Clinical trial NCT03566680: Treating Contact Lens Discomfort With Orthokeratology
Official title: Treating Contact Lens Discomfort With Orthokeratology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Contact Lens Complication
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Orthokeratology has yet to be fully explored for the treatment of contact lens discomfort (CLD), though some support for this practice exists in the literature. Carracedo et al., Lipson et al., and Garcia-Porta et al. found that orthokeratology resulted in better ocular comfort than soft contact lenses. Nevertheless, all three studies excluded subjects who had been diagnosed with dry eye and all three studies used symptoms surveys that were not specific to assessing CLD. Garcia-Porta et al.'s study was also limited by including both neophytes and established contact lens wearers. Yet, these studies overall suggest that orthokeratology could be used as a treatment for CLD, and one case report has even found that orthokeratology is a viable option for treating contact lens intolerance.

To date, there has yet to be a study fully investigating orthokeratology as an alternative to soft contact lens use in patients with CLD. Therefore, the purpose of this study is to formally investigate if orthokeratology is a good alternative to soft contact lenses for patients who are experiencing CLD or for patients who have dropped out of contact lenses because of CLD. This study will also simultaneously evaluate the neophyte orthokeratology wearing experience with hopes of finding additional means for improving contact lens comfort. Knowing the success of orthokeratology in wearers with CLD will allow practitioners to better help and prescribe for those who may have experienced or at risk for experiencing CLD. It may also be a way to allow patients additional years of contact lens wear.

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

Primary outcomes:
measure: Contact Lens Comfort
timeFrame: 1 Month Compared to Baseline
Secondary outcomes:
measure: Contact Lens Comfort
timeFrame: 1 Week Compared to Baseline
measure: Contact Lens Comfort
timeFrame: 3 Month Compared to Baseline
measure: Non-Invasive Tear Break-Up Time
timeFrame: 1 Month Compared to Baseline
measure: Tear Meniscus Height
timeFrame: 1 Month Compared to Baseline
measure: Phenol Red Thread
timeFrame: 1 Month Compared to Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew D Pucker, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duong K, McGwin G Jr, Franklin QX, Cox J, Pucker AD. Treating Uncomfortable Contact Lens Wear With Orthokeratology. Eye Contact Lens. 2021 Feb 1;47(2):74-80. doi: 10.1097/ICL.0000000000000690.