NCT07384182

Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs

Assessment of Clinical and Refractive Outcomes of the Use of a Femtosecond to Treat the Symptoms of Presbyopia in a Patient With Implanted Mono Focal IOLs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Perfect Lens, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study aimed to assess the safety and efficacy of treating presbyopia in eyes implanted with a mono focal IOL using a low-energy femtosecond laser.

Detailed description

An investigative device built by Perfect Lens was used to adjust an implanted IOL in 38 eyes. The device uses a femtosecond laser, a scanner, and an OCT. Each patient was presbyopic pre-treatment. The primary endpoint for the treatment was to create near vision in the treated eye without sacrificing the existing far vision. The first patient was treated in October 2023 and the last patient was treated in July 2024. The last patient visit was in November 2024. The patients were examined at 7 days, 30 days and 90 days after treatment.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Perfector	The Perfector is used in the procedure. The Device is attached to the patient by the use of a patient attachment. The patient attachment attaches to the sclera of the eye using vacuum pressure.

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2026-02-03
• Last updated: 2026-02-05

Locations

1 site across 1 country: Czechia