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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Subjects will be assigned to try all five scleral lens application methods in a random order.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
New Scleral Lens Wearers 		All patients will be asked to wear scleral lenses for the duration of this study.
  • Device: DMV inserter (DMV® MagicTouch™) with an open end
    This is a device used to help apply scleral lenses.
  • Device: DMV inserter (DMV® MagicTouch™) with a closed end
    This is a device used to help apply scleral lenses.
  • Device: Three fingers (Patient's Hand)
    This is a device used to help apply scleral lenses.
  • Device: O-ring (Hardware Store Product)
    This is a device used to help apply scleral lenses.
  • Device: Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)
    This is a device used to help apply scleral lenses.

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.