Near VisionNCT07447622
Clinical Outcomes of the Use of a Femtosecond Laser Treatment in a Patient With Implanted Monofocal IOLs
A study testing Device in people with Near Vision and Refractive Error Correction, run by Perfect Lens, LLC at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Near Vision, Refractive Error Correction
- What is being tested?
- Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2026to Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
- Specific inclusion criteria for Cohort 1: Creating near vision (participants must fulfill all criteria to be enrolled in Cohort 1).
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- 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.
- Specific inclusion criteria for Cohort 2: Refractive correction (participants must fulfill all criteria to be enrolled in Cohort 2).
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Gemini Eye Clinic
Zlín, Czech Republic, 760 01
Pavel Stodulka, PhD FEBOS-CR, +420 577 202 202, pavel.stoculka@lasik.cz
Martin Slovak, ME PhD, martin.slovak@gemini.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Near Vision, Refractive Error Correction
- Being tested
- Device
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceOther
Also called Perfector
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.
| Study group | Role | What they receive |
|---|---|---|
| Application of Perfector laser treatment | Experimental | Active treatment arm Receives: Other: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Between pre-treatment and 1 month post-treatment.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 week, 1 month and 3 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near VisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perfect Lens, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Stodulka, PhD FEBOS-CR, Principal investigator, Gemini Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447622
- Sponsor's protocol ID
- PL-RIS02
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification, will be shared.