Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Mayo Clinic

Status: Terminated

Conditions: Ocular Hypertension

Treatments: Device: Scleral Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT04442464

18-004974

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Study Eye

Experimental group

Description:

One eye will be randomly selected to wear the scleral lenses to be worn during study measurements

Treatment:

Device: Scleral Lens

Control Eye

No Intervention group

Description:

Non-lens wearing eye