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OpenTrials
Completed

NCT Number: NCT05239715

Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract

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

Completed

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Key information

Conditions

Optical Biometer, Cataracts Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Oftalmología Vistahermosa SL

Alicante, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ocular biometry

Diagnostic Test

Biometry using swept-source OCT Argos, swept-source OCT IOLMaster 700, swept-source OCT Anterion, PCI Pentacam AXL, OcuScan RxP and Itrace measurement

Primary outcomes

  1. 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.

Secondary outcomes

  1. To describe the correlation of success rate and Dysfunctional Lens Index (DLI, iTrace)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

OFTALVIST (Oftalmología Vistahermosa S.L)

Industry

Collaborators

  • Alcon Research

Registry information

Official study 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

Acronym: BIO-CAT-DENSA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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