New eye gel passes safety test in cataract surgery trial
NCT ID NCT04702802
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new gel called PRO-149 used during cataract surgery to protect the eye. 36 adults with age-related cataracts received either the new gel or a standard gel during their operation. The main goal was to check safety by measuring changes in eye cell count and pressure after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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36 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Oct 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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49 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 topical steroids (por example, retinal detachment, macular degeneration, degenerative myopia, proliferative diabetic retinopathy, diabetic macular edema, optic neuritis, uveitis or any other kind of ocular inflammation, glaucoma, intraocular hypertension, corneal dystrophies or ectasias, history of ocular herpes or zoster). * Active ocular infection * Pseudoexfoliation syndrome in the eye to withstand surgery, or any other such zonular compromise. * Pharmacological mydriasis \< 6 mm. * Any congenital anomalies in the eye to withstand surgery. * Any alteration that prevents a reliable Goldmann tonometry in the eye to withstand surgery. * IOP \>21mmHg in the eye to withstand surgery, or previous history of IOP \> 21 mmHg after topical steroid use. * Corneal endothelial cell count \< 1500 cells/mm2 in the eye to withstand surgery. * Previous history of corneal or intraocular surgery. * Planned multiple procedures during cataract surgery (for example, trabeculectomy, keratotomies, etc) * Previous history of ocular trauma in the eye to withstand surgery (including surgical procedures) * Having one functional eye. * Having participated in clinical trials within 30 days prior to signing this study's informed consent form. * Having participated previously in this study. * Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form. * Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date. * Having any kind of programed surgery during the period of this study. * Being or having any immediate family members (spouse, parent/legal tutor, sibling or child) who work either in the investigation center or for the sponsor of this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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SalaUno Salud, S.A.P.I. de C.V.
Mexico City, Mexico
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which lens implant delivers sharper sight after cataract surgery?
- Seeing inside the eye during surgery: a new imaging tool could sharpen lens disease care
- Can Mix-and-Match lenses improve vision after cataract surgery?
- Can AI and a new eye scanner make cataract surgery results more predictable?
- Blue dye under the microscope: could a routine cataract tool damage corneal cells?