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Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.
The purpose of this study is to determine the interval required for the conjunctival tissue to return to its natural shape after scleral lens wear. All study visits will take place at the University of Houston College of Optometry (UHCO). Subjects will be recruited and fitted with scleral lenses to wear during the experimental days. Once the proper fit has been achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and 4th day of lens wear for approximately 2 hours of testing. The subjects will then return every 24-hours for measurements until their conjunctival shape has returned to the original shape. The testing will be done using the sMap scleral topographer, which measures the elevation of the conjunctiva. Testing is non-invasive although it requires instillation of Fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. The total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-scleral lens wear | Experimental | Normal subjects without ocular diseased who have worn scleral lenses for at least 8 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scleral lens | Device | Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rebound at 120 minutes post-SL removal, Day 4 | Conjunctival rebound amount at 120 minutes post-removal, Day 4 | Measured 120-130 minutes post-SL removal, Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Rebound at 120-hours post-SL discontinuation | Conjunctival rebound amount at 120 hours post-removal | Measured 115-125 hours post-SL removal |
| Rebound at 168-hours post-SL discontinuation | Conjunctival rebound amount at 168 hours post-removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
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| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Prospective observational study
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| Measured 160-170 hours post-SL removal |
| Rebound at 144-hours post-SL discontinuation | Conjunctival rebound amount at 144 hours post-removal | Measured 140-150 hours post-SL removal |
| Rebound at 72-hours post-SL discontinuation | Conjunctival rebound amount at 72 hours post-removal | Measured 60-80 hours post-SL removal |
| Rebound at 90 minutes post-SL removal, Day 4 | Conjunctival rebound amount at 90 minutes post-removal, Day 4 | Measured 90-100 minutes post-SL removal, Day 4 |
| Rebound at 90 minutes post-SL removal, Day 1 | Conjunctival rebound amount at 90 minutes post-removal, Day 1 | Measured 90-100 minutes post-SL removal, Day 1 |
| Rebound at 60 minutes post-SL removal, Day 4 | Conjunctival rebound amount at 60 minutes post-removal, Day 4 | Measured 60-70 minutes post-SL removal, Day 4 |
| Rebound at 30 minutes post-SL removal, Day 1 | Conjunctival rebound amount at 30 minutes post-removal, Day 1 | Measured 30-40 minutes post-SL removal, Day 1 |
| Rebound at 24-hours post-SL discontinuation | Conjunctival rebound amount at 24 hours post-removal | Measured 20-30 hours post-SL removal |
| Rebound at 5 minutes post-SL removal, Day 1 | Conjunctival rebound amount at 5 minutes post-removal, Day 1 | Measured 5-10 minutes post-SL removal, Day 1 |
| Rebound at 30 minutes post-SL removal, Day 4 | Conjunctival rebound amount at 30 minutes post-removal, Day 4 | Measured 30-40 minutes post-SL removal, Day 4 |
| Rebound at 120 minutes post-SL removal, Day 1 | Conjunctival rebound amount at 120 minutes post-removal, Day 1 | Measured 120-130 minutes post-SL removal, Day 1 |
| Rebound at 5 minutes post-SL removal, Day 4 | Conjunctival rebound amount at 5 minutes post-removal, Day 4 | Measured 5-10 minutes post-SL removal, Day 4 |
| Rebound at 60 minutes post-SL removal, Day 1 | Conjunctival rebound amount at 60 minutes post-removal, Day 1 | Measured 60-70 minutes post-SL removal, Day 1 |
| Rebound at 48-hours post-SL discontinuation | Conjunctival rebound amount at 48 hours post-removal | Measured 40-50 hours post-SL removal |
| Rebound at 96-hours post-SL discontinuation | Conjunctival rebound amount at 96 hours post-removal | Measured 90-100 hours post-SL removal |