Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of Perfector laser treatment | Experimental | Active treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | Between pre-treatment and 1 month post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Examination Findings | Descriptive analysis of slit lamp examination parameters as e.g., epithelium, stroma, sclera, lens, anterior chamber, fundus. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Intraocular Pressure |
Inclusion Criteria:
Specific inclusion criteria for Cohort 1: Creating near vision (participants must fulfill all criteria to be enrolled in Cohort 1).
Specific inclusion criteria for Cohort 2: Refractive correction (participants must fulfill all criteria to be enrolled in Cohort 2).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Smathers, JD | Contact | 214-676-3371 | ss@sowellco.com | |
| Ruth Sahler, PhD | Contact | 949-260-9913 | rsahler@perfectlens.com |
| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, PhD FEBOS-CR | Gemini Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | Czech Republic | 760 01 | Czechia |
All of the individual participant data collected during the trial, after de-identification, will be shared.
The individual participant data will be shared upon release of the clinical study report, no end date.
Access will be available for analysis for any purpose.
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 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:
| 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. | 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). | 1 week, 1 month and 3 months post-treatment. |
Descriptive analysis of intraocular pressure (in mmHg) at post-treatment visits and change from pre-treatment visit in intraocular pressure (in mmHg).
| Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Tear Breakup Time (TBUT) | Descriptive analysis of tear breakup in seconds at post-treatment visits and change from pre-treatment visit. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Endothelium Cell Count | Descriptive analysis of endothelium cell count at post-treatment visits and change from pre-treatment visit. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Pupil Diameter | Descriptive analysis of pupil diameter assessed under photopic, mesopic, and scotopic conditions at the pre-treatment and post-treatment visits, and the change from the pre-treatment visit. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Aberrometry | Descriptive analysis of higher-order aberrations (HOA) assessed using iTrace at the pre-treatment and post-treatment visits, and the change in HOA parameters from the pre-treatment visit. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Defocus Curve (Cohort 2 only) | Subjective evaluation of defocus according to ISO 11979-7:2024 under photopic conditions at the pre-treatment and post-treatment visits. Pre-treatment and post-treatment assessments will be performed in both eyes with distance correction. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Contrast Sensitivity | Calculation of the mean and standard deviation of contrast sensitivity for each spatial frequency at the pre-treatment and post-treatment visits, as well as the difference between pre-treatment and post-treatment values. Testing is performed monocularly with distance correction to compensate for the shorter test distance of 2.5 meters, both pre-treatment and post-treatment. | Between pre-treatment and 1 week, 1 month and 3 months post-treatment. |
| Patient-Reported Outcomes Using Questionnaires - Quality of Vision, Treatment Satisfaction, Spectacle Independence, and OSDI Index | Descriptive analysis of participant questionnaires including participant satisfaction following the treatment. | At pre-treatment and at 3 months post-treatment. |