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New lens implant aims to sharpen vision for cataract patients

NCT ID NCT03844828

Disease control Sponsor: Beaver-Visitec International, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a special lens implant that corrects cataracts, presbyopia (need for reading glasses), and astigmatism (blurry vision from an irregularly shaped cornea). The goal is to see if this lens stays stable in the eye and provides good vision at all distances. About 100 adults aged 45 and older with cataracts or presbyopia and significant astigmatism are taking part. The study compares their results to those from an earlier study on a similar lens.

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 100 people

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

Started

Mar 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

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

45 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: * Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia; * Regular corneal astigmatism ≥0.75 dioptres (measured by an automatic keratometer or biometer) in one or both eyes; * Capability to understand and sign an IRB approved informed consent form and privacy authorization; * Clear intraocular media other than cataract; * Calculated IOL power is within the range of the study IOLs; * Dilated pupil size large enough to visualize IOL axis markings postoperatively; * Willing and able to conform to the study requirements. Exclusion Criteria: * Regular corneal astigmatism \<0.75 dioptres (measured by an automatic keratometer or biometer) in both eyes * Irregular astigmatism; * Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse; * Subjects with AMD suspicious eyes as determined by OCT examination; * Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema; * Previous intraocular or corneal surgery; * Traumatic cataract; * History or presence of macular edema; * Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study; * Concurrent or previous (within 30 days) participation in another drug or device investigation; * Instability of keratometry or biometry measurements; * Ocular hypertension or glaucoma; * Significant dry eye; * Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).

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Conditions

The condition(s) this trial relates to.

cataract presbyopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataract Lens opacities Presbyopia

Contacts and locations

Locations

  • Asian Eye Institute

    Makati City, 1200, Philippines

More trials for these conditions

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