Clinical trial NCT04583579: Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
Official title: Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contact Lens Adaptation
Keywords: Contact Lenses
Scleral Lenses
Adaptation
Neophyte
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be assigned to try all five scleral lens application methods in a random order.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying scleral lenses and factors associated with successfully completing scleral lens application and removal training.

Detailed description: Scleral lens (SL) prescribing has dramatically increased over the past few years likely because of the advent of better SL designs, better materials, and greater awareness of the technology. SL market growth has also likely increased because SLs were once reserved for patients with complex ocular surface diseases, though advances with SL technologies have allowed SL fitting to include patients with dry eye and even patients who have relatively uncomplicated refractive errors. While SLs are maintained and cared for much like soft contact lenses (e.g., they require a contact lens care system), SL wearers also need help with applying their lenses. Patients specifically are advised by their care provider to insert their SLs with their fingers (tripod method), a DMV inserter with an open or closed end (hole potentially aides in vision), or a specialized o-ring that is balanced on a finger. Our clinic also utilizes a tea light candle with a DMV inserter attached to the top of it when patients have mobility issues. While work from this investigator's study group has found that 54% of patients prefer DMV inserters for applying their SLs as compared to the above other options, these preliminary data were obtained through a cross-sectional electronic survey from subjects who completed their SL fitting up to two years ago. Therefore, the goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying SLs and factors associated with successfully completing SL application and removal training. These data are needed because it will help practitioners with patient education and because it may increase the likelihood that patients will be successful with SLs.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years)
* Must have an indication for needing scleral lenses

Exclusion Criteria:

* Participating in another research study
* Unable to attend multiple visits
* Advanced knowledge or past use of scleral lenses
* A physical or mental condition that would prevent the subject from applying their own scleral lenses

Primary outcomes:
measure: Scleral Lens Application Time
timeFrame: At Dispense Visit at Hour 0 (Visit 2)
Secondary outcomes:
measure: Subject's Method Preference
timeFrame: At Dispense Visit at Hour 0 (Visit 2)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: