Accuracy of Intra Ocular Lens CARLEVALE Calculation

Completed

• Conditions: Lens Diseases
• Interventions: Procedure: Carlevale implantation

• Registration Number: NCT05368870
• Lead Sponsor: Poitiers University Hospital

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2022-04-10
• Primary Completion: 2022-05-01
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Study Completion: 2022-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carlevale implantation	Carlevale implantation	-

Primary Outcome Measures

Name	Time	Method
Prediction error	Between Month 1 and Month 6	Difference between the measured and predicted post-operative refractive spherical equivalent for the intra oculaire lens power implanted

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Poitiers, Vienne, France