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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
GroupInterventionDescription
Study EyeScleral LensOne eye will be randomly selected to wear the scleral lenses to be worn during study measurements
Primary Outcome Measures
NameTimeMethod
Intraocular Pressure (IOP)4 hours

Intraocular pressure measured in millimeters of mercury (mm Hg)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

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