Aspheric Monofocal Intraocular Lens in Pediatric Patients

Completed

• Conditions: Cataract in Child

• Registration Number: NCT06153745
• Lead Sponsor: Luca Buzzonetti

Brief Summary

To evaluate the performance a new aspheric monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.

Detailed Description

thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the Tecnis Eyhance ICB00 IOL were evaluated. Visual acuity was assessed three months after surgery for distance (CDVA), intermediate (CIVA) and near visual acuity (CNVA).

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• monolateral cataract

Exclusion Criteria

• other ocular diseases
• systemic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corrected Distance Visual Acuity	3 months postoperatively	Decimal
Corrected Intermediate Visual Acuity	3 months postoperatively	Decimal
Corrected Near Visual Acuity	3 months postoperatively	Decimal

Trial Locations

Locations (1)

Luca Buzzonetti; 🇮🇹 Roma, Italy