Clinical trial NCT04340518: 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
Overall status: COMPLETED
Phase: NA
Conditions: Conjunctival Diseases
Keywords: scleral lenses
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational study
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Rebound at 120 minutes post-SL removal, Day 4
timeFrame: Measured 120-130 minutes post-SL removal, Day 4
Secondary outcomes:
measure: Rebound at 120-hours post-SL discontinuation
timeFrame: Measured 115-125 hours post-SL removal
measure: Rebound at 168-hours post-SL discontinuation
timeFrame: Measured 160-170 hours post-SL removal
measure: Rebound at 144-hours post-SL discontinuation
timeFrame: Measured 140-150 hours post-SL removal
measure: Rebound at 72-hours post-SL discontinuation
timeFrame: Measured 60-80 hours post-SL removal
measure: Rebound at 90 minutes post-SL removal, Day 4
timeFrame: Measured 90-100 minutes post-SL removal, Day 4
measure: Rebound at 90 minutes post-SL removal, Day 1
timeFrame: Measured 90-100 minutes post-SL removal, Day 1
measure: Rebound at 60 minutes post-SL removal, Day 4
timeFrame: Measured 60-70 minutes post-SL removal, Day 4
measure: Rebound at 30 minutes post-SL removal, Day 1
timeFrame: Measured 30-40 minutes post-SL removal, Day 1
measure: Rebound at 24-hours post-SL discontinuation
timeFrame: Measured 20-30 hours post-SL removal
measure: Rebound at 5 minutes post-SL removal, Day 1
timeFrame: Measured 5-10 minutes post-SL removal, Day 1
measure: Rebound at 30 minutes post-SL removal, Day 4
timeFrame: Measured 30-40 minutes post-SL removal, Day 4
measure: Rebound at 120 minutes post-SL removal, Day 1
timeFrame: Measured 120-130 minutes post-SL removal, Day 1
measure: Rebound at 5 minutes post-SL removal, Day 4
timeFrame: Measured 5-10 minutes post-SL removal, Day 4
measure: Rebound at 60 minutes post-SL removal, Day 1
timeFrame: Measured 60-70 minutes post-SL removal, Day 1
measure: Rebound at 48-hours post-SL discontinuation
timeFrame: Measured 40-50 hours post-SL removal
measure: Rebound at 96-hours post-SL discontinuation
timeFrame: Measured 90-100 hours post-SL removal
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
References: