An observational study in Bilateral Cataract and Unilateral Cataract, sponsored by Gemini Eye Clinic. Status unknown at 3 sites in Czechia. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Gemini Eye Clinic · Observational
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.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 296 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Gemini Eye Clinic is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects to receive Ophtesis Bio 3% in one eye
Device: Ophtesis Bio 3% ophthalmic viscosurgical device
Subjects to receive Healon Endocoat 3% in one eye
Device: Healon Endocoat 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.
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.
Intraocular pressure (IOP)
Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater
Time frame: 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
Time frame: first day
Biomicroscopic Slit-Lamp Exam
Rate of inflammation
Time frame: Pre-operative visit, 7 days
IOP change
IOP change from Pre-operative visit at the 7-day postoperative visit
Time frame: 7 days
IOP change
IOP change from Pre-operative to up to 1 hour post op
Time frame: first day
Dilated fundus exam
Examination to help assess ocular health
Time frame: Pre-operative visit, after only if medically indicated
Serious and /or Device-Related Adverse Events
Rates of serious and/or device-related adverse events
Time frame: first day, 7 days
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Apr 2023, 8 months after the start.
Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 8 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Gemini Eye Clinic