Investigation of the Safety and Effectiveness of a Trifocal IOL

The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.

• FINEVISION HP IOL (Device): Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
• Alcon AcrySof SN60AT (Device): Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.

Primary outcomes

• Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes [150-180 days after surgery on the first eyes]: Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts on a CTS (Clinical Trial Suite, M\&S Technologies) device at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower or negative value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate non-inferiority of FINEVISION HP trifocal IOL to the control IOL in mean photopic monocular logMAR BCDVA (best corrected distance visual acuity) for the first operative eyes.
• Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes. [150-180 days after surgery on the first eyes]: VA was tested monocularly under photopic (well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCNVA for the first operative eyes.
• Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5) [Up to Month 12 (Day 360-420), post first eye implantation]: The number of SSI's related to the optical properties of the IOL was calculated from the time of implantation up to Month 12. The percentage of SSIs was calculated as (# of first operative eyes with an SSI related to the optical properties of the IOL) divided by (# of first operative eyes with successful IOL implantation) times 100. The percentages were compared in the two groups to demonstrate noninferiority of FINEVISION HP IOL compared to AcrySof SN60AT IOL.
• Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). [Month 12 (Day 360-420), post-first eye implantation]: Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions without glare source in log units using the Clinical Trial Suite (M\&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
• Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). [Month 12 (Day 360-420), post-first eye implantation]: Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions with a glare source in log units using the Clinical Trial Suite (M\&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
• Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). [Month 12 (Day 360-420), post-first eye implantation]: Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions without glare source in log units using the Clinical Trial Suite (M\&S Technologies) for sine-wave gratings 1.5, 3, 6, and 12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
• Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). [Month 12 (Day 360-420), post-first eye implantation]: Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions with a glare source in log units using the Clinical Trial Suite (M\&S Technologies) for sine-wave gratings 1.5, 3, 6, and12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

Secondary outcomes

• Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes. [150-180 days after surgery on the first eye]: VA was tested monocularly under photopic(well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 66 centimeters (cm) from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCIVA for the first operative eyes.
• Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 [Month 12 (Day 360-420), post-first eye implantation]: The number and percentage of the first operative eyes with cumulative and persistent adverse events as noted in ISO 11979-7 were calculated for the two IOL groups and compared with the ISO Safety and Performance Endpoint (SPE) rates from ISO 11979-7 Table E.2. A p-value was calculated for each adverse event for each IOL group to determine the statistical significance of the difference in the percentages.
• Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) [Month 12 (Day 360-420), post-first eye implantation]: The Quality of Vision (QoV) questionnaire was used to assess subjective visual disturbances reported by subjects receiving IOLs. The QoV asked the subject to rate the frequency, severity, and degree of bothersomeness for 10 items/visual disturbances in their everyday life based on the past week. The rating scales for frequency, severity, and degree of bothersomeness were: * Frequency: 0 (Never), 1 (Occasionally), 2 (Quite Often), 3 (Very Often) * Severity: 0 (Not at all), 1 (Mild), 2 (Moderate), 3 (Severe) * Bothersome: 0 (Not at all), 1 (A little), 2 (Quite), 3 (Very) Scores for each subscale (frequency, severity, degree of bothersomeness) ranging from 0 to 100, with higher scores indicating a higher degree of visual disturbances, were computed using a Rasch scoring algorithm which utilized data from the original validation of the QoV. Hypothesis testing was not planned for this outcome measure.

Sex: All, ages: 22 Years to any

Inclusion Criteria:

1. Male or female adults, age 22 years or older at the Preoperative Visit.
2. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery.
3. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye.
4. Projected Best Corrected Distance Visual Acuity (BCDVA) of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator
5. Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye
6. Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:

   * Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit
   * Soft contact lenses for ≥ 3 days prior to the Preoperative Visit Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear.
7. Provide signed written consent prior to participation in any study-related procedures.
8. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
9. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

Exclusion Criteria:

1. History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period.
2. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome)
3. Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period.
4. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion.
5. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye
6. Rubella, congenital, traumatic or complicated cataract in either eye
7. Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
8. Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.
9. Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits.
10. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit.
11. Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
12. Pregnant or nursing females.

Participant flow

Outcome results

• Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes (Primary), Mean, logMAR: FINEVISION HP 0.018 +/- 0.0050; Control Product -0.028 +/- 0.0065 (p <0.0001)
• Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes. (Primary), Mean, logMAR: FINEVISION HP Trifocal IOL (Test Group) 0.160 +/- 0.0076; Alcon AcrySof SN60AT Monofocal IOL (Control Group) 0.551 +/- 0.0111 (p <0.0001)
• Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5) (Primary), Count of units, Eyes: FINEVISION HP Trifocal IOL (Test Group) 1; Alcon AcrySof SN60AT Monofocal IOL (Control Group) 0
• Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). (Primary), Mean, log units: FINEVISION HP Trifocal IOL (Test Group) -1.998 +/- 0.3003; Alcon AcrySof SN60AT Monofocal IOL (Control Group) -2.158 +/- 0.2742
• Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). (Primary), Mean, log units: FINEVISION HP Trifocal IOL (Test Group) -1.632 +/- 0.4171; Alcon AcrySof SN60AT Monofocal IOL (Control Group) -1.836 +/- 0.3264
• Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). (Primary), Mean, log units: FINEVISION HP Trifocal IOL (Test Group) -1.709 +/- 0.2872; Alcon AcrySof SN60AT Monofocal IOL (Control Group) -1.769 +/- 0.3251
• Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). (Primary), Mean, log units: FINEVISION HP Trifocal IOL (Test Group) -1.355 +/- 0.3495; Alcon AcrySof SN60AT Monofocal IOL (Control Group) -1.402 +/- 0.3706
• Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes. (Secondary), Mean, logMAR: FINEVISION HP 0.161 +/- 0.0063; Control Product 0.342 +/- 0.0102 (p <0.0001)
• Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 (Secondary), Count of units, Eyes: FINEVISION HP Trifocal IOL (Test Group) 1; Alcon AcrySof SN60AT Monofocal IOL (Control Group) 1 (p >0.05)
• Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) (Secondary), Mean, score on a scale: FINEVISION HP Trifocal IOL (Test Group) 39.8 +/- 18.50; Alcon AcrySof SN60AT Monofocal IOL (Control Group) 34.8 +/- 19.58

Adverse events

Time frame: Implantation through study completion, an average of 12 months

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2024-02-09)
• Statistical Analysis Plan (PDF, 2024-07-01)