NCT05368870

Brief Summary

The purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new Carlevale sutureless scleral fixation posterior chamber intra ocular lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration 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

Study Start

First participant enrolled

April 1, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

April 10, 2022

Last Update Submit

January 18, 2024

Conditions

Lens Diseases

Outcome Measures

Primary Outcomes (1)

  • Prediction error

    Difference between the measured and predicted post-operative refractive spherical equivalent for the intra oculaire lens power implanted

    Between Month 1 and Month 6

Study Arms (1)

Carlevale implantation

Procedure: Carlevale implantation

Interventions

Carlevale implantationPROCEDURE

Vitrectomy and Carlevale implantation

Carlevale implantation

Eligibility Criteria

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

All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2022 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital

You may qualify if:

  • All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2022 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital

You may not qualify if:

  • Post surgery best corrected visual acuity worse than 20/40
  • Keratoconus
  • Macular oedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire

Poitiers, Vienne, 86000, France

Location

MeSH Terms

Conditions

Lens Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2022

First Posted

May 10, 2022

Study Start

April 1, 2019

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Refractive data

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication

Locations

FR(1)