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

Last updated: July 14, 2023
Sponsor: Augusta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

Standard Alcon Eye Shield

Novel "Snaps" Eye Shield

Clinical Study ID

NCT05957796
2024576
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female cataract surgery patients of 18 years or older, with surgical plans forcataract extraction via phacoemulsification and intraocular lens placement. Patientmust be having plans to have both eye cataracts removed surgically in successionwithin 3 months of each other.

Exclusion

Exclusion Criteria:

  • Patients receiving more advanced intraocular surgery, even if that surgery includescataract removal and intraocular lens placement, including trabeculectomy,microinvasive glaucoma surgery, vitrectomy, or any other ophthalmic procedure.Pregnancy also an exclusion criteria.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Standard Alcon Eye Shield
Phase:
Study Start date:
June 15, 2023
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

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