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OpenTrials
Completed

NCT Number: NCT03566680

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthokeratology

Device

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.

Primary outcomes

  1. Contact Lens Comfort

    Time frame: 1 Month Compared to Baseline

    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.

Secondary outcomes

  1. Contact Lens Comfort

    Time frame: 1 Week Compared to Baseline

    Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).

  2. Contact Lens Comfort

    Time frame: 3 Month Compared to Baseline

    Eye comfort will be measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).

  3. Non-Invasive Tear Break-Up Time

    Time frame: 1 Month Compared to Baseline

    This is a measure of tear stability (Measured in seconds with higher amounts of time being better).

  4. Tear Meniscus Height

    Time frame: 1 Month Compared to Baseline

    This is a measure of tear volume (Measured in millimeters with higher heights being better).

  5. Phenol Red Thread

    Time frame: 1 Month Compared to Baseline

    This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2018
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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