Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

The University of Alabama at Birmingham

Status: Terminated

Conditions: Contact Lens Adaptation

Treatments: 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™)

Study type: Interventional

Funder types: Other

Identifiers

NCT04583579

IRB-300006015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

New Scleral Lens Wearers

Experimental group

Description:

All patients will be asked to wear scleral lenses for the duration of this study.

Treatment:

Device: Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)

Device: O-ring (Hardware Store Product)

Device: Three fingers (Patient's Hand)

Device: DMV inserter (DMV® MagicTouch™) with a closed end

Device: DMV inserter (DMV® MagicTouch™) with an open end