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

NCT05832749 | Unknown DMC

• 1 other identifier: OVD PMCF study
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 3

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.

Conditions

Bilateral Cataract; Unilateral Cataract

Keywords

cataract; eye surgery; ovd; ophtesis bio; sodium hyaluronate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Biomicroscopic Slit-Lamp Exam

  Pre-operative visit, 7 days

• IOP change

  7 days

• IOP change

  first day

• Dilated fundus exam

  Pre-operative visit, after only if medically indicated

• Serious and /or Device-Related Adverse Events

  first day, 7 days

Study Arms (2)

Study Product: Ophtesis Bio 3%

Subjects to receive Ophtesis Bio 3% in one eye

Device: Ophtesis Bio 3% ophthalmic viscosurgical device

Control Product: Healon Endocoat 3%

Subjects to receive Healon Endocoat 3% in one eye

Device: Healon Endocoat 3% ophthalmic viscosurgical device

Interventions

Ophtesis Bio 3% ophthalmic viscosurgical device 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.

Study Product: Ophtesis Bio 3%

Healon Endocoat 3% ophthalmic viscosurgical device 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.

Control Product: Healon Endocoat 3%

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gemini Eye Clinic: lead

Study Sites (3)

Gemini Eye Clinic

Průhonice, 252 43, Czechia

RECRUITING

Gemini Eye Clinic

Vyškov, 682 01, Czechia

COMPLETED

Gemini Eye Clinic

Zlín, 76001, Czechia

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Pavel Stodulka, MD

  Gemini Eye Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Slovak, PhD

CONTACT

+420 730 873 183; martin.slovak@gemini.cz

Simona Rakusanova, Ing.

CONTACT

+420 730 873 184; simona.rakusanova@gemini.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief eye surgeon

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 27, 2023
• Study Start: August 23, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)