N/A N=46 Treatment

Treating Contact Lens Discomfort With Orthokeratology

Dry Eye · Contact Lens Complication

Bottom Line

View on ClinicalTrials.gov: NCT03566680 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Contact Lens Comfort — 22.03; 9.83 Units on a Scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Orthokeratology (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Contact Lens Comfort	11.72; 4.27	<0.001 sig
SECONDARY Contact Lens Comfort	11.72; 4.27	<0.001 sig
SECONDARY Contact Lens Comfort	11.72; 4.27	<0.001 sig
SECONDARY Non-Invasive Tear Break-Up Time	12.25; 12.60	0.73
SECONDARY Tear Meniscus Height	0.27; 0.26	0.08
SECONDARY Phenol Red Thread	25.75; 27.67	0.72

Summary

The primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.

Eligibility Criteria

Inclusion Criteria

A completed comprehensive eye exam within the past two years
Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months
Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation)
Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder
Keratometry values between 40.00 D and 46.00 D

Exclusion Criteria

Past orthokeratology use
Ocular surgery within the past 12 months
History of severe ocular trauma
Active ocular infection or inflammation
Ocular disease other than dry eye
Accutane or ocular medication use
Pregnant or breast feeding
A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03566680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.