Conjunctival Rebound After Scleral Lens Wear

Conjunctival Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340518
• Other study ID #: STUDY00001908
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: January 2021
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 30, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Conjunctival Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Houston College of Optometry	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rebound at 120-hours post-SL discontinuation	Conjunctival rebound amount at 120 hours post-removal	Measured 115-125 hours post-SL removal
Secondary	Rebound at 168-hours post-SL discontinuation	Conjunctival rebound amount at 168 hours post-removal	Measured 160-170 hours post-SL removal
Secondary	Rebound at 144-hours post-SL discontinuation	Conjunctival rebound amount at 144 hours post-removal	Measured 140-150 hours post-SL removal
Secondary	Rebound at 72-hours post-SL discontinuation	Conjunctival rebound amount at 72 hours post-removal	Measured 60-80 hours post-SL removal
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rebound at 24-hours post-SL discontinuation	Conjunctival rebound amount at 24 hours post-removal	Measured 20-30 hours post-SL removal
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rebound at 48-hours post-SL discontinuation	Conjunctival rebound amount at 48 hours post-removal	Measured 40-50 hours post-SL removal
Secondary	Rebound at 96-hours post-SL discontinuation	Conjunctival rebound amount at 96 hours post-removal	Measured 90-100 hours post-SL removal