Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

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.

Study Overview

• Status: Terminated
• Conditions: Contact Lens Adaptation
• Intervention / Treatment: Device: DMV inserter (DMV® MagicTouch™) with an open end; Device: DMV inserter (DMV® MagicTouch™) with a closed end; Device: Three fingers (Patient's Hand); Device: O-ring (Hardware Store Product); Device: Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scleral Lens Application Time	Amount of time needed to apply scleral lenses to both eyes (minutes); each patient will try each application method in a random order.	At Dispense Visit at Hour 0 (Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Method Preference	Patient top ranked preference of scleral lens application method (percent)	At Dispense Visit at Hour 0 (Visit 2)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Contact Lenses; Scleral Lenses; Adaptation; Neophyte
• Other Study ID Numbers: IRB-300006015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to sure individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No