Contact Lens Adaptation
Conditions
Keywords
Contact Lenses, Scleral Lenses, Adaptation, Neophyte
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDMV inserter (DMV® MagicTouch™) with an open end
This is a device used to help apply scleral lenses.
DEVICEDMV inserter (DMV® MagicTouch™) with a closed end
This is a device used to help apply scleral lenses.
DEVICEThree fingers (Patient's Hand)
This is a device used to help apply scleral lenses.
DEVICEO-ring (Hardware Store Product)
This is a device used to help apply scleral lenses.
DEVICETea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)
This is a device used to help apply scleral lenses.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Subjects will be assigned to try all five scleral lens application methods in a random order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\>18 years) * Must have an indication for needing scleral lenses
Exclusion criteria
* Participating in another research study * Unable to attend multiple visits * Advanced knowledge or past use of scleral lenses * A physical or mental condition that would prevent the subject from applying their own scleral lenses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scleral Lens Application Time | At Dispense Visit at Hour 0 (Visit 2) | Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Method Preference | At Dispense Visit at Hour 0 (Visit 2) | Patient top ranked preference of scleral lens application method (percent) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | New Scleral Lens Wearers |
|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 20.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: At Dispense Visit at Hour 0 (Visit 2)
Population: Each subject tried all 5 methods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With an Open End | Scleral Lens Application Time | 75.2 minutes | Standard Deviation 20.7 |
| New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With a Closed End | Scleral Lens Application Time | 71.6 minutes | Standard Deviation 25.9 |
| New Scleral Lens Wearers - Three Fingers (Patient's Hand) | Scleral Lens Application Time | 51.3 minutes | Standard Deviation 38.5 |
| New Scleral Lens Wearers - O-ring (Hardware Store Product) | Scleral Lens Application Time | 62.5 minutes | Standard Deviation 37.5 |
| New Scleral Lens Wearer - Tea Light Candle (Generic Deparment Store Product) With DMV Inserter | Scleral Lens Application Time | 63.9 minutes | Standard Deviation 35.7 |
p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary
Subject's Method Preference
Patient top ranked preference of scleral lens application method (percent)
Time frame: At Dispense Visit at Hour 0 (Visit 2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With an Open End | Subject's Method Preference | 1 Participants |
| New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With a Closed End | Subject's Method Preference | 5 Participants |
| New Scleral Lens Wearers - Three Fingers (Patient's Hand) | Subject's Method Preference | 1 Participants |
| New Scleral Lens Wearers - O-ring (Hardware Store Product) | Subject's Method Preference | 2 Participants |
| New Scleral Lens Wearer - Tea Light Candle (Generic Deparment Store Product) With DMV Inserter | Subject's Method Preference | 4 Participants |