Ocular Hypertension
Conditions
Brief summary
The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.
Detailed description
This is a randomized, self-controlled study designed to compare effectiveness of a scleral lens on intraocular pressure. In this study, all participants have one eye randomly selected to wear the scleral lenses during study measurements and the other eye serves as the control, non-lens wearing eye.
Interventions
DEVICEScleral Lens
15.0 mm diagnostic spherical rigid contact lens
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ocular hypertension (IOP \>22 in each eye during at least two visits over the previous 3 years) * May have had cataract extraction and intraocular lens (IOL) * Not on topical medication for glaucoma * No History of ALT/SLT * Any Age, 18 years or older * History of contact lens wear (except scleral lenses), as long as they are willing to not wear their lenses the day of the study
Exclusion criteria
* On topical medication for glaucoma * Eye disease * Inability to wear scleral lenses * Any intraocular surgery other than uncomplicated cataract extraction. * Known allergy to proparacaine eye drops
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | 4 hours | Intraocular pressure measured in millimeters of mercury (mm Hg) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants had one eye randomly selected to wear the scleral lenses during study measurements and the other eye served as the control, non-lens wearing eye.
Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 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 | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Intraocular Pressure (IOP)
Intraocular pressure measured in millimeters of mercury (mm Hg)
Time frame: 4 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Eye | Intraocular Pressure (IOP) | Baseline | 24.0 mmHg |
| Study Eye | Intraocular Pressure (IOP) | 4 hours | 21.2 mmHg |
| Control Eye | Intraocular Pressure (IOP) | Baseline | 23.5 mmHg |
| Control Eye | Intraocular Pressure (IOP) | 4 hours | 21.5 mmHg |