Trial Outcomes & Findings for Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters (NCT NCT02643875)

Results Overview

Maximum plus for maximum visual acuity was used as the criterion for subjective refraction. Spherical equivalent refraction was calculated by adding the sum of the sphere power with half of the cylinder power.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

baseline and one month

Results posted on

2020-09-18

Participant Flow

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

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Orthokeratology Lenses With Different Compression Factors Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
Overall Study STARTED	36 72
Overall Study Received 0.75	36 36
Overall Study Received 1.75 D	36 36
Overall Study COMPLETED	28 56
Overall Study NOT COMPLETED	8 16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Orthokeratology Lenses With Different Compression Factors n=56 eyes Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
Age, Continuous	9.3 years n=28 Participants
Sex: Female, Male Female	16 Participants n=28 Participants
Sex: Female, Male Male	12 Participants n=28 Participants
Spherical equivalent refraction Conventional compression factor (0.75 D)	2.12 D STANDARD_DEVIATION 0.94 • n=28 eyes • Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
Spherical equivalent refraction Increased compression factor (1.75 D)	2.09 D STANDARD_DEVIATION 0.97 • n=28 eyes • Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.

PRIMARY outcome

Timeframe: baseline and one month

Population: Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.

Maximum plus for maximum visual acuity was used as the criterion for subjective refraction. Spherical equivalent refraction was calculated by adding the sum of the sphere power with half of the cylinder power.

Outcome measures

Outcome measures
Measure	Orthokeratology Lenses With Different Compression Factors n=56 eyes Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
Changes in Spherical Equivalent Refraction Conventional compression factor (0.75 D)	2.31 D Standard Deviation 0.88
Changes in Spherical Equivalent Refraction Increased compression factor (1.75 D)	2.52 D Standard Deviation 0.85

SECONDARY outcome

Timeframe: baseline and one month

Population: Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.

The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface.

Outcome measures

Outcome measures
Measure	Orthokeratology Lenses With Different Compression Factors n=56 eyes Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
Changes in Subfoveal Choroidal Thickness Conventional compression factor (0.75 D)	-1 um Standard Deviation 30
Changes in Subfoveal Choroidal Thickness Increased compression factor (1.75 D)	-6 um Standard Deviation 30

SECONDARY outcome

Timeframe: baseline and one month

Population: Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.

Ocular higher order aberrations were measured using Shack-Hartmann aberrometer. The wavefront data was fitted with a sixth order Zernike polynomial over a 5-mm pupil size.

Outcome measures

Outcome measures
Measure	Orthokeratology Lenses With Different Compression Factors n=56 eyes Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject.
Changes in Higher Order Aberrations Increased compression factor (1.75 D)	0.1870 um Standard Error 0.03
Changes in Higher Order Aberrations Conventional compression factor (0.75 D)	0.2830 um Standard Error 0.03

Adverse Events

Conventional Compression Factor (0.75 D)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Increased Compression Factor (1.75 D)

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