Accuracy of Intra Ocular Lens CARLEVALE Calculation

Lens Diseases Clinical Trial

Official title:

Refractive Outcomes After Scleral Fixation of the Carlevale Intraocular Lens: Retrospective Study of Power Calculation Accuracy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368870
• Other study ID #: Observational retrospective
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2024
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lens Diseases

Intervention

Procedure:
• Carlevale implantation
Vitrectomy and Carlevale implantation

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Poitiers	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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