An interventional study of FINEVISION HP IOL and Alcon AcrySof SN60AT in Eye Diseases, Postcataract Aphakia and Cataract, sponsored by Beaver-Visitec International, Inc.. Completed at 20 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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Among 36 studies in Cataract by Beaver-Visitec International, Inc. — none open to participants now, 2 under way, none of them phase 3. Cataract · Beaver-Visitec International, Inc..
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., this one has the largest enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2022, is one of 28 with no phase, and was the 17th registered.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →None of the 36 studies in Cataract by Beaver-Visitec International, Inc. is open now. The open studies under Cataract, anywhere →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 2 started in 2022.
This study's enrollment of 539 is above the median of 79 across 1,094 interventional studies indexed under Cataract.
Median enrollment 53 across the 28 interventional studies, 62 across the 8 observational. Of the 32 that completed or were terminated, 2 (6%) have results posted.
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Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.
The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 539 is above the median of 79 across 1,094 interventional studies indexed under Cataract.
Browse Cataract studies →Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
Compared within Cataract, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Eye Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag.
Device: FINEVISION HP IOL
Cataractous lens will be removed in the study eyes and the Alcon AcrySof® SN60AT IOL will be implanted in the capsular bag.
Device: Alcon AcrySof SN60AT
Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative 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.
Time frame: 150-180 days after surgery on the first eyes
Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative 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.
Time frame: 150-180 days after surgery on the first eyes
Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
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.
Time frame: Up to Month 12 (Day 360-420), post first eye implantation
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
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.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
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.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
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.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
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.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative 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 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.
Time frame: 150-180 days after surgery on the first eye
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
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.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
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.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Subjects were recruited from 20 investigative sites located in the United States.
| Milestone | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| Started | 332 | 164 |
| Completed | 315 | 159 |
| Not completed | 17 | 5 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Lost to follow-up | 10 | 2 |
| Withdrew: Withdrawal by subject | 6 | 1 |
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.
| logMAR | FINEVISION HP | Control Product |
|---|---|---|
| Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes | 0.018 ± 0.0050 | -0.028 ± 0.0065 |
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.
| logMAR | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes. | 0.160 ± 0.0076 | 0.551 ± 0.0111 |
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.
| Eyes | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5) | 1 | 0 |
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.
| log units | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| 3 cycles per degree (cpd) | -1.998 ± 0.3003 | -2.158 ± 0.2742 |
| 6 cycles per degree (cpd) | -1.853 ± 0.2996 | -2.087 ± 0.2743 |
| 12 cycles per degree (cpd) | -1.419 ± 0.3558 | -1.608 ± 0.3723 |
| 18 cycles per degree (cpd) | -0.935 ± 0.3544 | -1.149 ± 0.3822 |
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.
| log units | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| 3 cycles per degree (cpd) | -1.632 ± 0.4171 | -1.836 ± 0.3264 |
| 6 cycles per degree (cpd) | -1.569 ± 0.3381 | -1.820 ± 0.3222 |
| 12 cycles per degree (cpd) | -1.175 ± 0.3928 | -1.357 ± 0.4015 |
| 18 cycles per degree (cpd) | -0.727 ± 0.4454 | -0.956 ± 0.4332 |
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.
| log units | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| 1.5 cycles per degree (cpd) | -1.709 ± 0.2872 | -1.769 ± 0.3251 |
| 3 cycles per degree (cpd) | -1.735 ± 0.2966 | -1.868 ± 0.3196 |
| 6 cycles per degree (cpd) | -1.418 ± 0.3054 | -1.628 ± 0.3382 |
| 12 cycles per degree (cpd) | -0.778 ± 0.3572 | -0.945 ± 0.3419 |
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.
| log units | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| 1.5 cycles per degree (cpd) | -1.355 ± 0.3495 | -1.402 ± 0.3706 |
| 3 cycles per degree (cpd) | -1.453 ± 0.3331 | -1.605 ± 0.3278 |
| 6 cycles per degree (cpd) | -1.193 ± 0.4006 | -1.407 ± 0.3851 |
| 12 cycles per degree (cpd) | -0.598 ± 0.4356 | -0.822 ± 0.3641 |
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.
| logMAR | FINEVISION HP | Control Product |
|---|---|---|
| Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes. | 0.161 ± 0.0063 | 0.342 ± 0.0102 |
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.
| Eyes | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| Cumulative : Cystoid macular oedema | 1 | 1 |
| Cumulative : Hypopyon | 0 | 0 |
| Cumulative : Endophthalmitis | 0 | 0 |
| Cumulative : Lens dislocated from posterior chamber | 0 | 0 |
| Cumulative : Pupillary block | 0 | 0 |
| Cumulative : Retinal detachment | 3 | 0 |
| Cumulative : Secondary surgical intervention | 6 | 1 |
| Persistent: Corneal stroma oedema | 0 | 0 |
| Persistent: Cystoid macular oedema | 0 | 1 |
| Persistent: Iritis | 1 | 0 |
| Persistent: Raised Intraocular Pressure (IOP) requiring treatment | 0 | 0 |
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.
| score on a scale | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) |
|---|---|---|
| Frequency | 39.8 ± 18.50 | 34.8 ± 19.58 |
| Severity | 31.8 ± 16.25 | 29.3 ± 17.40 |
| Bothersomeness | 30.1 ± 21.22 | 28.8 ± 21.45 |
Collected over Implantation through study completion, an average of 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FINEVISION HP Trifocal IOL-1st Eyes | 0/332 (0%) | 8/332 (2.4%) | 17/332 (5.1%) |
| FINEVISION HP Trifocal IOL - 2nd Eyes | 0/329 (0%) | 2/329 (0.6%) | 23/329 (7%) |
| Alcon AcrySof SN60AT Monofocal IOL-1st Eyes | 0/164 (0%) | 2/164 (1.2%) | 13/164 (7.9%) |
| Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes | 0/164 (0%) | 1/164 (0.6%) | 12/164 (7.3%) |
| FINEVISION HP Trifocal IOL-Systemic | 1/332 (0.3%) | 11/332 (3.3%) | 0/332 (0%) |
| Alcon AcrySof SN60AT Monofocal IOL -Systemic | 2/164 (1.2%) | 9/164 (5.5%) | 0/164 (0%) |
| Event | FINEVISION HP Trifocal IOL-1st Eyes | FINEVISION HP Trifocal IOL - 2nd Eyes | Alcon AcrySof SN60AT Monofocal IOL-1st Eyes | Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes | FINEVISION HP Trifocal IOL-Systemic | Alcon AcrySof SN60AT Monofocal IOL -Systemic |
|---|---|---|---|---|---|---|
| Retinal detachmentEye disorders | 3/332 | 2/329 | 0/164 | 1/164 | 0/332 | 0/164 |
| VitrectomySurgical and medical procedures | 3/332 | 0/329 | 1/164 | 0/164 | 0/332 | 0/164 |
| Vitreous detachmentEye disorders | 0/332 | 0/329 | 0/164 | 1/164 | 0/332 | 0/164 |
| Macular holeEye disorders | 2/332 | 0/329 | 1/164 | 0/164 | 0/332 | 0/164 |
| AnaemiaBlood and lymphatic system disorders | 0/332 | 0/329 | 0/164 | 0/164 | 0/332 | 1/164 |
| Myocardial infarctionCardiac disorders | 0/332 | 0/329 | 0/164 | 0/164 | 0/332 | 1/164 |
| DeathGeneral disorders | 0/332 | 0/329 | 0/164 | 0/164 | 1/332 | 1/164 |
| Urinary tract infectionInfections and infestations | 0/332 | 0/329 | 0/164 | 0/164 | 0/332 | 1/164 |
| Facial bones fractureInjury, poisoning and procedural complications | 0/332 | 0/329 | 0/164 | 0/164 | 0/332 | 1/164 |
| Wrist fractureInjury, poisoning and procedural complications | 0/332 | 0/329 | 0/164 | 0/164 | 0/332 | 1/164 |
| Event | FINEVISION HP Trifocal IOL-1st Eyes | FINEVISION HP Trifocal IOL - 2nd Eyes | Alcon AcrySof SN60AT Monofocal IOL-1st Eyes | Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes | FINEVISION HP Trifocal IOL-Systemic | Alcon AcrySof SN60AT Monofocal IOL -Systemic |
|---|---|---|---|---|---|---|
| Vitreous detachmentEye disorders | 17/332 | 23/329 | 13/164 | 12/164 | 0/332 | 0/164 |
This analysis population includes all participants with successful IOL implantation with at least 1 post-operative visit (All-Implanted Analysis Set).
| Age, Categorical(Participants) | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 99 | 38 | 137 |
| >=65 years | 233 | 126 | 359 |
| Age, Continuous(years) | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) | Total |
|---|---|---|---|
| Mean | 67.1 ± 7.41 | 67.8 ± 6.78 | 67.3 ± 7.21 |
| Sex: Female, Male(Participants) | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) | Total |
|---|---|---|---|
| Female | 211 | 102 | 313 |
| Male | 121 | 62 | 183 |
| Ethnicity (NIH/OMB)(Participants) | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) | Total |
|---|---|---|---|
| Hispanic or Latino | 27 | 7 | 34 |
| Not Hispanic or Latino | 305 | 157 | 462 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 13 | 3 | 16 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 19 | 11 | 30 |
| White | 294 | 148 | 442 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2022 to primary completion in May 2024, 24 months.
Results were first posted in Jan 2025, 8 months after primary completion.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 24 months is above that.
Counting every sponsor, half of 493 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Beaver-Visitec International, Inc. →