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Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

Primary Purpose

Ocular Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scleral Lens
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Eye

Control Eye

Arm Description

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

Non-lens wearing eye

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)
Change in intraocular pressure measured in millimeters of mercury (mm Hg)

Secondary Outcome Measures

Full Information

First Posted
June 18, 2020
Last Updated
February 3, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04442464
Brief Title
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
Official Title
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Eye
Arm Type
Experimental
Arm Description
One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
Arm Title
Control Eye
Arm Type
No Intervention
Arm Description
Non-lens wearing eye
Intervention Type
Device
Intervention Name(s)
Scleral Lens
Intervention Description
15.0 mm diagnostic spherical rigid contact lens
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Change in intraocular pressure measured in millimeters of mercury (mm Hg)
Time Frame
Baseline, every half hour for 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherie Nau, OD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherie Nau, OD
Phone
507-284-3614
Email
nau.cherie@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

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