NCT05832749

Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD

Post-market, Prospective, Randomised, Controlled, Masked Clinical Investigation to Compare the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD (Ophthalmic Viscosurgical Device)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 296 (estimated)
• Sponsor: Gemini Eye Clinic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Prospective, randomized, subject/evaluator-masked post market clinical study at up to 2 sites at Gemini eye clinic in Czech Republic. Randomization will be done by the eye surgeon. The purpose of this post market clinical trial is to compare the safety and efficacy of Ophtesis Bio 3% with a similar 3% sodium hyaluronate OVD in routine cataract surgery.

Detailed description

The purpose of this clinical study is to evaluate the performance of the Ophtesis Bio 3%. The primary endpoint is the rate of intraocular pressure (IOP) spikes of 30 mmHG or greater at the 7-day postoperative visit. The secondary endpoint will be the rate of user acceptance evaluated using the surgeon questionnaire at the surgery day visit. Other key endpoints will include IOP and IOP change from baseline at the 7-day postoperative visit, rate of inflammation measured using Slip Lamp at the 7-day postoperative visit, and rates of serious and/or device-related adverse events. Number of Subjects/eyes: Up to 296 eyes will be enrolled to achieve approximately 148 operated eyes per group.

Conditions

• Bilateral Cataract
• Unilateral Cataract

Interventions

Type	Name	Description
DEVICE	Ophtesis Bio 3% ophthalmic viscosurgical device	Intraocular surgery of the anterior segment, including cataract extraction and intraocular lens (IOL) implantation. The viscoelastic properties of OphtesisBio 3.0% allow lubrication, support and protection of ocular tissues during ophthalmic surgery. Maintains the depth of the anterior chamber during surgery, allows for efficient manipulation with reduced trauma to the corneal endothelium and other surrounding tissues.
DEVICE	Healon Endocoat 3% ophthalmic viscosurgical device	Healon@ EndoCoat OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: * Cataract surgery with an intraocular lens * Cataract surgery without an intraocular lens * Secondary intraocular lens implantation Healon@ EndoCoat maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

Timeline

• Start date: 2022-08-23
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2023-04-27
• Last updated: 2023-04-27

Locations

3 sites across 1 country: Czechia