BIO-CAT-DENSA: Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract
Sponsor
OFTALVIST (Oftalmología Vistahermosa S.L) (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05239715
Collaborator
Alcon Research (Industry)
50
1
5.9
8.4
Study Details
Study Description
Brief Summary
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
Study Design
Study Type:
Observational
Anticipated Enrollment
:
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract: Benefit of Use of the Enhance Retina Visualization Mode
Actual Study Start Date
:
Jan 24, 2022
Anticipated Primary Completion Date
:
Jul 24, 2022
Anticipated Study Completion Date
:
Jul 24, 2022
Outcome Measures
Primary Outcome Measures
- To describe and compare the acquisition rate between different biometers in eyes To describe and compare the acquisition success rate between different biometers in eyes with advanced cataracts [6 months]
Acquision succes rate is indicated by a percentage, from 0% to 100%. The biometer can obtain (success) or not (failure) the measurement. This value will be indicated for each biometer.
Secondary Outcome Measures
- To describe the correlation of success rate and Dysfunctional Lens Index (DLI, iTrace) [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
LOCS III cataract classification with a grade of ≥3 for nuclear, cortical or posterior subcapsular.
-
DLI index, from the ITrace device, should be ≤ 5.
Exclusion Criteria:
-
Previous continuous contact lens wear
-
Ocular trauma
-
Intraocular lens surgery
-
Poor fixation
-
Corneal disease (i.e. keratoconus)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oftalmología Vistahermosa SL | Alicante | Spain |
Sponsors and Collaborators
- OFTALVIST (Oftalmología Vistahermosa S.L)
- Alcon Research
Investigators
- Principal Investigator: Pedro Tañá, Dr., Oftalmología Vistahermosa SL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
OFTALVIST (Oftalmología Vistahermosa S.L)
ClinicalTrials.gov Identifier:
NCT05239715
Other Study ID Numbers:
- BIO-CAT-DENSA
First Posted:
Feb 15, 2022
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by OFTALVIST (Oftalmología Vistahermosa S.L)
Additional relevant MeSH terms: