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Treating Contact Lens Discomfort With Orthokeratology

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ClinicalTrials.gov Identifier: NCT03566680
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Pucker, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Dry Eye Contact Lens Complication Device: Orthokeratology Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Contact Lens Discomfort With Orthokeratology
Actual Study Start Date : August 7, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. Eye Comfort [ Time Frame: 1 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).

  2. Quality of Life While Wearing Contact Lenses [ Time Frame: 1 month compared to baseline ]
    Quality of life will be measured with the University of Michigan Vision Correction Quality of Life survey (Range = 0 to 100 with higher scores being better).


Secondary Outcome Measures :
  1. Eye Comfort [ Time Frame: 1 week 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).

  2. Eye Comfort [ Time Frame: 3 months 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 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566680


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Andrew Pucker, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03566680     History of Changes
Other Study ID Numbers: OAN 000520524
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be shared in aggregate as a published manuscript.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No