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
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Contact Lens Complication||Device: Orthokeratology||Not Applicable|
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 (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)|
|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|
Experimental: Orthokeratology Group
All subjects will be fit in orthokeratology contact lenses.
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.
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|