Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

Conditions
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Contact Lens Adaptation

Intervention / Treatment
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* 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™)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scleral Lens Removal Time | Amount of time needed to remove scleral lenses from both eyes for the first time (minutes) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses, Scleral Lenses, Adaptation, Neophyte