Contact Lens AdaptationNCT04583579
Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
A study testing DMV inserter (DMV® MagicTouch™) with an open end, DMV inserter (DMV® MagicTouch™) with a closed end and Three fingers (Patient's Hand) in people with Contact Lens Adaptation, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Adaptation
- What is being tested?
- DMV inserter (DMV® MagicTouch™) with an open end, DMV inserter (DMV® MagicTouch™) with a closed end and Three fingers (Patient's Hand)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18 years)
- Must have an indication for needing scleral lenses
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35213
About this study
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.
Read the 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.
- Conditions
- Contact Lens Adaptation
- Being tested
- DMV inserter (DMV® MagicTouch™) with an open end, DMV inserter (DMV® MagicTouch™) with a closed end, Three fingers (Patient's Hand), O-ring (Hardware Store Product), Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)
- Keywords
- Contact Lenses, Scleral Lenses, Adaptation, Neophyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMV inserter (DMV® MagicTouch™) with an open endDevice
This is a device used to help apply scleral lenses.
DMV inserter (DMV® MagicTouch™) with a closed endDevice
This is a device used to help apply scleral lenses.
Three fingers (Patient's Hand)Device
This is a device used to help apply scleral lenses.
O-ring (Hardware Store Product)Device
This is a device used to help apply scleral lenses.
Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)Device
This is a device used to help apply scleral lenses.
| Study group | Role | What they receive |
|---|---|---|
| New Scleral Lens Wearers | Experimental | All patients will be asked to wear scleral lenses for the duration of this study. Receives: 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™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Dispense Visit at Hour 0 (Visit 2)
Secondary outcomes (1)
Subject's Method Preference
Patient top ranked preference of scleral lens application method (percent)
Measured: At Dispense Visit at Hour 0 (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start23 Feb 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: Principal investigator ended full-time appointment at university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contact Lens AdaptationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be assigned to try all five scleral lens application methods in a random order.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Pucker, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583579
- Sponsor's protocol ID
- IRB-300006015
- Status last verified
- Jul 2024
- First submitted
- 23 Sep 2020
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to sure individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer
- ClinicalTrials.gov ID
- NCT04583579
- Acronym / sponsor ID
- IRB-300006015
- Conditions
- Contact Lens Adaptation
- Keywords
- Contact Lenses, Scleral Lenses, Adaptation, Neophyte
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator ended full-time appointment at university.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be assigned to try all five scleral lens application methods in a random order.
| Arm | Type | Receives |
|---|---|---|
| New Scleral Lens Wearers | Experimental | 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™)All patients will be asked to wear scleral lenses for the duration of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (>18 years)
- Must have an indication for needing scleral lenses
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMV inserter (DMV® MagicTouch™) with an open endThis is a device used to help apply scleral lenses. | Device | New Scleral Lens Wearers |
| DMV inserter (DMV® MagicTouch™) with a closed endThis is a device used to help apply scleral lenses. | Device | New Scleral Lens Wearers |
| Three fingers (Patient's Hand)This is a device used to help apply scleral lenses. | Device | New Scleral Lens Wearers |
| O-ring (Hardware Store Product)This is a device used to help apply scleral lenses. | Device | New Scleral Lens Wearers |
| Tea light candle (Generic Deparment Store Product) with DMV inserter (DMV® MagicTouch™)This is a device used to help apply scleral lenses. | Device | New Scleral Lens Wearers |
Primary outcome
Scleral Lens Application Time
Time frame: 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.
1 secondary outcome
Subject's Method Preference
Time frame: At Dispense Visit at Hour 0 (Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan to sure individual participant data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMV inserter (DMV® MagicTouch™) with an open end, DMV inserter (DMV® MagicTouch™) with a closed end and Three fingers (Patient's Hand) in people with Contact Lens Adaptation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scleral Lens Application Time (time frame: At Dispense Visit at Hour 0 (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.