Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
Not Applicable
Terminated
- Conditions
- Ocular Hypertension
- Interventions
- Device: Scleral Lens
- Registration Number
- NCT04442464
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Eye Scleral Lens One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) 4 hours Intraocular pressure measured in millimeters of mercury (mm Hg)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States