Dry Eye, Contact Lens Complication
Conditions
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.
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.
Interventions
DEVICEOrthokeratology
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Comfort | 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
| Measure | Time frame | Description |
|---|---|---|
| Non-Invasive Tear Break-Up Time | 1 Month Compared to Baseline | This is a measure of tear stability (Measured in seconds with higher amounts of time being better). |
| Contact Lens Comfort | 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). |
| Tear Meniscus Height | 1 Month Compared to Baseline | This is a measure of tear volume (Measured in millimeters with higher heights being better). |
| Phenol Red Thread | 1 Month Compared to Baseline | This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Orthokeratology Group | — |
|---|---|---|
| Age, Continuous | 24.22 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 46 Participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
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.
Time frame: 1 Month Compared to Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthokeratology Group | Contact Lens Comfort | Baseline | 22.03 Units on a Scale | Standard Deviation 5.47 |
| Orthokeratology Group | Contact Lens Comfort | 1 Month | 9.83 Units on a Scale | Standard Deviation 5.37 |
p-value: <0.001t-test, 2 sided
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).
Time frame: 1 Week Compared to Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthokeratology Group | Contact Lens Comfort | Baseline | 11.72 score on a scale | Standard Deviation 2.59 |
| Orthokeratology Group | Contact Lens Comfort | 1 week | 7.44 score on a scale | Standard Deviation 3.55 |
p-value: <0.001t-test, 2 sided
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).
Time frame: 3 Month Compared to Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthokeratology Group | Contact Lens Comfort | Baseline | 11.72 Score on a Scale | Standard Deviation 2.59 |
| Orthokeratology Group | Contact Lens Comfort | 3 months | 4.27 Score on a Scale | Standard Deviation 3.52 |
p-value: <0.001t-test, 2 sided
Secondary
Non-Invasive Tear Break-Up Time
This is a measure of tear stability (Measured in seconds with higher amounts of time being better).
Time frame: 1 Month Compared to Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthokeratology Group | Non-Invasive Tear Break-Up Time | Baseline | 12.25 Seconds | Standard Deviation 6.28 |
| Orthokeratology Group | Non-Invasive Tear Break-Up Time | 1 month | 12.60 Seconds | Standard Deviation 5.67 |
p-value: 0.73t-test, 2 sided
Secondary
Phenol Red Thread
This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).
Time frame: 1 Month Compared to Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthokeratology Group | Phenol Red Thread | Baseline | 25.75 Millimeters | Standard Deviation 9.19 |
| Orthokeratology Group | Phenol Red Thread | 1 Month | 27.67 Millimeters | Standard Deviation 8.57 |
p-value: 0.72t-test, 2 sided
Secondary
Tear Meniscus Height
This is a measure of tear volume (Measured in millimeters with higher heights being better).
Time frame: 1 Month Compared to Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthokeratology Group | Tear Meniscus Height | Baseline | 0.27 Millimeters | Standard Deviation 0.09 |
| Orthokeratology Group | Tear Meniscus Height | 1 Month | 0.26 Millimeters | Standard Deviation 0.07 |
p-value: 0.08t-test, 2 sided