NCT05239715

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

February 3, 2022

Last Update Submit

September 1, 2023

Conditions

Optical Biometer, Cataracts

Keywords

optical biometer, cataracts

Outcome Measures

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

    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 Outcomes (1)

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

    6 months

Interventions

Ocular biometryDIAGNOSTIC_TEST

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dense cataracts.

You may qualify if:

  • LOCS III cataract classification with a grade of ≥3 for nuclear, cortical or posterior subcapsular.
  • DLI index, from the ITrace device, should be ≤ 5.

You may not qualify if:

  • Previous continuous contact lens wear
  • Ocular trauma
  • Intraocular lens surgery
  • Poor fixation
  • Corneal disease (i.e. keratoconus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oftalmología Vistahermosa SL

Alicante, Spain

Location

Related Publications (1)

  • Tana-Rivero P, Aguilar-Corcoles S, Tana-Sanz P, Tana-Sanz S, Montes-Mico R. Axial length acquisition success rates and agreement of four optical biometers and one ultrasound biometer in eyes with dense cataracts. Eye Vis (Lond). 2023 Sep 1;10(1):35. doi: 10.1186/s40662-023-00352-3.

    PMID: 37653460RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Pedro Tañá, Dr.

    Oftalmología Vistahermosa SL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 15, 2022

Study Start

February 10, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)