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

Study Overview
=================
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.

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)

Conditions
-----------------
Bilateral Cataract, Unilateral Cataract

Intervention / Treatment
-----------------
* Device: Ophtesis Bio 3% ophthalmic viscosurgical device
* Device: Healon Endocoat 3% ophthalmic viscosurgical device


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Product: Ophtesis Bio 3%<br>Subjects to receive Ophtesis Bio 3% in one eye | Device: Ophtesis Bio 3% ophthalmic viscosurgical device<br>* 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.<br>|
| Control Product: Healon Endocoat 3%<br>Subjects to receive Healon Endocoat 3% in one eye | Device: Healon Endocoat 3% ophthalmic viscosurgical device<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovd, cataract, eye surgery, ophtesis bio, sodium hyaluronate