Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04442464
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension	Device: Scleral Lens	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Eye One eye will be randomly selected to wear the scleral lenses to be worn during study measurements	Device: Scleral Lens; 15.0 mm diagnostic spherical rigid contact lens
No Intervention: Control Eye Non-lens wearing eye

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) [Baseline, every half hour for 4 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Cherie Nau, OD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Cherie B. Nau, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04442464
• Other Study ID Numbers: 18-004974
• First Posted: Jun 22, 2020
• Last Update Posted: Apr 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Ocular Hypertension

Study Results

No Results Posted as of Apr 4, 2022