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Conjunctival Rebound After Scleral Lens Wear

Primary Purpose

Conjunctival Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scleral lens
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Conjunctival Diseases focused on measuring scleral lenses

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Houston College of Optometry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-scleral lens wear

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rebound at 120-hours post-SL discontinuation
Conjunctival rebound amount at 120 hours post-removal
Rebound at 168-hours post-SL discontinuation
Conjunctival rebound amount at 168 hours post-removal
Rebound at 144-hours post-SL discontinuation
Conjunctival rebound amount at 144 hours post-removal
Rebound at 72-hours post-SL discontinuation
Conjunctival rebound amount at 72 hours post-removal
Rebound at 90 minutes post-SL removal, Day 4
Conjunctival rebound amount at 90 minutes post-removal, Day 4
Rebound at 90 minutes post-SL removal, Day 1
Conjunctival rebound amount at 90 minutes post-removal, Day 1
Rebound at 60 minutes post-SL removal, Day 4
Conjunctival rebound amount at 60 minutes post-removal, Day 4
Rebound at 30 minutes post-SL removal, Day 1
Conjunctival rebound amount at 30 minutes post-removal, Day 1
Rebound at 24-hours post-SL discontinuation
Conjunctival rebound amount at 24 hours post-removal
Rebound at 5 minutes post-SL removal, Day 1
Conjunctival rebound amount at 5 minutes post-removal, Day 1
Rebound at 30 minutes post-SL removal, Day 4
Conjunctival rebound amount at 30 minutes post-removal, Day 4
Rebound at 120 minutes post-SL removal, Day 1
Conjunctival rebound amount at 120 minutes post-removal, Day 1
Rebound at 5 minutes post-SL removal, Day 4
Conjunctival rebound amount at 5 minutes post-removal, Day 4
Rebound at 60 minutes post-SL removal, Day 1
Conjunctival rebound amount at 60 minutes post-removal, Day 1
Rebound at 48-hours post-SL discontinuation
Conjunctival rebound amount at 48 hours post-removal
Rebound at 96-hours post-SL discontinuation
Conjunctival rebound amount at 96 hours post-removal

Full Information

First Posted
February 3, 2020
Last Updated
January 28, 2021
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04340518
Brief Title
Conjunctival Rebound After Scleral Lens Wear
Official Title
Measuring the Recovery of the Conjunctival Tissue After 4 Days of Scleral Lens Wear
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctival Diseases
Keywords
scleral lenses

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-scleral lens wear
Arm Type
Experimental
Arm Description
Normal subjects without ocular diseased who have worn scleral lenses for at least 8 hours.
Intervention Type
Device
Intervention Name(s)
Scleral lens
Intervention Description
Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.
Primary Outcome Measure Information:
Title
Rebound at 120 minutes post-SL removal, Day 4
Description
Conjunctival rebound amount at 120 minutes post-removal, Day 4
Time Frame
Measured 120-130 minutes post-SL removal, Day 4
Secondary Outcome Measure Information:
Title
Rebound at 120-hours post-SL discontinuation
Description
Conjunctival rebound amount at 120 hours post-removal
Time Frame
Measured 115-125 hours post-SL removal
Title
Rebound at 168-hours post-SL discontinuation
Description
Conjunctival rebound amount at 168 hours post-removal
Time Frame
Measured 160-170 hours post-SL removal
Title
Rebound at 144-hours post-SL discontinuation
Description
Conjunctival rebound amount at 144 hours post-removal
Time Frame
Measured 140-150 hours post-SL removal
Title
Rebound at 72-hours post-SL discontinuation
Description
Conjunctival rebound amount at 72 hours post-removal
Time Frame
Measured 60-80 hours post-SL removal
Title
Rebound at 90 minutes post-SL removal, Day 4
Description
Conjunctival rebound amount at 90 minutes post-removal, Day 4
Time Frame
Measured 90-100 minutes post-SL removal, Day 4
Title
Rebound at 90 minutes post-SL removal, Day 1
Description
Conjunctival rebound amount at 90 minutes post-removal, Day 1
Time Frame
Measured 90-100 minutes post-SL removal, Day 1
Title
Rebound at 60 minutes post-SL removal, Day 4
Description
Conjunctival rebound amount at 60 minutes post-removal, Day 4
Time Frame
Measured 60-70 minutes post-SL removal, Day 4
Title
Rebound at 30 minutes post-SL removal, Day 1
Description
Conjunctival rebound amount at 30 minutes post-removal, Day 1
Time Frame
Measured 30-40 minutes post-SL removal, Day 1
Title
Rebound at 24-hours post-SL discontinuation
Description
Conjunctival rebound amount at 24 hours post-removal
Time Frame
Measured 20-30 hours post-SL removal
Title
Rebound at 5 minutes post-SL removal, Day 1
Description
Conjunctival rebound amount at 5 minutes post-removal, Day 1
Time Frame
Measured 5-10 minutes post-SL removal, Day 1
Title
Rebound at 30 minutes post-SL removal, Day 4
Description
Conjunctival rebound amount at 30 minutes post-removal, Day 4
Time Frame
Measured 30-40 minutes post-SL removal, Day 4
Title
Rebound at 120 minutes post-SL removal, Day 1
Description
Conjunctival rebound amount at 120 minutes post-removal, Day 1
Time Frame
Measured 120-130 minutes post-SL removal, Day 1
Title
Rebound at 5 minutes post-SL removal, Day 4
Description
Conjunctival rebound amount at 5 minutes post-removal, Day 4
Time Frame
Measured 5-10 minutes post-SL removal, Day 4
Title
Rebound at 60 minutes post-SL removal, Day 1
Description
Conjunctival rebound amount at 60 minutes post-removal, Day 1
Time Frame
Measured 60-70 minutes post-SL removal, Day 1
Title
Rebound at 48-hours post-SL discontinuation
Description
Conjunctival rebound amount at 48 hours post-removal
Time Frame
Measured 40-50 hours post-SL removal
Title
Rebound at 96-hours post-SL discontinuation
Description
Conjunctival rebound amount at 96 hours post-removal
Time Frame
Measured 90-100 hours post-SL removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Conjunctival Rebound After Scleral Lens Wear

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