Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

NCT04442464 | Terminated Results FDA Device

• 1 other identifier: 18-004974
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  Intraocular pressure measured in millimeters of mercury (mm Hg)

  4 hours

Study Arms (2)

Study Eye

EXPERIMENTAL

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

Device: Scleral Lens

Control Eye

NO INTERVENTION

Non-lens wearing eye

Interventions

Scleral Lens DEVICE

15.0 mm diagnostic spherical rigid contact lens

Study Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 intraocular lens (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

You may not qualify if:

• On topical medication for glaucoma
• Eye disease
• Inability to wear scleral lenses
• Any intraocular surgery other than uncomplicated cataract extraction.
• Known allergy to proparacaine eye drops

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

Study terminated due to lack of recruitment and only one participant was enrolled.

Results Point of Contact

• Title: Cherie B. Nau, O.D.
• Organization: Mayo Clinic

Nau.Cherie@mayo.edu

507-284-4152

Study Officials

• Cherie Nau, OD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2020
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)