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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthokeratology Group | Experimental | All subjects will be fit in orthokeratology contact lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Pucker, OD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32097182 | Derived | 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. |
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The data will be shared in aggregate as a published manuscript.
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Subjects were recruited if they were in the 18-45 had significant Contact lens dry eye questionnaire 8 (cldeq-8) scores (12 or greater), subjects also had to be previous spectacle or contact lens wearers, and had relatively healthy meidcal history, as well as being able to be fit within the approved fda range for orthok (orthokeratology) lenses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Orthokeratology Group | All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All subjects who fit the screening criteria 18-45 years old, with adequate cldeq-8 scores, and good overall health were allowed to participate in this study regardless of sex race or ethnicity.
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| ID | Title | Description |
|---|---|---|
| BG000 | Orthokeratology Group | All subjects will be fit in orthokeratology contact lenses. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants recruited for this study were required to be within the age ranges of 18-45 with good overall health. Subjects were required to need vision correction, and willing to come in for multiple in person visits during the first month of enrollment. | Posted | Mean | Standard Deviation | Units on a Scale | 1 Month Compared to Baseline |
|
Subjects were required to come in for four in person visits over the course of the first month of this study. However an email containing a survey was sent out after 3 months prior to the subject being exited from the study. During this time subjects were encouraged to contact the Pucker laboratory directly regarding any issues or questions they had about their orthok lenses or their general vision.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orthokeratology Group | All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Pucker | The University of Alabama at Birmingham | 920-579-2900 | apucker@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 1, 2020 | Apr 1, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
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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 |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 1 Week Compared to Baseline |
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| Secondary | 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). | Posted | Mean | Standard Deviation | Score on a Scale | 3 Month Compared to Baseline |
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| Secondary | Non-Invasive Tear Break-Up Time | This is a measure of tear stability (Measured in seconds with higher amounts of time being better). | Posted | Mean | Standard Deviation | Seconds | 1 Month Compared to Baseline |
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| Secondary | Tear Meniscus Height | This is a measure of tear volume (Measured in millimeters with higher heights being better). | Posted | Mean | Standard Deviation | Millimeters | 1 Month Compared to Baseline |
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| Secondary | Phenol Red Thread | This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better). | Posted | Mean | Standard Deviation | Millimeters | 1 Month Compared to Baseline |
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| 0 |
| 46 |
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| 46 |
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