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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Safety (common for both cohorts) [Срок оценки: 1 month post-treatment to the baseline visit.]
• Efficacy for Cohort 1 - Addition of Near Vision [Срок оценки: Between pre-treatment and 1 month post-treatment.]
• Efficacy for Cohort 2 - Correction of Refractive Error [Срок оценки: Between pre-treatment and 1 month post-treatment.]

Вторичные конечные точки (7)

• Uncorrected Near Visual Acuity (UNVA) (key in Cohort 1) [Срок оценки: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
• Distance Corrected Near Visual Acuity (DCNVA) (key in Cohort 1) [Срок оценки: 1 week, 1 month and 3 months post-treatment.]
• Uncorrected Intermediate Visual Acuity (UIVA) (key in Cohort 1) [Срок оценки: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
• Distance Corrected Intermediate Visual Acuity (DCIVA) (key in Cohort 1) [Срок оценки: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
• Subjective Refraction (key in Cohort 2) [Срок оценки: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
• Uncorrected Distance Visual Acuity (UDVA) (key in Cohort 2) [Срок оценки: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.]
• Corrected Distance Visual Acuity (CDVA) [Срок оценки: 1 week, 1 month and 3 months post-treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• Gemini Eye Clinic — Zlín

Идентификаторы

NCT: NCT07447622 · PL-RIS02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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