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Principal investigator ended full-time appointment at university.
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The goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying scleral lenses and factors associated with successfully completing scleral lens application and removal training.
Scleral lens (SL) prescribing has dramatically increased over the past few years likely because of the advent of better SL designs, better materials, and greater awareness of the technology. SL market growth has also likely increased because SLs were once reserved for patients with complex ocular surface diseases, though advances with SL technologies have allowed SL fitting to include patients with dry eye and even patients who have relatively uncomplicated refractive errors. While SLs are maintained and cared for much like soft contact lenses (e.g., they require a contact lens care system), SL wearers also need help with applying their lenses. Patients specifically are advised by their care provider to insert their SLs with their fingers (tripod method), a DMV inserter with an open or closed end (hole potentially aides in vision), or a specialized o-ring that is balanced on a finger. Our clinic also utilizes a tea light candle with a DMV inserter attached to the top of it when patients have mobility issues. While work from this investigator's study group has found that 54% of patients prefer DMV inserters for applying their SLs as compared to the above other options, these preliminary data were obtained through a cross-sectional electronic survey from subjects who completed their SL fitting up to two years ago. Therefore, the goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying SLs and factors associated with successfully completing SL application and removal training. These data are needed because it will help practitioners with patient education and because it may increase the likelihood that patients will be successful with SLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Scleral Lens Wearers | Experimental | All patients will be asked to wear scleral lenses for the duration of this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMV inserter (DMV® MagicTouch™) with an open end | Device | This is a device used to help apply scleral lenses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Scleral Lens Application Time | Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order. | At Dispense Visit at Hour 0 (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Method Preference | Patient top ranked preference of scleral lens application method (percent) | At Dispense Visit at Hour 0 (Visit 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35213 | United States |
We do not plan to sure individual participant data.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Scleral Lens Wearers | All patients will be asked to wear scleral lenses for the duration of this study. DMV inserter (DMV® MagicTouch™) with an open end: This is a device used to help apply scleral lenses. DMV inserter (DMV® MagicTouch™) with a closed end: This is a device used to help apply scleral lenses. Three fingers (Patient's Hand): This is a device used to help apply scleral lenses. O-ring (Hardware Store Product): This is a device used to help apply scleral lenses. Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™): This is a device used to help apply scleral lenses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2020 |
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Subjects will be assigned to try all five scleral lens application methods in a random order.
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| DMV inserter (DMV® MagicTouch™) with a closed end | Device | This is a device used to help apply scleral lenses. |
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| Three fingers (Patient's Hand) | Device | This is a device used to help apply scleral lenses. |
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| O-ring (Hardware Store Product) | Device | This is a device used to help apply scleral lenses. |
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| Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™) | Device | This is a device used to help apply scleral lenses. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Scleral Lens Wearers | All patients will be asked to wear scleral lenses for the duration of this study. DMV inserter (DMV® MagicTouch™) with an open end: This is a device used to help apply scleral lenses. DMV inserter (DMV® MagicTouch™) with a closed end: This is a device used to help apply scleral lenses. Three fingers (Patient's Hand): This is a device used to help apply scleral lenses. O-ring (Hardware Store Product): This is a device used to help apply scleral lenses. Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™): This is a device used to help apply scleral lenses. |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Scleral Lens Application Time | Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order. | Each subject tried all 5 methods. | Posted | Mean | Standard Deviation | minutes | At Dispense Visit at Hour 0 (Visit 2) |
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| Secondary | Subject's Method Preference | Patient top ranked preference of scleral lens application method (percent) | Posted | Count of Participants | Participants | At Dispense Visit at Hour 0 (Visit 2) |
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About 3 months
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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 | New Scleral Lens Wearers | All subjects will be asked to wear scleral lenses for the duration of this study. All subjects tried all interventions during the same session, so it is not possible to separate subjects into different groups. Each subject tried the following interventions on the same day within minutes of each other: DMV inserter (DMV® MagicTouch™) with an open end: This is a device used to help apply scleral lenses. DMV inserter (DMV® MagicTouch™) with a closed end: This is a device used to help apply scleral lenses. Three fingers (Patient's Hand): This is a device used to help apply scleral lenses. O-ring (Hardware Store Product): This is a device used to help apply scleral lenses. Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™): This is a device used to help apply scleral lenses. | 0 | 17 | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Pucker | Lexitas Pharma Services | 9205792900 | andrewpucker@hotmail.com |
| Jun 22, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 24, 2020 | Jun 22, 2024 | ICF_002.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| New Scleral Lens Wearer - Tea Light Candle (Generic Deparment Store Product) With DMV Inserter |
Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™): This is a device used to help apply scleral lenses. |
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