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

NCT ID: NCT05832749

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 296 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2023-05-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Product: Ophtesis Bio 3%

Subjects to receive Ophtesis Bio 3% in one eye

Ophtesis Bio 3% ophthalmic viscosurgical device

Intervention Type: 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.

Control Product: Healon Endocoat 3%

Subjects to receive Healon Endocoat 3% in one eye

Healon Endocoat 3% ophthalmic viscosurgical device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent

Exclusion Criteria

• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Use of systemic or ocular medications that may affect IOP
• Known steroid responder
• Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemini Eye Clinic

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Pavel Stodulka

Chief eye surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel Stodulka, MD

Role: PRINCIPAL_INVESTIGATOR

Gemini Eye Clinic

Locations

Gemini Eye Clinic

Průhonice, , Czechia

Site Status: RECRUITING

Gemini Eye Clinic

Vyškov, , Czechia

Site Status: COMPLETED

Gemini Eye Clinic

Zlín, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Martin Slovak, PhD

Role: CONTACT

martin.slovak@gemini.cz

+420 730 873 183

Simona Rakusanova, Ing.

Role: CONTACT

simona.rakusanova@gemini.cz

+420 730 873 184

Facility Contacts

Eva Tihelkova, MD

Role: primary

tihelkova@gemini.cz

Martin Slovak, Ph.D.

Role: primary

martin.slovak@gemini.cz

+420730873183

Other Identifiers

OVD PMCF study

Identifier Type: -

Identifier Source: org_study_id