Conjunctival Rebound After Scleral Lens Wear

Measuring the Recovery of the Conjunctival Tissue After 4 Days of Scleral Lens Wear

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.

Study Overview

• Status: Completed
• Conditions: Conjunctival Diseases
• Intervention / Treatment: Device: Scleral lens

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-scleral lens wear; Normal subjects without ocular diseased who have worn scleral lenses for at least 8 hours.	Device: Scleral lens; Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebound at 120 minutes post-SL removal, Day 4	Conjunctival rebound amount at 120 minutes post-removal, Day 4	Measured 120-130 minutes post-SL removal, Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebound at 120-hours post-SL discontinuation	Conjunctival rebound amount at 120 hours post-removal	Measured 115-125 hours post-SL removal
Rebound at 168-hours post-SL discontinuation	Conjunctival rebound amount at 168 hours post-removal	Measured 160-170 hours post-SL removal
Rebound at 144-hours post-SL discontinuation	Conjunctival rebound amount at 144 hours post-removal	Measured 140-150 hours post-SL removal
Rebound at 72-hours post-SL discontinuation	Conjunctival rebound amount at 72 hours post-removal	Measured 60-80 hours post-SL removal
Rebound at 90 minutes post-SL removal, Day 4	Conjunctival rebound amount at 90 minutes post-removal, Day 4	Measured 90-100 minutes post-SL removal, Day 4
Rebound at 90 minutes post-SL removal, Day 1	Conjunctival rebound amount at 90 minutes post-removal, Day 1	Measured 90-100 minutes post-SL removal, Day 1
Rebound at 60 minutes post-SL removal, Day 4	Conjunctival rebound amount at 60 minutes post-removal, Day 4	Measured 60-70 minutes post-SL removal, Day 4
Rebound at 30 minutes post-SL removal, Day 1	Conjunctival rebound amount at 30 minutes post-removal, Day 1	Measured 30-40 minutes post-SL removal, Day 1
Rebound at 24-hours post-SL discontinuation	Conjunctival rebound amount at 24 hours post-removal	Measured 20-30 hours post-SL removal
Rebound at 5 minutes post-SL removal, Day 1	Conjunctival rebound amount at 5 minutes post-removal, Day 1	Measured 5-10 minutes post-SL removal, Day 1
Rebound at 30 minutes post-SL removal, Day 4	Conjunctival rebound amount at 30 minutes post-removal, Day 4	Measured 30-40 minutes post-SL removal, Day 4
Rebound at 120 minutes post-SL removal, Day 1	Conjunctival rebound amount at 120 minutes post-removal, Day 1	Measured 120-130 minutes post-SL removal, Day 1
Rebound at 5 minutes post-SL removal, Day 4	Conjunctival rebound amount at 5 minutes post-removal, Day 4	Measured 5-10 minutes post-SL removal, Day 4
Rebound at 60 minutes post-SL removal, Day 1	Conjunctival rebound amount at 60 minutes post-removal, Day 1	Measured 60-70 minutes post-SL removal, Day 1
Rebound at 48-hours post-SL discontinuation	Conjunctival rebound amount at 48 hours post-removal	Measured 40-50 hours post-SL removal
Rebound at 96-hours post-SL discontinuation	Conjunctival rebound amount at 96 hours post-removal	Measured 90-100 hours post-SL removal

Collaborators and Investigators

• Sponsor: University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: scleral lenses
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases
• Other Study ID Numbers: STUDY00001908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No