CompletedNot Applicable

The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study

United States176 participantsStarted 2019-10-11

Plain-language summary

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment parameters with the ANTERION

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 22 years or older
. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
. Able to fixate
. With the following eye pathology status for the individual eye population:

Exclusion criteria

. Subjects which were enrolled in the B-2018-1 clinical study
. Active infection or inflammation in the study eye
. Insufficient tear film or corneal reflex
. Physical inability to be properly positioned at the study devices or eye exam equipment
. Rigid contact lens wear 2 weeks prior to imaging
. Soft lenses worn within one hour prior to imaging
. With the following eye pathology status for the individual eye population:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Precision and Agreement 1

Timeframe: 1 day

Precision and Agreement 2

Timeframe: 1 day

Precision and Agreement 3

Timeframe: 1 day

Precision and Agreement 4

Timeframe: 1 day

Precision and Agreement 5

Timeframe: 1 day

Precision and Agreement 6

Timeframe: 1 day

Precision and Agreement 7

Timeframe: 1 day

Trial details

NCT IDNCT04130490

SponsorHeidelberg Engineering GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-30

View on ClinicalTrials.gov More Cataract trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 22 years or older
. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
. Able to fixate
. With the following eye pathology status for the individual eye population:

Exclusion criteria

. Subjects which were enrolled in the B-2018-1 clinical study
. Active infection or inflammation in the study eye
. Insufficient tear film or corneal reflex
. Physical inability to be properly positioned at the study devices or eye exam equipment
. Rigid contact lens wear 2 weeks prior to imaging
. Soft lenses worn within one hour prior to imaging
. With the following eye pathology status for the individual eye population: