Bilateral Cataract, Unilateral Cataract
Conditions
Keywords
cataract, eye surgery, ovd, ophtesis bio, sodium hyaluronate
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.
Interventions
DEVICEOphtesis 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.
DEVICEHealon 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.
Sponsors
Gemini Eye Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) | 7 days | Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater |
| Surgeon questionnaire | first day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomicroscopic Slit-Lamp Exam | Pre-operative visit, 7 days | Rate of inflammation |
| IOP change | 7 days | IOP change from Pre-operative visit at the 7-day postoperative visit |
| Dilated fundus exam | Pre-operative visit, after only if medically indicated | Examination to help assess ocular health |
| Serious and /or Device-Related Adverse Events | first day, 7 days | Rates of serious and/or device-related adverse events |
Countries
Czechia
Contacts
Primary ContactMartin Slovak, PhD
Backup ContactSimona Rakusanova, Ing.
Outcome results
None listed