Clinical trial NCT05832749: Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bilateral Cataract
Unilateral Cataract
Keywords: cataract
eye surgery
ovd
ophtesis bio
sodium hyaluronate
Lead sponsor: Gemini Eye Clinic
Sponsor class: INDUSTRY
First posted: 2023-04-27
Enrollment: 296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 7 days
measure: Surgeon questionnaire
timeFrame: first day
Secondary outcomes:
measure: Biomicroscopic Slit-Lamp Exam
timeFrame: Pre-operative visit, 7 days
measure: IOP change
timeFrame: 7 days
measure: IOP change
timeFrame: first day
measure: Dilated fundus exam
timeFrame: Pre-operative visit, after only if medically indicated
measure: Serious and /or Device-Related Adverse Events
timeFrame: first day, 7 days
Other outcomes:
Locations:
city: Průhonice
country: Czechia
facility: Gemini Eye Clinic
city: Vyškov
country: Czechia
facility: Gemini Eye Clinic
city: Zlín
country: Czechia
facility: Gemini Eye Clinic
Study officials:
affiliation: Gemini Eye Clinic
name: Pavel Stodulka, MD
role: PRINCIPAL_INVESTIGATOR
References: