Clinical Outcomes of the Use of a Femtosecond Laser Treatment in a Patient With Implanted Monofocal IOLs

NCT07447622 | Not Yet Recruiting

• 1 other identifier: PL-RIS02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the safety and efficacy of evaluating near vision or refractive error in eyes implanted with a mono focal intraocular lens (IOL) using a low-energy femtosecond laser.

Conditions

Near Vision; Refractive Error Correction

Outcome Measures

Primary Outcomes (3)

• Safety (common for both cohorts)

  The participant will have no serious device adverse event resulting from the treatment. 5% or less with loss of two lines (0.2 logMAR) or more of Corrected Distance Visual Acuity (CDVA).

  1 month post-treatment to the baseline visit.

• Efficacy for Cohort 1 - Addition of Near Vision

  75% of eyes with at least two lines (0.2 logMAR) improvement in Distance Corrected Near Visual Acuity (DCNVA). Participant is assessed by the ETDRS reading chart for near visual acuity at a comfortable reading distance of 40 cm.

  Between pre-treatment and 1 month post-treatment.

• Efficacy for Cohort 2 - Correction of Refractive Error

  75% of eyes with at least two lines (0.2 logMAR) improvement of Uncorrected Distance Visual Acuity (UDVA). Participant is assessed by the ETDRS chart for distance visual acuity at 4 meters.

  Between pre-treatment and 1 month post-treatment.

Secondary Outcomes (7)

• Uncorrected Near Visual Acuity (UNVA) (key in Cohort 1)

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

• Distance Corrected Near Visual Acuity (DCNVA) (key in Cohort 1)

  1 week, 1 month and 3 months post-treatment.

• Uncorrected Intermediate Visual Acuity (UIVA) (key in Cohort 1)

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

• Distance Corrected Intermediate Visual Acuity (DCIVA) (key in Cohort 1)

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

• Subjective Refraction (key in Cohort 2)

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

Other Outcomes (9)

• Slit Lamp Examination Findings

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

• Intraocular Pressure

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

• Tear Breakup Time (TBUT)

  Between pre-treatment and 1 week, 1 month and 3 months post-treatment.

Study Arms (1)

Application of Perfector laser treatment

EXPERIMENTAL

Active treatment arm

Other: Device

Interventions

Device OTHER

The Perfector is used in the procedure. The device is attached to the participant by the use of a patient attachment. The patient attachment attaches to the sclera of the eye using vacuum pressure.

Also known as: Perfector

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.
• Participant has undergone cataract surgery with an implantation of mono focal IOL.
• Participant has no significant residual visual issues which the Investigator believes would make the patient ill-suited for the treatment.
• Vision must be clinically stable in the Investigator's judgment.
• Each eye has Corrected Distance Visual Acuity (CDVA) of at least 0.2 logMAR (20/32).
• Participant has a mono focal intraocular lens implanted in both eyes.
• Both eyes have uncorrected distance visual acuity (UDVA) of 20/40 (0.3 logMAR) or better at 4 meters.
• Each eye has near vision assessed as Distance Corrected Near Visual Acuity (DCNVA) worse than Jeager 8 and/or ETDRS 0.5 logMAR.
• Participant has a mono focal intraocular lens implanted in one or both eyes.
• The eye to be treated requires an adjustment of at least 1.0 D in sphere or cylinder.
• Difference between UDVA and CDVA pre-treatment is at least 2 lines i.e. 0.2 logMAR.

You may not qualify if:

• Participants 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 participants' 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.
• Participants with diagnosed degenerative eye disorders (e.g., macular degeneration or other retinal disorders).
• Uncontrolled glaucoma.
• Any participant currently participating in any other investigational drug or device studies.
• Participants unable to reliably perform visual acuity testing or defocus curve assessments, including intolerance to trial frame correction or inconsistent test responses, in the opinion of the Investigator.
• Clinically significant posterior capsule opacification (PCO) in the study eye that, in the Investigator's judgment, could affect visual acuity, contrast sensitivity, or confound study outcomes.
• Any participant 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

Myopia

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pavel Stodulka, PhD FEBOS-CR

  Gemini Eye Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Smathers, JD

CONTACT

214-676-3371; ss@sowellco.com

Ruth Sahler, PhD

CONTACT

949-260-9913; rsahler@perfectlens.com

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: February 23, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 3, 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)