Treating Contact Lens Discomfort With Orthokeratology

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Contact Lens Complication
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Orthokeratology Group; All subjects will be fit in orthokeratology contact lenses.	Device: Orthokeratology; Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Comfort	Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-8 (Range = 0 to 28 with lower scores being better). Subjects were required to have Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores of 12 or greater in order to participate in this study.	1 Month Compared to Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Comfort	Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).	1 Week Compared to Baseline
Contact Lens Comfort	Eye comfort will be measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).	3 Month Compared to Baseline
Non-Invasive Tear Break-Up Time	This is a measure of tear stability (Measured in seconds with higher amounts of time being better).	1 Month Compared to Baseline
Tear Meniscus Height	This is a measure of tear volume (Measured in millimeters with higher heights being better).	1 Month Compared to Baseline
Phenol Red Thread	This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).	1 Month Compared to Baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 7, 2018
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): June 15, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (ACTUAL): June 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: OAN 000520524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be shared in aggregate as a published manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No