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

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 Overview

• Status: Recruiting
• Conditions: Cataract; Eye Disease
• Intervention / Treatment: Other: Standard Alcon Eye Shield; Device: Novel "Snaps" Eye Shield

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Farrell, MD; Phone Number: (706) 721-2020; Email: dafarrell@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
      • Contact: Daniel Farrell, MD; Phone Number: 706-721-2020; Email: dafarrell@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Over the course of the 2 cataract surgeries, approximately taking 3 months including preoperative and postoperative care.

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lens Diseases; Eye Diseases; Cataract
• Other Study ID Numbers: 2024576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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