Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT05957796

Conditions

Cataract; Eye Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Novel "Snaps" Eye Shield

Standard Alcon Eye Shield

Study Details

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.

Conditions

Cataract; Eye Disease

Study ID

NCT05957796

Start date

Jun 15, 2023

Status verified date

Jul, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Regular eye shield after surgery

Alcon eye shield after surgery

experimental: Novel prototype eye shield after surgery

Novel prototype eye shield after surgery

Interventions

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.

Standard Alcon Eye Shield

Use normal Alcon eye shield with tape to adhere to shield to eye postop.

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. ]

Central Contacts and Locations

Central contacts

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

More Information

Sponsor

Augusta University

Last update posted

Jul 24, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2023-07-24.