Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract (BIO-CAT-DENSA)

September 1, 2023 updated by: OFTALVIST (Oftalmología Vistahermosa S.L)

Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract: Benefit of Use of the Enhance Retina Visualization Mode

To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Oftalmología Vistahermosa SL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with dense cataracts.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the correlation of success rate and Dysfunctional Lens Index (DLI, iTrace)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OFTALVIST (Oftalmología Vistahermosa S.L)

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Pedro Tañá, Dr., Oftalmología Vistahermosa SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-CAT-DENSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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