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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Gemini Eye Clinic
Zlín, Czech Republic, Czechia
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).
Time frame: 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.
Time frame: 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.
Time frame: Between pre-treatment and 1 month post-treatment.
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.
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)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
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)
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.
Time frame: 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: 1. Percentage of eyes with post-op MRSE within: ±0.50 D, ±1.00 D determination of parameters of stability of MRSE. 2. 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. 3. Predictability of astigmatism (vector-analysis predictability plots of cylinder including regression analysis). 4. 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. 5. Determination of parameters of stability of cylinder.
Time frame: 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.
Time frame: 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).
Time frame: 1 week, 1 month and 3 months post-treatment.