Ocular Sticks for Routine Ophthalmic Surgery: A Randomized Controlled Monocentric Trial

Area of Science:

• Ophthalmology
• Surgical Devices
• Medical Technology

Background:

• Ocular sticks are essential for fluid absorption during ophthalmic surgeries.
• Evaluating the performance of Pro-optha® Ocular Sticks against alternatives is crucial for surgical outcomes.

Purpose of the Study:

• To assess the clinical performance, safety, and usability of Pro-optha® Ocular Sticks.
• To compare Pro-optha® Ocular Sticks with an alternative device in routine ophthalmic surgeries.

Main Methods:

• A prospective, randomized study comparing Pro-optha® Ocular Sticks (intervention group) with an alternative stick (comparator group).
• 106 patients undergoing two types of eye surgery were included.
• The study is registered under DRKS00025690.

Main Results:

• Pro-optha® Ocular Sticks showed statistically significant non-inferiority in user satisfaction (p=0.0005).
• Over 98% of users rated both devices as "good" or "very good" for additional endpoints.
• Pro-optha® Ocular Sticks performed better in most additional endpoints and subgroups, with no device-related adverse events.

Conclusions:

• Pro-optha® Ocular Sticks are effective for fluid absorption in ophthalmic procedures.
• The investigational device offers good surgical results, usability, and an excellent safety profile.