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OpenTrials
Completed

NCT Number: NCT04340518

Conjunctival Rebound After 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.

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Key information

Conditions

Conjunctival Diseases Eye Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston College of Optometry

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

scleral lens

Device

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

Primary outcomes

  1. Rebound at 120 minutes post-SL removal, Day 4

    Time frame: Measured 120-130 minutes post-SL removal, Day 4

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

Secondary outcomes

  1. Rebound at 120-hours post-SL discontinuation

    Time frame: Measured 115-125 hours post-SL removal

    Conjunctival rebound amount at 120 hours post-removal

  2. Rebound at 168-hours post-SL discontinuation

    Time frame: Measured 160-170 hours post-SL removal

    Conjunctival rebound amount at 168 hours post-removal

  3. Rebound at 144-hours post-SL discontinuation

    Time frame: Measured 140-150 hours post-SL removal

    Conjunctival rebound amount at 144 hours post-removal

  4. Rebound at 72-hours post-SL discontinuation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Measured 40-50 hours post-SL removal

    Conjunctival rebound amount at 48 hours post-removal

  16. Rebound at 96-hours post-SL discontinuation

    Time frame: Measured 90-100 hours post-SL removal

    Conjunctival rebound amount at 96 hours post-removal

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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