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

Assessment of Clinical and Refractive Outcomes of the Use of a Femtosecond Laser to Create Near Vision or Correct Refractive Error in a Patient With Implanted Monofocal IOLs

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Near Vision; Refractive Error Correction
• Intervention / Treatment: Other: Device

Detailed Description

An investigative device built by Perfect Lens will be used to adjust an implanted intraocular lens (IOL). The device uses a femtosecond laser, a scanner, and an OCT. Each participant either does not have near vision or has refractive error pre-treatment. The primary endpoint for the treatment is to create near vision in the treated eye without sacrificing the existing far vision, or correct refractive error.

The participants will be examined at 7 days, 30 days and 90 days after treatment.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Smathers, JD; Phone Number: 214-676-3371; Email: ss@sowellco.com
• Study Contact Backup: Name: Ruth Sahler, PhD; Phone Number: 949-260-9913; Email: rsahler@perfectlens.com

Study Locations

• Czechia
  • Czech Republic
    • Zlín, Czech Republic, Czechia, 760 01
      • Gemini Eye Clinic
      • Contact: Pavel Stodulka, PhD FEBOS-CR; Phone Number: +420 577 202 202; Email: pavel.stoculka@lasik.cz
      • Contact: Martin Slovak, ME PhD; Email: martin.slovak@gemini.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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. Participant has undergone cataract surgery with an implantation of mono focal IOL.
3. Participant has no significant residual visual issues which the Investigator believes would make the patient ill-suited for the treatment.
4. Vision must be clinically stable in the Investigator's judgment.
5. Each eye has Corrected Distance Visual Acuity (CDVA) of at least 0.2 logMAR (20/32).

Specific inclusion criteria for Cohort 1: Creating near vision (participants must fulfill all criteria to be enrolled in Cohort 1).

1. Participant has a mono focal intraocular lens implanted in both eyes.
2. Both eyes have uncorrected distance visual acuity (UDVA) of 20/40 (0.3 logMAR) or better at 4 meters.
3. Each eye has near vision assessed as Distance Corrected Near Visual Acuity (DCNVA) worse than Jeager 8 and/or ETDRS 0.5 logMAR.

Specific inclusion criteria for Cohort 2: Refractive correction (participants must fulfill all criteria to be enrolled in Cohort 2).

1. Participant has a mono focal intraocular lens implanted in one or both eyes.
2. The eye to be treated requires an adjustment of at least 1.0 D in sphere or cylinder.
3. Difference between UDVA and CDVA pre-treatment is at least 2 lines i.e. 0.2 logMAR.

Exclusion Criteria:

1. Participants 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 participants' 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. Participants with diagnosed degenerative eye disorders (e.g., macular degeneration or other retinal disorders).
11. Uncontrolled glaucoma.
12. Any participant currently participating in any other investigational drug or device studies.
13. 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.
14. 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.
15. Any participant disqualified by the Principal Investigator or Medical Monitor for any ocular issue.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of Perfector laser treatment; Active treatment arm	Other: Device; 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.; Other Names: Perfector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Near Visual Acuity (UNVA) (key in Cohort 1)	Monocular and binocular UNVA distribution at 1 week, 1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular UNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular UNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in UNVA between the pre-treatment and at 3 months post-treatment.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Distance Corrected Near Visual Acuity (DCNVA) (key in Cohort 1)	Monocular and binocular UNVA distribution at 1 week, 1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular DCNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular DCNVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment.	1 week, 1 month and 3 months post-treatment.
Uncorrected Intermediate Visual Acuity (UIVA) (key in Cohort 1)	Monocular and binocular UIVA distribution at 1 week,1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular UIVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular UIVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in UIVA between pre-treatment and at 3 months post-treatment.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Distance Corrected Intermediate Visual Acuity (DCIVA) (key in Cohort 1)	Monocular and binocular UNVA distribution at 1week, 1 month and three months post-treatment. 75% of eyes with post-treatment monocular DCIVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular DCIVA of 20/40 (0.3 logMAR) or better at 3 month post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in DCIVA between pre-treatment and at 3 months post-treatment.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Subjective Refraction (key in Cohort 2)	Predictability plots for attempted versus achieved MRSE including regression analysis distribution of MRSE minus target SE (accuracy plots) including: Percentage of eyes with post-op MRSE within: ±0.50 D, ±1.00 D determination of parameters of stability of MRSE.; Distribution of pre-op and post-op manifest cylinder including percentage of eyes with induced (post-treatment) cylinder >2.00 D, ≤1.00 D, and ≤0.50 D.; Predictability of astigmatism (vector-analysis predictability plots of cylinder including regression analysis).; Cylinder vector analyses plots as well as descriptive statistics on: target induced astigmatism, surgical induced astigmatism, correction index, index of success, angle of error, magnitude of error.; Determination of parameters of stability of cylinder.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Uncorrected Distance Visual Acuity (UDVA) (key in Cohort 2)	Monocular and binocular UDVA distribution at 1 week, 1 month and 3 months post-treatment. 75% of eyes with post-treatment monocular UDVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of participants with post-treatment binocular UDVA of 20/40 (0.3 logMAR line) or better at 3 months post-treatment. 75% of eyes with at least two lines (0.2 logMAR) improvement in UIVA between pre-treatment and at 3 months post treatment.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Corrected Distance Visual Acuity (CDVA)	Monocular and binocular CDVA for all post-treatment visits. Percentage of eyes with CDVA worse than 20/40 (0.3 logMAR).	1 week, 1 month and 3 months post-treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Examination Findings	Descriptive analysis of slit lamp examination parameters as e.g., epithelium, stroma, sclera, lens, anterior chamber, fundus.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Intraocular Pressure	Descriptive analysis of intraocular pressure (in mmHg) at post-treatment visits and change from pre-treatment visit in intraocular pressure (in mmHg).	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Tear Breakup Time (TBUT)	Descriptive analysis of tear breakup in seconds at post-treatment visits and change from pre-treatment visit.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Endothelium Cell Count	Descriptive analysis of endothelium cell count at post-treatment visits and change from pre-treatment visit.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Pupil Diameter	Descriptive analysis of pupil diameter assessed under photopic, mesopic, and scotopic conditions at the pre-treatment and post-treatment visits, and the change from the pre-treatment visit.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Aberrometry	Descriptive analysis of higher-order aberrations (HOA) assessed using iTrace at the pre-treatment and post-treatment visits, and the change in HOA parameters from the pre-treatment visit.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Defocus Curve (Cohort 2 only)	Subjective evaluation of defocus according to ISO 11979-7:2024 under photopic conditions at the pre-treatment and post-treatment visits. Pre-treatment and post-treatment assessments will be performed in both eyes with distance correction.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Contrast Sensitivity	Calculation of the mean and standard deviation of contrast sensitivity for each spatial frequency at the pre-treatment and post-treatment visits, as well as the difference between pre-treatment and post-treatment values. Testing is performed monocularly with distance correction to compensate for the shorter test distance of 2.5 meters, both pre-treatment and post-treatment.	Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Patient-Reported Outcomes Using Questionnaires - Quality of Vision, Treatment Satisfaction, Spectacle Independence, and OSDI Index	Descriptive analysis of participant questionnaires including participant satisfaction following the treatment.	At pre-treatment and at 3 months post-treatment.

Collaborators and Investigators

• Sponsor: Perfect Lens, LLC
• Investigators: Principal Investigator: Pavel Stodulka, PhD FEBOS-CR, Gemini Eye Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Equipment and Supplies
• Other Study ID Numbers: PL-RIS02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification, will be shared.
• IPD Sharing Time Frame: The individual participant data will be shared upon release of the clinical study report, no end date.
• IPD Sharing Access Criteria: Access will be available for analysis for any purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No