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NCT04442464 Clinical Trial

Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Ocular Hypertension Clinical Trial

Official title:
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04442464
Other study ID # 18-004974
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date August 27, 2020

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 1
Est. completion date August 27, 2020
Est. primary completion date August 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Scleral Lens
15.0 mm diagnostic spherical rigid contact lens

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) Intraocular pressure measured in millimeters of mercury (mm Hg) 4 hours
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