome measures
Measure	Single-vision Glasses and Ortho-k Lenses n=15 Participants 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	Ortho-k Lenses n=16 Participants 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	Single-vision Glasses n=13 Participants 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
Change in Axial Length Phase I (first 7 months)	0.153 mm Standard Deviation 0.021	0.087 mm Standard Deviation 0.020	0.082 mm Standard Deviation 0.022
Change in Axial Length Phase II (last 7 months)	0.059 mm Standard Deviation 0.014	0.068 mm Standard Deviation 0.013	0.064 mm Standard Deviation 0.015

SECONDARY outcome

Timeframe: 14 months

The observation of serious and non-serious adverse events in the 14 months of study period

Outcome measures

Outcome measures
Measure	Single-vision Glasses and Ortho-k Lenses n=18 Participants 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	Ortho-k Lenses n=19 Participants 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	Single-vision Glasses n=16 Participants 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
Incidence of Adverse Effects Serious adverse events	0 Participants	0 Participants	0 Participants
Incidence of Adverse Effects non-serious adverse events	1 Participants	0 Participants	0 Participants

Adverse Events

Single-vision Glasses and Ortho-k Lenses

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ortho-k Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single-vision Glasses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single-vision Glasses and Ortho-k Lenses n=18 participants at risk 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	Ortho-k Lenses n=19 participants at risk 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	Single-vision Glasses n=16 participants at risk 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
Eye disorders Chalazion	5.6% 1/18 • Number of events 1 • 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.	0.00% 0/19 • 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.	0.00% 0/16 • 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.

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