Scleral Lens Wearers
Conditions
Brief summary
This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.
Interventions
DEVICEscleral contact lens
Scleral contact lens
Sponsors
Jennifer Fogt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination. 2. Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day. 3. The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance). 4. Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye. 5. Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).
Exclusion criteria
1. Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study. 2. Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis. Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility. 3. Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection. 4. Subjects who are participating in any other clinical trial (FDA or other)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | 1 month after lens is dispensed | Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lens Fitting/Evaluation This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.
scleral contact lens: Scleral contact lens | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Lens Fitting/Evaluation | — |
|---|---|---|
| Age, Customized Age 18 or older | 22 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Time frame: 1 month after lens is dispensed
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lens Fitting/Evaluation | The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | Preferred test lenses to habitual lenses | 15 Participants |
| Lens Fitting/Evaluation | The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | Preferred habitual lenses to test lenses | 2 Participants |
| Lens Fitting/Evaluation | The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | No preference | 4 Participants |