Conjunctival Rebound After Scleral Lens Wear

NCT ID: NCT04340518

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-05-30

Brief Summary

Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.

Detailed Description

The purpose of this study is to determine the interval required for the conjunctival tissue to return to its natural shape after scleral lens wear. All study visits will take place at the University of Houston College of Optometry (UHCO). Subjects will be recruited and fitted with scleral lenses to wear during the experimental days. Once the proper fit has been achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and 4th day of lens wear for approximately 2 hours of testing. The subjects will then return every 24-hours for measurements until their conjunctival shape has returned to the original shape. The testing will be done using the sMap scleral topographer, which measures the elevation of the conjunctiva. Testing is non-invasive although it requires instillation of Fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. The total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.

Conditions

Conjunctival Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Post-scleral lens wear

Normal subjects without ocular diseased who have worn scleral lenses for at least 8 hours.

Group Type: EXPERIMENTAL

Scleral lens

Intervention Type: DEVICE

Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.

Interventions

Scleral lens

Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Normal ocular surface without conjunctival or scleral disease
• Male or female
• 18 years of age and older prior to the initial visit
• A non-scleral lens wearer.

Exclusion Criteria

• Individuals with anterior segment ocular pathology that may affect intraocular pressure and/or scleral/conjunctival health.
• Individuals with known adverse response to Fluress® ophthalmic drops
• Individuals with a history of habitual scleral lens wear
• If a usable baseline image is unable to be obtained at the initial visit due to small ocular surface area or eyelid anatomy
• Individuals currently taking any ocular medications that could affect intraocular pressure and/or scleral/conjunctival health
• Individuals who have any other conditions or situations which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

MKWalker

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Houston College of Optometry

Houston, Texas, United States

Countries

United States

Other Identifiers

STUDY00001908

Identifier Type: -

Identifier Source: org_study_id