Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs

NCT07384182 | Completed

• 1 other identifier: PL-RISO1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (3)

• Distance corrected near visual acuity (DCNVA) at 40 cm

  Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 40 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. The hypothesis tested for is to demonstrate superiority of the near vision of treated IOL to the IOL pre-treatment.

  1 month after treatment

• Distance corrected intermediate visual acuity (DCIVA) at 66 cm

  Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 66 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. The hypothesis tested for is to demonstrate non-inferiority of the treated IOL to the pre-treated IOL (using a non-inferiority margin of 0.10 logMAR).

  1 month after treatment

• Corrected distance visual acuity (CDVA) at 4 m

  Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction adjusted for infinity and stand Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 4 meters (m) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. The hypothesis tested for the co-primary effectiveness endpoint is to demonstrate non-inferiority of the treated IOL to the pre-treatment IOL (using a non-inferiority margin of 0.10 logMAR).

  1 month after treatment

Secondary Outcomes (15)

• Uncorrected distance visual acuity (UDVA)

  1 week, 1month and 3 months after treatment

• Uncorrected intermediate visual acuity at 66 cm (UIVA)

  1 week, 1month and 3 months after treatment

• Uncorrected near visual acuity at 40 cm (UNVA)

  1 week, 1month and 3 months after treatment

• Corrected near visual acuity at 40 cm (CNVA)

  1 week, 1month and 3 months after treatment

• Defocus curve

  1month and 3 months after treatment

Study Arms (1)

Application of Perfector laser treatment

EXPERIMENTAL

Active treatment arm

Device: Perfector

Interventions

Perfector DEVICE

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.

Application of Perfector laser treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Subject has undergone cataract surgery and has had a monofocal lens implanted in both eyes;
• Subject has no significant residual visual issues which the Investigator believes would make the patient ill suited for the Treatment.; and
• Both eyes have CDVA vision of 20/25 or better at 4m.

You may not qualify if:

• Subjects not able to complete the informed consent form;
• 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;
• Previous corneal surgery;
• 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);
• 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;
• Amblyopia;
• 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);
• Optic nerve atrophy;
• Iris neovascularization;
• Subjects with diagnosed degenerative eye disorders (e.g., macular degeneration or other retinal disorders);
• Uncontrolled glaucoma;
• Any subject currently participating in another investigational drug or device studies; and
• Any subject disqualified by the Principal Investigator or Medical Monitor for any ocular issue.

Sponsors & Collaborators

• Perfect Lens, LLC: lead

Study Sites (1)

Gemini Eye Clinic

Zlín, Czech Republic, 760 01, Czechia

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pavel Stodulka, PhD FEBOS-CR

  Gemini Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 3, 2026
• Study Start: October 15, 2023
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The individual participant data will be shared upon release of the Clinical Study Report. No end date.
• Access Criteria: Access will be available for analysis for any purpose.

Locations

CZ (1)