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Scleral Lens for Ocular Hypertension

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every half hour for 4 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every half hour for 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every half hour for 4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every half hour for 4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intraocular Pressure (IOP)

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,990 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available for participation in this trial?

"As detailed on clinicaltrials.gov, this medical research project is currently in the process of enrolment. The trial was made publically available on July 1st 2020 and its most recent update happened April 1st 2022."

Answered by AI

What is the total cohort size for this medical experiment?

"That is correct. Accoring to clinicaltrials.gov, this medical trial was created on July 1st 2020 and last amended on April 1st 2022. Currently, 21 participants are needed from one location for the study's purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Cherie B. Nau 2020. "Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04442464.

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