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Scleral Lens for Ocular Hypertension

N/A
Waitlist Available
Led By Cherie Nau, OD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not on topical medication for glaucoma
Be older than 18 years old
Must not have
On topical medication for glaucoma
Any intraocular surgery other than uncomplicated cataract extraction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a scleral contact lens raises intraocular pressure in ocular hypertensive patients.

Who is the study for?
This trial is for adults with ocular hypertension, which means they have high eye pressure. They can join if they've had cataract surgery but not other eye surgeries or treatments for glaucoma. Participants should have a history of wearing contact lenses, just not scleral lenses, and must skip their usual lenses on the study day.
What is being tested?
The study is testing whether wearing a special type of rigid contact lens called a scleral lens affects the pressure inside the eyes of people who already have higher than normal intraocular pressure.
What are the potential side effects?
While specific side effects are not listed, wearing scleral lenses may cause discomfort, redness in the eyes, or potentially increase eye pressure which this study aims to investigate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not using any eye drops for glaucoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am using eye drops for glaucoma.
Select...
I have had eye surgery that was not just for cataracts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intraocular Pressure (IOP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study EyeExperimental Treatment1 Intervention
One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
Group II: Control EyeActive Control1 Intervention
Non-lens wearing eye
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Scleral Lens
2018
N/A
~30

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,123 Total Patients Enrolled
1 Trials studying Ocular Hypertension
100 Patients Enrolled for Ocular Hypertension
Cherie Nau, ODPrincipal InvestigatorMayo Clinic

Media Library

Scleral Lens Clinical Trial Eligibility Overview. Trial Name: NCT04442464 — N/A
Ocular Hypertension Research Study Groups: Study Eye, Control Eye
Ocular Hypertension Clinical Trial 2023: Scleral Lens Highlights & Side Effects. Trial Name: NCT04442464 — N/A
Scleral Lens 2023 Treatment Timeline for Medical Study. Trial Name: NCT04442464 — N/A
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