Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

Contact Lens Adaptation Clinical Trial

Official title:

Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04583579
• Other study ID #: IRB-300006015
• Status: Terminated
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contact Lens Adaptation

Intervention

Device:
• DMV inserter (DMV® MagicTouch™) with an open end
This is a device used to help apply scleral lenses.
• DMV inserter (DMV® MagicTouch™) with a closed end
This is a device used to help apply scleral lenses.
• Three fingers (Patient's Hand)
This is a device used to help apply scleral lenses.
• O-ring (Hardware Store Product)
This is a device used to help apply scleral lenses.
• Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)
This is a device used to help apply scleral lenses.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Scleral Lens Removal Time	Amount of time needed to remove scleral lenses from both eyes for the first time (minutes)	1 day