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

Gemini Eye Clinic

Status

Enrolling

Conditions

Unilateral Cataract

Bilateral Cataract

Treatments

Device: Healon Endocoat 3% ophthalmic viscosurgical device

Device: Ophtesis Bio 3% ophthalmic viscosurgical device

Study type

Observational

Funder types

Industry

Identifiers

NCT05832749

OVD PMCF study

Details and patient eligibility

About

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.

Full 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.

Enrollment

296 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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