Bilateral CataractNCT05832749
Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD
An observational study of Bilateral Cataract and Unilateral Cataract, run by Gemini Eye Clinic at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bilateral Cataract, Unilateral Cataract
- What is being tested?
- Ophtesis Bio 3% ophthalmic viscosurgical device and Healon Endocoat 3% ophthalmic viscosurgical device
- Type of treatment
- Medical device
- How many people
- 296 participants
- Where
- 3 sitesCzechia
- Study dates
- 23 Aug 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites, 2 recruiting
- Recruiting
Gemini Eye Clinic
Průhonice, 252 43
Eva Tihelkova, MD, tihelkova@gemini.cz
Eva Tihelkova, MD
- Completed
Gemini Eye Clinic
Vyškov, 682 01
- Recruiting
Gemini Eye Clinic
Zlín, 76001
Martin Slovak, Ph.D., +420730873183, martin.slovak@gemini.cz
Pavel Stodulka, MD
About this study
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)
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.
Read the 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.
- Conditions
- Bilateral Cataract, Unilateral Cataract
- Being tested
- Ophtesis Bio 3% ophthalmic viscosurgical device, Healon Endocoat 3% ophthalmic viscosurgical device
- Keywords
- cataract, eye surgery, ovd, ophtesis bio, sodium hyaluronate
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophtesis Bio 3% ophthalmic viscosurgical deviceDevice
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.
Healon Endocoat 3% ophthalmic viscosurgical deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Product: Ophtesis Bio 3% | Subjects to receive Ophtesis Bio 3% in one eye Receives: Device: Ophtesis Bio 3% ophthalmic viscosurgical device | |
| Control Product: Healon Endocoat 3% | Subjects to receive Healon Endocoat 3% in one eye Receives: Device: Healon Endocoat 3% ophthalmic viscosurgical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater
Measured: 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
Measured: first day
Secondary outcomes (5)
Biomicroscopic Slit-Lamp Exam
Rate of inflammation
Measured: Pre-operative visit, 7 days
IOP change
IOP change from Pre-operative visit at the 7-day postoperative visit
Measured: 7 days
IOP change
IOP change from Pre-operative to up to 1 hour post op
Measured: first day
Dilated fundus exam
Examination to help assess ocular health
Measured: Pre-operative visit, after only if medically indicated
Serious and /or Device-Related Adverse Events
Rates of serious and/or device-related adverse events
Measured: first day, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start23 Aug 2022
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Pavel Stodulka, Gemini Eye Clinic
- Investigators
- Pavel Stodulka, MD, Principal investigator, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832749
- Sponsor's protocol ID
- OVD PMCF study
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05832749
- Acronym / sponsor ID
- OVD PMCF study
- Conditions
- Bilateral Cataract, Unilateral Cataract
- Keywords
- cataract, eye surgery, ovd, ophtesis bio, sodium hyaluronate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Gemini Eye ClinicIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Product: Ophtesis Bio 3% | – | Device: Ophtesis Bio 3% ophthalmic viscosurgical deviceSubjects to receive Ophtesis Bio 3% in one eye |
| Control Product: Healon Endocoat 3% | – | Device: Healon Endocoat 3% ophthalmic viscosurgical deviceSubjects to receive Healon Endocoat 3% in one eye |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophtesis Bio 3% ophthalmic viscosurgical deviceIntraocular 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. | Device | Study Product: Ophtesis Bio 3% |
| Healon Endocoat 3% ophthalmic viscosurgical deviceHealon@ 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. | Device | Control Product: Healon Endocoat 3% |
Primary outcome
Intraocular pressure (IOP)
Time frame: 7 days
Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater
Surgeon questionnaire
Time frame: 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
5 secondary outcomes
Biomicroscopic Slit-Lamp Exam
Time frame: Pre-operative visit, 7 days
IOP change
Time frame: 7 days
IOP change
Time frame: first day
Dilated fundus exam
Time frame: Pre-operative visit, after only if medically indicated
Serious and /or Device-Related Adverse Events
Time frame: first day, 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Stodulka, MD principal investigator
Gemini Eye Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Cataract and Unilateral Cataract, run by Gemini Eye Clinic at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Slovak, PhD (+420 730 873 183, martin.slovak@gemini.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.