Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs

Perfect Lens, LLC

Status: Completed

Conditions: Presbyopia

Treatments: Device: Perfector

Study type: Interventional

Funder types: Industry

Identifiers

NCT07384182

PL-RISO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent;
2. Subject has undergone cataract surgery and has had a monofocal lens implanted in both eyes;
3. Subject has no significant residual visual issues which the Investigator believes would make the patient ill suited for the Treatment.; and
4. Both eyes have CDVA vision of 20/25 or better at 4m.

Exclusion criteria

1. Subjects not able to complete the informed consent form;
2. Clinically significant corneal abnormalities including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion;
3. Previous corneal surgery;
4. Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the subjects' participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
5. History of or current retinal conditions or predisposition to retinal conditions including retinal detachment, diabetic retinopathy, age related macular degeneration which are assessed to by investigator to confound outcomes;
6. Amblyopia;
7. History of or current anterior or posterior segment inflammation of any etiology, or any disease-producing an inflammatory reaction in the eye (e.g., iritis or uveitis);
8. Optic nerve atrophy;
9. Iris neovascularization;
10. Subjects with diagnosed degenerative eye disorders (e.g., macular degeneration or other retinal disorders);
11. Uncontrolled glaucoma;
12. Any subject currently participating in another investigational drug or device studies; and
13. Any subject disqualified by the Principal Investigator or Medical Monitor for any ocular issue.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Application of Perfector laser treatment

Experimental group

Description:

Active treatment arm

Treatment:

Device: Perfector