Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05458661
Other study ID # B2101CI
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2022
Est. completion date March 2023

Study information

Verified date July 2022
Source Carl Zeiss Meditec AG
Contact Monika Peter, M.Sc.
Phone +49 3641 22016
Email monika.peter@zeiss.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

Device:
Clinical Prototype BioBase (SN 07 and SN 08)
Scheimpflug- or OCT based corneal tomographers with the ability to measure anterior and posterior corneal curvature maps >6mm diameter and corneal pachymetry maps >6mm.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Carl Zeiss Meditec AG

Outcome

Type Measure Description Time frame Safety issue
Primary Data collection for algorithm development - Cornea to retina Scan - Cornea to retina Scan (all axial measurements) The data will be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day 1
Primary Data collection for algorithm development - Corneal topography - Corneal topography (raw data and images) including keratometry The data will then be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day 1
Primary Data collection for algorithm development - - Anterior-segment OCT data - Anterior-segment OCT data The data will be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day 1
Primary Data collection for algorithm development - Extended retina-scan - Extended retina-scan The data will be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day1
Primary Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images) - Reference pictures for markerless alignment of toric IOL (sclera images) The data will be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day 1
Primary Data collection for algorithm development - White-to-white determination - White-to-white determination The data will then be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day 1
Primary Data collection for algorithm development - IOL Imaging pictures - IOL Imaging pictures The data will then be used within the Carl Zeiss Meditec R&D department to further develop the algorithm of this device to get a next generation biometry device with automated base. day 1
Primary Affected measurements - OCT measurements It will be investigated, whether the measurements with the study prototype device are affected by the base movement.
- OCT measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices.
Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
day 1
Primary Affected measurements - Keratometry and Topography measurements It will be investigated, whether the measurements with the study prototype device are affected by the base movement.
- Keratometry and Topography measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices.
Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
day 1
Primary Affected measurements - - WTW measurements It will be investigated, whether the measurements with the study prototype device are affected by the base movement.
- WTW measurements This outcome will be investigated by comparing the raw data of the study prototype device with the data measured with the marketed IOLMaster 700 and Pentacam / MS-39 devices.
Non-optimal positioning and movement could possibly cause blurred images that would prevent a detailed analysis
day 1
See also
  Status Clinical Trial Phase
Completed NCT04685538 - Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. Phase 3
Recruiting NCT06060041 - IC-8 Apthera IOL New Enrollment Post Approval Study
Recruiting NCT05518539 - Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Recruiting NCT05271942 - Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods N/A
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT03751033 - Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings N/A
Completed NCT02529488 - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00 N/A
Completed NCT04539548 - A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract Phase 3
Completed NCT03740659 - Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery Phase 2
Completed NCT03494257 - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification N/A
Completed NCT05119127 - Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome. N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT03739528 - Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery Phase 3
Completed NCT02888210 - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery Phase 3
Completed NCT03356847 - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery N/A
Completed NCT04332640 - Clinical Evaluation of the Next Generation Phaco System N/A
Recruiting NCT03638726 - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification Phase 4
Completed NCT03050697 - Evaluation of the Safety and Performance of the HARMONI® Toric Lens N/A