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Eye gel showdown: new cataract surgery gel matches old standard

NCT ID NCT05575063

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 gel called Healon EndoCoat, which is used during cataract surgery to protect the eye and keep it stable. Researchers compared a new version of the gel to the current version in 165 people having cataract surgery in both eyes. The goal was to see if the new gel worked just as well at protecting the eye and controlling pressure after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Healon EndoCoat ophthalmic viscosurgical device (a gel used during cataract surgery to protect the eye)
What this could lead to
If successful, this confirms that the new gel works as well as the existing one for protecting the eye during cataract surgery.
What could go wrong
This is a completed study comparing two similar gels, so it's not testing a new treatment. The results may not apply to other surgical gels or procedures.

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

165 people

The number who actually took part.

Started

Nov 2022

Finished

Dec 2023

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

22 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: 1. Minimum 22 years of age 2. Cataracts for which extraction and posterior chamber IOL implantation have been planned in both eyes 3. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better 4. Clear intraocular media, other than cataract 5. Availability, willingness and sufficient cognitive awareness to comply with examination procedures 6. Signed informed consent and HIPAA authorization Exclusion Criteria: 1. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) 2. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject 3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery 4. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study. 5. Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery) 6. Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects 7. Use of systemic or ocular medications that may affect vision or IOP 8. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study, or in the opinion of the investigator, may confound the outcome(s) of the study 9. Poorly-controlled diabetes 10. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). 11. Known steroid responder 12. Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve 13. Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the average of the three cell counts as taken by the Konan Specular Microscope) 14. Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) 15. 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 16. Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

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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

  • Berkeley Eye Institute, P.A.

    Houston, Texas, 77027, United States

  • Empire Eye & Laser Center

    Bakersfield, California, 93309, United States

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704, United States

  • Focal Point Vision

    San Antonio, Texas, 78209, United States

  • Parkhurst NuVision

    San Antonio, Texas, 78229, United States

  • Scott & Christie and Associates

    Cranberry Township, Pennsylvania, 16066, United States

  • Southern California Eye Physicians and Associates

    Long Beach, California, 90805, United States

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502, United States

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