Which lens gives sharper sight after cataract surgery? a Head-to-Head trial

NCT ID NCT07688681

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study compares two types of artificial lenses used during cataract surgery, both designed to provide clear vision at far and intermediate distances. Adults having cataract surgery in both eyes are randomly assigned to receive either the Tecnis PureSee or the 1stQ Comfort Z-EDOF lens. The goal is to see which lens offers a wider range of clear vision and better overall satisfaction, helping doctors and patients make informed choices.

What this could mean

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

Active substance
Tecnis PureSee intraocular lens and 1stQ Comfort Z-EDOF intraocular lens
What this could lead to
If one lens proves better, it could help cataract patients achieve clearer vision at far and intermediate distances with less need for glasses after surgery.
What could go wrong
This is a relatively small study comparing two specific lens designs. Results may not apply to all patients or lens types, and individual outcomes can vary.

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 110 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

40 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 ≥40 years, able to understand the study and give written informed consent * Clinically significant bilateral age-related cataract suitable for phacoemulsification with posterior chamber IOL implantation * Expected postoperative best-corrected visual acuity ≤0.2 logMAR in both eyes * Regular corneal astigmatism ≤4.5 D in both eyes (IOLMaster 700) * Axial length 21.5-26.5 mm in both eyes * Clear cornea without clinically significant opacities, scars, or stromal dystrophies * Normal pupil function; no significant anisocoria (≥1 mm) and no afferent pupillary defect * Acceptance of the target refraction strategy: emmetropia in the dominant eye and -0.50 D in the non-dominant eye * Willing and able to attend all follow-up visits (Month 1, 3, and 6) * Written informed consent obtained before any study-related procedure Exclusion Criteria: * Prior corneal refractive surgery, corneal transplantation, glaucoma filtering surgery, or vitreoretinal surgery in either eye (uncomplicated intravitreal injections allowed) * Irregular astigmatism, keratoconus, forme fruste keratoconus, corneal ectasia, significant corneal opacities or scars, or endothelial dystrophy * Keratometric astigmatism \>4.5 D in either eye * Axial length \<21.5 mm or \>26.5 mm in either eye * Calculated IOL power outside the available range of either study lens * Macular pathology expected to limit visual acuity (e.g., age-related macular degeneration, diabetic maculopathy, epiretinal membrane, macular hole) * Advanced glaucoma with central visual field involvement, or IOP not controlled on ≤2 topical medications * Optic neuropathy expected to limit visual potential * Pre-existing amblyopia in either eye * Significant anisocoria, afferent pupillary defect, non-dilating pupil, or iris abnormalities affecting IOL function or measurement * Endothelial cell density \<1500 cells/mm² * Uncontrolled diabetes mellitus (HbA1c \>9%) or autoimmune disease with active ocular involvement * Systemic medications affecting pupil size that cannot be discontinued (e.g., tamsulosin) * Pregnancy or breastfeeding * Intraoperative complication precluding safe in-the-bag IOL implantation (affected eyes withdrawn) * Cognitive impairment, language barrier, or other factors preventing reliable participation * Current enrollment in another interventional clinical study affecting visual outcomes

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund

    Vienna, State of Vienna, 1130, Austria

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