Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat. (NCT04702802) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.
Mexico36 participantsStarted 2021-09-07
Plain-language summary
Pilot, controlled, parallel group, open, randomized clinical trial to evaluate the safety of the viscoelastic substance PRO-149 (sodium hyaluronate 3%) after trans-surgical administration as a device in performing phacoemulsification and intraocular lens implantation in 36 patients with age-related cataract, compared to Healon® EndoCoat (sodium hyaluronate 3%).
Who can participate
Age range
49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 49 years old
* Age-related cataract diagnosis which requires phacoemulsification and monofocal intraocular lens implantation
* Being capable of voluntarily grant a signed informed consent.
* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
* Willingness to be subjected to phacoemulsification and monofocal intraocular lens implantation.
* An anterior chamber depth of ≥ 2.8 mm measured through IOL Master®.
* Pre-surgical cardiologic evaluation that validates the patient's eligibility to surgical procedure, including supporting studies: blood biometry, blood chemistry, clotting time, and electrocardiogram. This evaluation must not exceed 45 days prior to the date of signing of the informed consent.
Exclusion Criteria:
* Previous history of any systemic medical affliction that prevents a patient from being considered eligible for the surgical procedure under sedation and topical anesthesia.
* Previous history of Diabetes Mellitus with A1C ≥ 6.5% (48 mmol/mol) or glucose levels (after no caloric ingestion for ≥ 8 hours) of ≥ 126 mg/dL (7.0 mmol/L).
* Poorly controlled systemic arterial hypertension, defined as a value ≥ 140/90 despite the use of three antihypertensive drugs (one of them a diuretic) at maximum dose.
* Previous history of ocular diseases that may limit the BCVA, or that may reactivate or worsen due to the surgical procedure or due to the use of …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.