Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

Not Applicable

Terminated

• Conditions: Contact Lens Adaptation
• Interventions: 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™)

• Registration Number: NCT04583579
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-12
• Study Start: 2021-02-23
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Results First Submitted: 2024-05-03
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Results First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New Scleral Lens Wearers	DMV inserter (DMV® MagicTouch™) with an open end	All patients will be asked to wear scleral lenses for the duration of this study.
New Scleral Lens Wearers	O-ring (Hardware Store Product)	All patients will be asked to wear scleral lenses for the duration of this study.
New Scleral Lens Wearers	DMV inserter (DMV® MagicTouch™) with a closed end	All patients will be asked to wear scleral lenses for the duration of this study.
New Scleral Lens Wearers	Three fingers (Patient's Hand)	All patients will be asked to wear scleral lenses for the duration of this study.
New Scleral Lens Wearers	Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)	All patients will be asked to wear scleral lenses for the duration of this study.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States