Trial Outcomes & Findings for Retardation of Myopia in Orthokeratology (NCT NCT00962208)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

2 years

Results posted on

2013-10-28

Participant Flow

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.

All subjects who passed the inclusion and exclusion criteria at the baseline visit would be assigend to the treatment according to the randomization log.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	51	51
Overall Study COMPLETED	37	41
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Could not achieve good vision	9	0
Overall Study Contraindicated to continue study	5	1
Overall Study Lost to Follow-up	0	9

Baseline Characteristics

Retardation of Myopia in Orthokeratology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Orthokeratology Lenses n=51 Participants 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.	Single-vision Spectacle Lenses n=51 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.	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	9.28 years STANDARD_DEVIATION 1.10 • n=5 Participants	9.27 years STANDARD_DEVIATION 1.09 • n=7 Participants	9.28 years STANDARD_DEVIATION 1.09 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment China	51 participants n=5 Participants	51 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome measures
Measure	Orthokeratology Lenses n=37 Participants 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.	Single-vision Spectacle Lenses n=41 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.
Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study	0.36 mm Standard Deviation 0.24	0.63 mm Standard Deviation 0.26

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Orthokeratology Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single-vision Spectacle Lenses

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