UnknownNot Applicable

Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort

100 participantsStarted 2022-08

Plain-language summary

The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.

Who can participate

Age range

21 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: * Male or female 21 years of age and older * Able and willing to make the required study visit * Able and willing to provide consent and follow study instructions * Patients must have understood and signed the informed consent Exclusion Criteria: * Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement * Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.) * Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF) * Known Pregnancy

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

Data collection for algorithm development - Cornea to retina Scan

Timeframe: day 1

Data collection for algorithm development - Corneal topography

Timeframe: day 1

Data collection for algorithm development - - Anterior-segment OCT data

Timeframe: day 1

Data collection for algorithm development - Extended retina-scan

Timeframe: day1

Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)

Timeframe: day 1

Data collection for algorithm development - White-to-white determination

Timeframe: day 1

Data collection for algorithm development - IOL Imaging pictures

Timeframe: day 1

Trial details

NCT IDNCT05458661

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03

Contact for this trial

Monika Peter, M.Sc.

+49 3641 22016 monika.peter@zeiss.com

View on ClinicalTrials.gov More Cataract trials

Plain-language summary

Who can participate

Age range

21 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.

What they're measuring

Data collection for algorithm development - Cornea to retina Scan

Timeframe: day 1

Data collection for algorithm development - Corneal topography

Timeframe: day 1

Data collection for algorithm development - - Anterior-segment OCT data

Timeframe: day 1

Data collection for algorithm development - Extended retina-scan

Timeframe: day1

Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)

Timeframe: day 1

Data collection for algorithm development - White-to-white determination

Timeframe: day 1

Data collection for algorithm development - IOL Imaging pictures

Timeframe: day 1