Conjunctival Rebound After Scleral Lens Wear

• Sponsor: University of Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT04340518
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conjunctival Diseases	Device: Scleral lens	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective observational studyProspective observational study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Measuring the Recovery of the Conjunctival Tissue After 4 Days of Scleral Lens Wear
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rebound at 120 minutes post-SL removal, Day 4 [Measured 120-130 minutes post-SL removal, Day 4]

   Conjunctival rebound amount at 120 minutes post-removal, Day 4

Secondary Outcome Measures

1. Rebound at 120-hours post-SL discontinuation [Measured 115-125 hours post-SL removal]

   Conjunctival rebound amount at 120 hours post-removal

2. Rebound at 168-hours post-SL discontinuation [Measured 160-170 hours post-SL removal]

   Conjunctival rebound amount at 168 hours post-removal

3. Rebound at 144-hours post-SL discontinuation [Measured 140-150 hours post-SL removal]

   Conjunctival rebound amount at 144 hours post-removal

4. Rebound at 72-hours post-SL discontinuation [Measured 60-80 hours post-SL removal]

   Conjunctival rebound amount at 72 hours post-removal

5. Rebound at 90 minutes post-SL removal, Day 4 [Measured 90-100 minutes post-SL removal, Day 4]

   Conjunctival rebound amount at 90 minutes post-removal, Day 4

6. Rebound at 90 minutes post-SL removal, Day 1 [Measured 90-100 minutes post-SL removal, Day 1]

   Conjunctival rebound amount at 90 minutes post-removal, Day 1

7. Rebound at 60 minutes post-SL removal, Day 4 [Measured 60-70 minutes post-SL removal, Day 4]

   Conjunctival rebound amount at 60 minutes post-removal, Day 4

8. Rebound at 30 minutes post-SL removal, Day 1 [Measured 30-40 minutes post-SL removal, Day 1]

   Conjunctival rebound amount at 30 minutes post-removal, Day 1

9. Rebound at 24-hours post-SL discontinuation [Measured 20-30 hours post-SL removal]

   Conjunctival rebound amount at 24 hours post-removal

10. Rebound at 5 minutes post-SL removal, Day 1 [Measured 5-10 minutes post-SL removal, Day 1]

    Conjunctival rebound amount at 5 minutes post-removal, Day 1

11. Rebound at 30 minutes post-SL removal, Day 4 [Measured 30-40 minutes post-SL removal, Day 4]

    Conjunctival rebound amount at 30 minutes post-removal, Day 4

12. Rebound at 120 minutes post-SL removal, Day 1 [Measured 120-130 minutes post-SL removal, Day 1]

    Conjunctival rebound amount at 120 minutes post-removal, Day 1

13. Rebound at 5 minutes post-SL removal, Day 4 [Measured 5-10 minutes post-SL removal, Day 4]

    Conjunctival rebound amount at 5 minutes post-removal, Day 4

14. Rebound at 60 minutes post-SL removal, Day 1 [Measured 60-70 minutes post-SL removal, Day 1]

    Conjunctival rebound amount at 60 minutes post-removal, Day 1

15. Rebound at 48-hours post-SL discontinuation [Measured 40-50 hours post-SL removal]

    Conjunctival rebound amount at 48 hours post-removal

16. Rebound at 96-hours post-SL discontinuation [Measured 90-100 hours post-SL removal]

    Conjunctival rebound amount at 96 hours post-removal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston College of Optometry	Houston	Texas	United States	77204

Sponsors and Collaborators

• University of Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MKWalker, Instructor, University of Houston
• ClinicalTrials.gov Identifier: NCT04340518
• Other Study ID Numbers: STUDY00001908
• First Posted: Apr 9, 2020
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by MKWalker, Instructor, University of Houston: scleral lenses
• Additional relevant MeSH terms: Conjunctival Diseases

Study Results

No Results Posted as of Jan 29, 2021