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New eye gel passes safety test in cataract surgery trial

NCT ID NCT04702802

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

36 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 2021

Lead sponsor

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

49 years and older

Sex

Anyone

Healthy volunteers

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

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

  • SalaUno Salud, S.A.P.I. de C.V.

    Mexico City, Mexico

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Other studies related to the condition(s) this trial covers.