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

Bilateral Cataract Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832749
• Other study ID #: OVD PMCF study
• Status: Recruiting
• Start date: August 23, 2022
• Est. completion date: May 2023

Study information

• Verified date: April 2023
• Source: Gemini Eye Clinic
• Contact: Martin Slovak, PhD
• Phone: +420 730 873 183
• Email: martin.slovak[@]gemini.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Cataract
• Cataract

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	Gemini Eye Clinic	Pruhonice
Czechia	Gemini Eye Clinic	Vyškov
Czechia	Gemini Eye Clinic	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
Gemini Eye Clinic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP)	Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater	7 days
Primary	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	Biomicroscopic Slit-Lamp Exam	Rate of inflammation	Pre-operative visit, 7 days
Secondary	IOP change	IOP change from Pre-operative visit at the 7-day postoperative visit	7 days
Secondary	IOP change	IOP change from Pre-operative to up to 1 hour post op	first day
Secondary	Dilated fundus exam	Examination to help assess ocular health	Pre-operative visit, after only if medically indicated
Secondary	Serious and /or Device-Related Adverse Events	Rates of serious and/or device-related adverse events	first day, 7 days