Trial Outcomes & Findings for Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer (NCT NCT04583579)
NCT ID: NCT04583579
Last Updated: 2024-07-18
Results Overview
Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
At Dispense Visit at Hour 0 (Visit 2)
Results posted on
2024-07-18
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
Baseline characteristics by cohort
| Measure |
New Scleral Lens Wearers
n=17 Participants
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.
|
|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 20.5 • n=39 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At Dispense Visit at Hour 0 (Visit 2)Population: Each subject tried all 5 methods.
Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order.
Outcome measures
| Measure |
New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With an Open End
n=13 Participants
DMV inserter (DMV® MagicTouch™) with an open end: This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With a Closed End
n=13 Participants
DMV inserter (DMV® MagicTouch™) with a closed end: This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearers - Three Fingers (Patient's Hand)
n=13 Participants
Three fingers (Patient's Hand): This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearers - O-ring (Hardware Store Product)
n=13 Participants
O-ring (Hardware Store Product): This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearer - Tea Light Candle (Generic Deparment Store Product) With DMV Inserter
n=13 Participants
Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™): This is a device used to help apply scleral lenses.
|
|---|---|---|---|---|---|
|
Scleral Lens Application Time
|
75.2 minutes
Standard Deviation 20.7
|
71.6 minutes
Standard Deviation 25.9
|
51.3 minutes
Standard Deviation 38.5
|
62.5 minutes
Standard Deviation 37.5
|
63.9 minutes
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: At Dispense Visit at Hour 0 (Visit 2)Patient top ranked preference of scleral lens application method (percent)
Outcome measures
| Measure |
New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With an Open End
n=13 Participants
DMV inserter (DMV® MagicTouch™) with an open end: This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearers - DMV Inserter (DMV® MagicTouch™) With a Closed End
n=13 Participants
DMV inserter (DMV® MagicTouch™) with a closed end: This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearers - Three Fingers (Patient's Hand)
n=13 Participants
Three fingers (Patient's Hand): This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearers - O-ring (Hardware Store Product)
n=13 Participants
O-ring (Hardware Store Product): This is a device used to help apply scleral lenses.
|
New Scleral Lens Wearer - Tea Light Candle (Generic Deparment Store Product) With DMV Inserter
n=13 Participants
Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™): This is a device used to help apply scleral lenses.
|
|---|---|---|---|---|---|
|
Subject's Method Preference
|
1 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
New Scleral Lens Wearers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place