- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442464
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
February 3, 2023 updated by: Cherie B. Nau, Mayo Clinic
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Cherie Nau, OD
- Phone Number: 507-284-3614
- Email: nau.cherie@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Study Eye
One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
|
15.0 mm diagnostic spherical rigid contact lens
|
NO_INTERVENTION: Control Eye
Non-lens wearing eye
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure (IOP)
Time Frame: Baseline, every half hour for 4 hours
|
Change in intraocular pressure measured in millimeters of mercury (mm Hg)
|
Baseline, every half hour for 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cherie Nau, OD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2020
Primary Completion (ANTICIPATED)
January 1, 2025
Study Completion (ANTICIPATED)
January 1, 2025
Study Registration Dates
First Submitted
June 18, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (ACTUAL)
June 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-004974
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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