Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-08-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study Eye

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

Group Type EXPERIMENTAL

Scleral Lens

Intervention Type DEVICE

15.0 mm diagnostic spherical rigid contact lens

Control Eye

Non-lens wearing eye

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Scleral Lens

15.0 mm diagnostic spherical rigid contact lens

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No