Near Vision, Refractive Error Correction
Conditions
Brief 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.
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
OTHERDevice
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.
Sponsors
Perfect Lens, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Participant has undergone cataract surgery with an implantation of mono focal IOL. 3. Participant has no significant residual visual issues which the Investigator believes would make the patient ill-suited for the treatment. 4. Vision must be clinically stable in the Investigator's judgment. 5. 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). 1. Participant has a mono focal intraocular lens implanted in both eyes. 2. Both eyes have uncorrected distance visual acuity (UDVA) of 20/40 (0.3 logMAR) or better at 4 meters. 3. 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). 1. Participant has a mono focal intraocular lens implanted in one or both eyes. 2. The eye to be treated requires an adjustment of at least 1.0 D in sphere or cylinder. 3. Difference between UDVA and CDVA pre-treatment is at least 2 lines i.e. 0.2 logMAR.
Exclusion criteria
1. Participants not able to complete the informed consent form. 2. 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. 3. Previous corneal surgery. 4. 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). 5. 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. 6. Amblyopia. 7. 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). 8. Optic nerve atrophy. 9. Iris neovascularization. 10. Participants with diagnosed degenerative eye disorders (e.g., macular degeneration or other retinal disorders). 11. Uncontrolled glaucoma. 12. Any participant currently participating in any other investigational drug or device studies. 13. 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. 14. 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. 15. Any participant disqualified by the Principal Investigator or Medical Monitor for any ocular issue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (common for both cohorts) | 1 month post-treatment to the baseline visit. | 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). |
| Efficacy for Cohort 1 - Addition of Near Vision | Between pre-treatment and 1 month post-treatment. | 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. |
| Efficacy for Cohort 2 - Correction of Refractive Error | Between pre-treatment and 1 month post-treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Near Visual Acuity (UNVA) (key in Cohort 1) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | 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. |
| Distance Corrected Near Visual Acuity (DCNVA) (key in Cohort 1) | 1 week, 1 month and 3 months post-treatment. | 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. |
| Uncorrected Intermediate Visual Acuity (UIVA) (key in Cohort 1) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | 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. |
| Distance Corrected Intermediate Visual Acuity (DCIVA) (key in Cohort 1) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | 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. |
| Subjective Refraction (key in Cohort 2) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | 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. |
| Uncorrected Distance Visual Acuity (UDVA) (key in Cohort 2) | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. | 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. |
| Corrected Distance Visual Acuity (CDVA) | 1 week, 1 month and 3 months post-treatment. | Monocular and binocular CDVA for all post-treatment visits. Percentage of eyes with CDVA worse than 20/40 (0.3 logMAR). |
Countries
Czechia
Contacts
CONTACTSteven Smathers, JD
CONTACTRuth Sahler, PhD
PRINCIPAL_INVESTIGATORPavel Stodulka, PhD FEBOS-CR
Gemini Eye Center
Outcome results
None listed