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New lens option may reduce need for glasses after cataract surgery in glaucoma patients

NCT ID NCT07436871

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test whether a special type of lens implant (extended depth-of-focus, or EDOF) can give better vision and more satisfaction than standard monofocal lenses for people with both glaucoma and cataracts. About 74 adults with early-to-moderate open-angle glaucoma will receive the same type of lens in both eyes during cataract surgery. The main goal is to see if the EDOF lens improves intermediate vision (like computer distance) without causing more visual disturbances.

What this could mean

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

Active substance
Extended depth-of-focus (EDOF) intraocular lens
What this could lead to
If successful, this could show that EDOF lenses are a safe option for glaucoma patients, offering better intermediate vision and less need for glasses after cataract surgery.
What could go wrong
This is a small, early-stage trial (74 people) that hasn't started yet. Results may not apply to all glaucoma patients, and EDOF lenses might cause more glare or halos than monofocal lenses.

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

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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: * Patients of any sex aged 18 years or older willing to participate and sign the informed consent form. * Clinically significant cataracts in both eyes. * Patients clinically diagnosed of primary open angle glaucoma (POAG) in both eyes. * Early to moderate POAG, as defined by a mean deviation in the Humphrey Visual Field Analyzer (HFA) no worse than ≤ -12 dB and worse ≥ -2 dB at least in one eye, using a 24-2 SITA standard strategy * Two visual field tests without progression and stability of RNFL in Optical Coherence Tomography (OCT) thickness remaining same or less than 10 um in the previous 6 months, with pharmacologically controlled IOP in both eyes \<21mmHg. * Potential for post-surgery monocular distance corrected visual acuity of ≤ 0.10 LogMAR. * Normal corneal topography. * Able to attend all study visits. Exclusion criteria: * Patients with uncontrolled glaucoma, defined as those with an IOP ≥21 mm Hg despite maximal medical therapy, requiring glaucoma surgery and/or laser in either eye in the next year. * Pre-surgery refractive error requiring IOL implantation beyond the commercially available range. * Patients with a not reliable visual field, a VFI ≤ 60% or defects of ≤ 10 dB in the 4 central points of the visual field. Any other form of glaucoma (pseudoexfoliative, severe forms of pigmentary, primary angle closure glaucoma, etc.), ocular hypertension, zonular instability or possible intuitive lens decentration after surgery. * Patients with any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months. * Any other ocular pathology that can affect the results. * Use of topic or systemic medication that may affect vision * Unable to cooperate to obtain consistent testing results. * Participation in any other trial during or within 30 days of the screening visit.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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