Conjunctival Rebound After Scleral Lens Wear

NCT04340518 | Completed FDA Device

• 1 other identifier: STUDY00001908
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctival Diseases

Keywords

scleral lenses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Rebound at 120-hours post-SL discontinuation

  Measured 115-125 hours post-SL removal

• Rebound at 168-hours post-SL discontinuation

  Measured 160-170 hours post-SL removal

• Rebound at 144-hours post-SL discontinuation

  Measured 140-150 hours post-SL removal

• Rebound at 72-hours post-SL discontinuation

  Measured 60-80 hours post-SL removal

• Rebound at 90 minutes post-SL removal, Day 4

  Measured 90-100 minutes post-SL removal, Day 4

Study Arms (1)

Post-scleral lens wear

EXPERIMENTAL

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

Device: Scleral lens

Interventions

Scleral lens DEVICE

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

Post-scleral lens wear

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Conjunctival Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Prospective observational study

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: April 9, 2020
• Study Start: December 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 30, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

US (1)