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The Utility of a Novel Eye Shield With Reusable Adhesive Anchors for Post-operative Care After Ophthalmic Surgery

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ClinicalTrials.gov Identifier: NCT05957796
Recruitment Status : Recruiting
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
Sponsor:
Information provided by (Responsible Party):
Augusta University

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cataract; Eye Disease Device: Novel "Snaps" Eye Shield Other: Standard Alcon Eye Shield Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Utility of a Novel Eye Shield With Reusable Adhesive Anchors for Post-operative Care After Ophthalmic Surgery
Actual Study Start Date : June 15, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Regular eye shield after surgery
Alcon eye shield after surgery
 Other: Standard Alcon Eye Shield
Use normal Alcon eye shield with tape to adhere to shield to eye postop.
Experimental: Novel prototype eye shield after surgery
Novel prototype eye shield after surgery
 Device: Novel "Snaps" Eye Shield
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05957796


Contacts
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Contact: Daniel Farrell, MD (706) 721-2020 dafarrell@augusta.edu

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Daniel Farrell, MD    706-721-2020    dafarrell@augusta.edu   
Sponsors and Collaborators
Augusta University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT05957796    
Other Study ID Numbers: 2024576
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: July 24, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cataract
Eye Diseases
Lens Diseases