Conjunctival Rebound After Scleral Lens Wear

University of Houston

Status

Completed

Conditions

Conjunctival Diseases

Treatments

Device: Scleral lens

Study type

Interventional

Funder types

Other

Identifiers

NCT04340518

STUDY00001908

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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