Not Yet RecruitingNot Applicable

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

Czechia12 participantsStarted 2026-03

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).
✓. 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.

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.

What they're measuring

Safety (common for both cohorts)

Timeframe: 1 month post-treatment to the baseline visit.

Efficacy for Cohort 1 - Addition of Near Vision

Timeframe: Between pre-treatment and 1 month post-treatment.

Efficacy for Cohort 2 - Correction of Refractive Error

Timeframe: Between pre-treatment and 1 month post-treatment.

Trial details

NCT IDNCT07447622

SponsorPerfect Lens, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Steven Smathers, JD

214-676-3371 ss@sowellco.com

View on ClinicalTrials.gov More Near Vision trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).
✓. 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.

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.

What they're measuring

Safety (common for both cohorts)

Timeframe: 1 month post-treatment to the baseline visit.

Efficacy for Cohort 1 - Addition of Near Vision

Timeframe: Between pre-treatment and 1 month post-treatment.

Efficacy for Cohort 2 - Correction of Refractive Error

Timeframe: Between pre-treatment and 1 month post-treatment.