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Not yet recruiting NCT07447622

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

No phase Interventional Near Vision Refractive Error Correction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Device.
Who it may be relevant to
Registry conditions: Near Vision, Refractive Error Correction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Safety (common for both cohorts) [Time frame: 1 month post-treatment to the baseline visit.]
  • Efficacy for Cohort 1 - Addition of Near Vision [Time frame: Between pre-treatment and 1 month post-treatment.]
  • Efficacy for Cohort 2 - Correction of Refractive Error [Time frame: Between pre-treatment and 1 month post-treatment.]
Secondary outcome measures (7)
  • Uncorrected Near Visual Acuity (UNVA) (key in Cohort 1) [Time frame: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
  • Distance Corrected Near Visual Acuity (DCNVA) (key in Cohort 1) [Time frame: 1 week, 1 month and 3 months post-treatment.]
  • Uncorrected Intermediate Visual Acuity (UIVA) (key in Cohort 1) [Time frame: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
  • Distance Corrected Intermediate Visual Acuity (DCIVA) (key in Cohort 1) [Time frame: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
  • Subjective Refraction (key in Cohort 2) [Time frame: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
  • Uncorrected Distance Visual Acuity (UDVA) (key in Cohort 2) [Time frame: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
  • Corrected Distance Visual Acuity (CDVA) [Time frame: 1 week, 1 month and 3 months post-treatment.]

Eligibility criteria

Inclusion criteria

  • 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).

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Gemini Eye Clinic — Zlín

Identifiers

NCT: NCT07447622 · PL-RIS02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗