Trial Outcomes & Findings for Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study (NCT NCT04308941)
NCT ID: NCT04308941
Last Updated: 2023-11-09
Results Overview
Intraocular pressure will be measured using one of three different tonometers. The reproducibility of measurements on each device will be studied.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
patient will participate for 1 hour
Results posted on
2023-11-09
Participant Flow
Participant milestones
| Measure |
Scleral Tonopen
The first 10 subjects will be randomly chosen for the first cohort (scleral TonoPen)
Intraocular pressure: The intraocular pressure will be measured using one of three devices
|
Scleral Pneumatonometer
The second 10 subjects will be randomly chosen for the second cohort (scleral pneumatonometry)
Intraocular pressure: The intraocular pressure will be measured using one of three devices
|
Diaton
The third 10 subjects will be randomly chosen for the third cohort (Diaton).
Intraocular pressure: The intraocular pressure will be measured using one of three devices
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Scleral Tonopen
n=10 Participants
IOP for this group is measured using a scleral tonopen
|
Scleral Pneumatonometry
n=10 Participants
IOP for this group is measured using scleral pneumatonometry
|
Diaton
n=10 Participants
IOP for this group is measured using Diaton
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
29 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Age, Continuous
|
44.80 years
STANDARD_DEVIATION 10.14 • n=10 Participants
|
50.80 years
STANDARD_DEVIATION 7.74 • n=10 Participants
|
46.77 years
STANDARD_DEVIATION 10.82 • n=10 Participants
|
47.33 years
STANDARD_DEVIATION 9.67 • n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
16 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
30 participants
n=30 Participants
|
|
mean IOP
|
24.23 mmHg
STANDARD_DEVIATION 8.59 • n=10 Participants
|
22.32 mmHg
STANDARD_DEVIATION 6.41 • n=10 Participants
|
24.52 mmHg
STANDARD_DEVIATION 12.20 • n=10 Participants
|
23.275 mmHg
STANDARD_DEVIATION 7.5 • n=30 Participants
|
PRIMARY outcome
Timeframe: patient will participate for 1 hourPopulation: Participants were 18 years of age or older and were recruited from a pool of current clinic patients who carried the diagnosis of corneal ectasia and were established bilateral wearers of a PROSE device.
Intraocular pressure will be measured using one of three different tonometers. The reproducibility of measurements on each device will be studied.
Outcome measures
| Measure |
Tonopen
n=10 Participants
IOP reproducibility evaluated using Tonopen
|
Scleral Pneumotonometry
n=10 Participants
IOP reproducibility evaluated using Pneumatonometry
|
Diaton
n=10 Participants
IOP reproducibility evaluated using Diaton
|
|---|---|---|---|
|
The Goal of This Research is to Determine the Reproducibility of Measurements of Intraocular Pressure (IOP) When a Scleral Lens is on the Eye.
|
24.23 mmHg
Standard Deviation 8.59
|
22.32 mmHg
Standard Deviation 6.41
|
24.52 mmHg
Standard Deviation 12.20
|
Adverse Events
Scleral Tonopen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Scleral Pneumatonometry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diaton
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