Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD
- Conditions
- Unilateral CataractBilateral Cataract
- Interventions
- Device: Ophtesis Bio 3% ophthalmic viscosurgical deviceDevice: Healon Endocoat 3% ophthalmic viscosurgical device
- Registration Number
- NCT05832749
- Lead Sponsor
- Gemini Eye Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 296
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Product: Ophtesis Bio 3% Ophtesis Bio 3% ophthalmic viscosurgical device Subjects to receive Ophtesis Bio 3% in one eye Control Product: Healon Endocoat 3% Healon Endocoat 3% ophthalmic viscosurgical device Subjects to receive Healon Endocoat 3% in one eye
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method IOP change first day IOP change from Pre-operative to up to 1 hour post op
Biomicroscopic Slit-Lamp Exam Pre-operative visit, 7 days Rate of inflammation
Serious and /or Device-Related Adverse Events first day, 7 days Rates of serious and/or device-related adverse events
Dilated fundus exam Pre-operative visit, after only if medically indicated Examination to help assess ocular health
Trial Locations
- Locations (1)
Gemini Eye Clinic
🇨🇿Zlín, Czechia