Cataract; Eye DiseaseNCT05957796
The Utility of a Novel Eye Shield With Reusable Adhesive Anchors for Post-operative Care After Ophthalmic Surgery
A study testing Novel "Snaps" Eye Shield and Standard Alcon Eye Shield in people with Cataract; Eye Disease, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the efficacy, patient preference, and utility of a novel eye shield that utilizes a different adhesive mechanism in comparison to the current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract; Eye Disease
- What is being tested?
- Novel "Snaps" Eye Shield and Standard Alcon Eye Shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female cataract surgery patients of 18 years or older, with surgical plans for cataract extraction via phacoemulsification and intraocular lens placement. Patient must be having plans to have both eye cataracts removed surgically in succession within 3 months of each other.
Who cannot join
- Patients receiving more advanced intraocular surgery, even if that surgery includes cataract removal and intraocular lens placement, including trabeculectomy, microinvasive glaucoma surgery, vitrectomy, or any other ophthalmic procedure. Pregnancy also an exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Daniel Farrell, MD, 706-721-2020, dafarrell@augusta.edu
About this study
The purpose of this research study is to evaluate the efficacy, patient preference, and utility of a novel eye shield that utilizes a different adhesive mechanism in comparison to the current standard of care. The aims are to see if this product could be incorporated into postoperative care in the future to improve patient satisfaction and compliance.
The study will involve 20 patients during the postoperative timeframe after cataract extraction and intraocular lens placement (CEIOL). These patients will be chosen from the clinic of Dr. Marc Toeteberg who will plan to have both eye surgeries done within 3 months of each other. These patients will be randomized to either control or intervention group. Intervention group will receive our novel eye shield prototype, while control group will receive an Alcon plastic eye shield. Both groups will receive the eye shields after surgery and will be sent home with these eye shields with normal postoperative care directions. Patient will be directed to wear eye shields for 24 hours then at night for first 2 weeks after surgery, while adhering to postoperative eye drops regimen.
After successfully healing and passing the postoperative timeframe for the first eye we will proceed to the second arm of the study. Approximately 1-2 months after healing from the first surgery, patient will be scheduled for cataract surgery on the other eye, as is standard of care. After surgery on the second eye the patient will be given the other eye shield than what they received after the first surgery (control groups will receive the novel eye shield and experimental groups will receive the control eye shield). They will proceed to follow identical postoperative protocols after the second surgery. A short quantitative and qualitative questionnaire directly comparing the two eye shield experiences will be provided at the 1 month follow-up after the eye surgery.
- Conditions
- Cataract; Eye Disease
- Being tested
- Novel "Snaps" Eye Shield, Standard Alcon Eye Shield
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel "Snaps" Eye ShieldDevice
Using a novel eye shield, "Snaps" manufactured in Morgantown, WV by Intermed Labs after cataract surgery that has a different adhesive mechanism that utilizes adhesive and snap-on attachments to the shield.
Standard Alcon Eye ShieldOther
Use normal Alcon eye shield with tape to adhere to shield to eye postop.
| Study group | Role | What they receive |
|---|---|---|
| Regular eye shield after surgery | Active comparator | Alcon eye shield after surgery Receives: Other: Standard Alcon Eye Shield |
| Novel prototype eye shield after surgery | Experimental | Novel prototype eye shield after surgery Receives: Device: Novel "Snaps" Eye Shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of use of a new eye shield versus regular eye shield.
This primarily focuses on comfort and satisfaction to the patient between the two shields. This will be assessed via a questionnaire using a likert scale to get quantitative data from the questions.
Measured: Over the course of the 2 cataract surgeries, approximately taking 3 months including preoperative and postoperative care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract; Eye DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957796
- Sponsor's protocol ID
- 2024576
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of a Novel Eye Shield With Reusable Adhesive Anchors for Post-operative Care After Ophthalmic Surgery
- ClinicalTrials.gov ID
- NCT05957796
- Acronym / sponsor ID
- 2024576
- Conditions
- Cataract; Eye Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the efficacy, patient preference, and utility of a novel eye shield that utilizes a different adhesive mechanism in comparison to the current standard of care. The aims are to see if this product could be incorporated into postoperative care in the future to improve patient satisfaction and compliance.
The study will involve 20 patients during the postoperative timeframe after cataract extraction and intraocular lens placement (CEIOL). These patients will be chosen from the clinic of Dr. Marc Toeteberg who will plan to have both eye surgeries done within 3 months of each other. These patients will be randomized to either control or intervention group. Intervention group will receive our novel eye shield prototype, while control group will receive an Alcon plastic eye shield. Both groups will receive the eye shields after surgery and will be sent home with these eye shields with normal postoperative care directions. Patient will be directed to wear eye shields for 24 hours then at night for first 2 weeks after surgery, while adhering to postoperative eye drops regimen.
After successfully healing and passing the postoperative timeframe for the first eye we will proceed to the second arm of the study. Approximately 1-2 months after healing from the first surgery, patient will be scheduled for cataract surgery on the other eye, as is standard of care. After surgery on the second eye the patient will be given the other eye shield than what they received after the first surgery (control groups will receive the novel eye shield and experimental groups will receive the control eye shield). They will proceed to follow identical postoperative protocols after the second surgery. A short quantitative and qualitative questionnaire directly comparing the two eye shield experiences will be provided at the 1 month follow-up after the eye surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular eye shield after surgery | Active comparator | Other: Standard Alcon Eye ShieldAlcon eye shield after surgery |
| Novel prototype eye shield after surgery | Experimental | Device: Novel "Snaps" Eye ShieldNovel prototype eye shield after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or Female cataract surgery patients of 18 years or older, with surgical plans for cataract extraction via phacoemulsification and intraocular lens placement. Patient must be having plans to have both eye cataracts removed surgically in succession within 3 months of each other.
Key exclusion criteria (1 listed)
- Patients receiving more advanced intraocular surgery, even if that surgery includes cataract removal and intraocular lens placement, including trabeculectomy, microinvasive glaucoma surgery, vitrectomy, or any other ophthalmic procedure. Pregnancy also an exclusion criteria.
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 |
|---|---|---|
| Novel "Snaps" Eye ShieldUsing a novel eye shield, "Snaps" manufactured in Morgantown, WV by Intermed Labs after cataract surgery that has a different adhesive mechanism that utilizes adhesive and snap-on attachments to the shield. | Device | Novel prototype eye shield after surgery |
| Standard Alcon Eye ShieldUse normal Alcon eye shield with tape to adhere to shield to eye postop. | Other | Regular eye shield after surgery |
Primary outcome
Feasibility of use of a new eye shield versus regular eye shield.
Time frame: Over the course of the 2 cataract surgeries, approximately taking 3 months including preoperative and postoperative care.
This primarily focuses on comfort and satisfaction to the patient between the two shields. This will be assessed via a questionnaire using a likert scale to get quantitative data from the questions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel "Snaps" Eye Shield and Standard Alcon Eye Shield in people with Cataract; Eye Disease, run by Augusta University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Farrell, MD ((706) 721-2020, dafarrell@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of use of a new eye shield versus regular eye shield. (time frame: Over the course of the 2 cataract surgeries, approximately taking 3 months including preoperative and postoperative care.). 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 24 Jul 2023.