Accuracy of Intra Ocular Lens CARLEVALE Calculation | NCT05368870

Studies
Accuracy of Intra Ocular Lens CARLEVALE Calculation

NCT05368870

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jan 19, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Lens Diseases

Interventions

Carlevale implantation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

Jun 1, 2022Actual

First Submitted Date

Apr 10, 2022

First Submission Date that Met QC Criteria

May 6, 2022

First Posted Date

May 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2024

Last Update Posted Date

Jan 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Retrospective comparison of refractive spherical equivalent predicted before surgery and measured after surgery in patient who underwent implantation of an sutureless scleral fixation posterior chamber intra ocular lens between October 2019 and Avril 2022 in the ophthalmology department of Poitiers Hospital and La Rochelle Hospital.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carlevale implantation			Procedure: Carlevale implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carlevale implantation	Procedure	Vitrectomy and Carlevale implantation	Carlevale implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier universitaire		Poitiers	Vienne	86000	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Refractive data

Types

Study Protocol

Time Frame

6 months after publication

Access Criteria

Not provided

URL

Not provided