Cataract Clinical Trial
— BioBaseOfficial title:
Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Carl Zeiss Meditec AG |
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 |
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 |