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)

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.

Study Overview

• Status: Recruiting
• Conditions: Bilateral Cataract; Unilateral Cataract
• Intervention / Treatment: Device: Ophtesis Bio 3% ophthalmic viscosurgical device; Device: Healon Endocoat 3% ophthalmic viscosurgical device

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.

• Study Type: Observational
• Enrollment (Anticipated): 296

Contacts and Locations

• Study Contact: Name: Martin Slovak, PhD; Phone Number: +420 730 873 183; Email: martin.slovak@gemini.cz
• Study Contact Backup: Name: Simona Rakusanova, Ing.; Phone Number: +420 730 873 184; Email: simona.rakusanova@gemini.cz

Study Locations

• Czechia
  • Průhonice, Czechia, 252 43
    • Recruiting
    • Gemini Eye Clinic
    • Contact: Eva Tihelkova, MD; Email: tihelkova@gemini.cz
    • Principal Investigator: Eva Tihelkova, MD
  • Vyškov, Czechia, 682 01
    • Completed
    • Gemini Eye Clinic
  • Zlín, Czechia, 76001
    • Recruiting
    • Gemini Eye Clinic
    • Principal Investigator: Pavel Stodulka, MD
    • Contact: Martin Slovak, Ph.D.; Phone Number: +420730873183; Email: martin.slovak@gemini.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Product: Ophtesis Bio 3%; Subjects to receive Ophtesis Bio 3% in one eye	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.
Control Product: Healon Endocoat 3%; Subjects to receive Healon Endocoat 3% in one eye	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP)	Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater	7 days
Surgeon questionnaire	The rate of user acceptance ten questions that can be answered on a scale from 1 to 5, 1 means the worst, 5 the best	first day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomicroscopic Slit-Lamp Exam	Rate of inflammation	Pre-operative visit, 7 days
IOP change	IOP change from Pre-operative visit at the 7-day postoperative visit	7 days
IOP change	IOP change from Pre-operative to up to 1 hour post op	first day
Dilated fundus exam	Examination to help assess ocular health	Pre-operative visit, after only if medically indicated
Serious and /or Device-Related Adverse Events	Rates of serious and/or device-related adverse events	first day, 7 days

Collaborators and Investigators

• Sponsor: Gemini Eye Clinic
• Investigators: Principal Investigator: Pavel Stodulka, MD, Gemini Eye Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cataract; sodium hyaluronate; eye surgery; ovd; ophtesis bio
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: OVD PMCF study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No