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The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
Subjects were implanted with the HARMONI® Modular Intraocular Lens System (HMIOL). The eye with the higher corneal astigmatism (study eye) was assigned to Cohort 1 and received the HARMONI® Modular Intraocular Lens System with a toric optic. The fellow eye was assigned to Cohort 2 and received the HARMONI® Modular Intraocular Lens System with a non-toric optic during primary implantation, which was replaced with the appropriate optic power (toric or non-toric) during an intraoperative exchange (IOE) procedure. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, which included a Day -90 to Day -0 preoperative period.
Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange |
|
| Cohort 2 | Experimental | Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HARMONI® Modular Intraocular Lens System | Device | Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned. | Month 1 postoperative, Month 3 postoperative |
| Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned. | Month 1 postoperative, Month 3 postoperative |
| Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned. | Baseline (Day 0 preoperative), Month 3 postoperative |
| Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned. |
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Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClarVista Investigative Site | Tijuana | Estado de Baja California | 22320 | Mexico | ||
| ClarVista Investigative Site |
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This reporting group includes all implanted subjects/eyes. Note: One eye in Cohort 2 attempted implantation but was discontinued due to capsular instability (preferred term: Ciliary zonular dehiscence), which was reported as an intraoperative SAE.
This study was conducted at 1 site located in the Philippines and 1 site located in Mexico. Of the 44 subjects signing an informed consent, 12 failed to meet inclusion/exclusion criteria and 5 were withdrawn prior to implantation when the intraocular lens power was not available due to inventory restrictions.
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange |
| FG001 | Cohort 2 | Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All implanted subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | HMIOL | Implantation with HMIOL system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number, with a less negative number indicating a lesser amount of added correction. No formal statistical hypothesis testing was planned. | Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations. | Posted | Mean | Standard Deviation | diopter | Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
Adverse events were collected from time of consent until study exit: Up to 6 months, including a Day -90 to Day -0 preoperative period and a 3-month postoperative period.
An adverse event was defined as any untoward medical event that does not necessarily have a causal relationship to the study device or protocol. Conditions or diseases that were pre-existing and/or chronic but stable were not recorded as adverse events. Similarly, changes in a pre-existing and/or chronic condition or disease that were consistent with natural progression were not recorded as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye complication associated with device | General disorders | Systematic Assessment | Implantation attempted but discontinued due to capsular instability. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2016 | May 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2017 | May 1, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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|
| Intraoperative optic exchange | Procedure | Removal of one optic and replacement with another during cataract surgery for the purpose of improving refractive outcomes |
|
|
| Baseline (Day 0 preoperative), Month 3 postoperative |
| Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned. | Month 3 postoperative |
| Mean Absolute Rotation of IOL Meridian | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees, with a lower number indicating less rotation. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of < 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned. | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Number of Ocular Adverse Events Through Month 3 | Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned. | Up to Month 3 postoperative |
| Number of Device Deficiencies Post Implantation | A Device Deficiency (DD) was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned. | Up to Month 3 postoperative |
| Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2 | A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned. | Up to Month 3 postoperative |
| Percent Change in Endothelial Cell Count (ECC) at Month 3 | High quality images of the corneal endothelium (the single layer of cells on the inner surface of the cornea) were taken at the investigative site and sent to an independent central reading center for evaluation. A negative percent change value may indicate a decrease in the ability of the endothelium to maintain its primary function. No formal statistical hypothesis testing was planned. | Baseline (preoperative), Month 3 postoperative |
| Makati |
| Manila |
| 1200 |
| Philippines |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| OG001 |
| Cohort 2 |
Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric optic) |
|
|
| Primary | Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. MRCYL PE was calculated as postoperative MRCYL adjusted to 6 meters minus MRCYL target residual refractive error (TRRE), with a lower absolute value indicating a more accurate cylinder power calculation. No formal statistical hypothesis testing was planned. | Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations. | Posted | Mean | Standard Deviation | diopter | Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. No formal statistical hypothesis testing was planned. | Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations. | Posted | Mean | Standard Deviation | diopter | Baseline (Day 0 preoperative), Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Manifest refraction cylinder is the amount of power needed to correct any astigmatism that may be present. MRCYL was measured in diopters and reported as a negative number. Cylinder power reduction was calculated as the absolute preoperative magnitude of corneal cylinder (K) minus the absolute postoperative magnitude of MRCYL at the corneal plane. Therefore, the cylindrical power percent reduction was the cylinder power reduction divided by the absolute value of preoperative magnitude of corneal cylinder (K) × 100. A higher number (greater percent reduction) indicates better astigmatism correction by the toric IOL. No formal statistical hypothesis testing was planned. | Per Protocol: All eyes with successful implantation of the HMTIOL and no major protocol deviations. | Posted | Mean | Standard Deviation | percent reduction | Baseline (Day 0 preoperative), Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). MRSE PE was calculated as postoperative MRSE adjusted to 6 meters minus MRSE target residual refractive error (TRRE). The lower the absolute number, the more accurate the IOL power calculation is. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Mean | Standard Deviation | diopter | Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Absolute Rotation of IOL Meridian | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees, with a lower number indicating less rotation. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Mean | Standard Deviation | degrees | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Number | eyes | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 | IOL orientation was measured with slit-lamp photography. IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and the subsequent postoperative visit. IOL rotation was measured in degrees and is reported categorically. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Number | eyes | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. BCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Number | Percentage of eyes | Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with the correction obtained from manifest refraction testing. UCDVA is reported categorically using the Snellen fraction, which compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Number | percentage of eyes | Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Number | percentage of eyes | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Visual Acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). The Snellen fraction compares the participant's result to the result expected from a 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Implanted Eye Set: All eyes with successful implantation during surgery, with data at visit | Posted | Number | percentage of eyes | Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 | Preservation of BCDVA was defined in terms of lines lost when reading the ETDRS chart at each visit compared to the prior best-achieved BCDVA. Loss of < 1 line included subjects with less than a 1 line loss, no change or improvement in BCDVA. No formal statistical hypothesis testing was planned. | All implanted subjects/eyes | Posted | Number | eyes | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Number of Ocular Adverse Events Through Month 3 | Ocular adverse events were identified as outlined in ISO 11979-2014 Annex B. No formal statistical hypothesis testing was planned. | Safety Analysis Set: All subjects/eyes with attempted study lens implantation (successful or aborted). | Posted | Number | adverse event | Up to Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Number of Device Deficiencies Post Implantation | A Device Deficiency (DD) was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned. | All implanted subjects/eyes | Posted | Number | device deficiency | Up to Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2 | A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes. No formal statistical hypothesis testing was planned. | All implanted subjects/eyes | Posted | Number | Secondary surgical interventions | Up to Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Percent Change in Endothelial Cell Count (ECC) at Month 3 | High quality images of the corneal endothelium (the single layer of cells on the inner surface of the cornea) were taken at the investigative site and sent to an independent central reading center for evaluation. A negative percent change value may indicate a decrease in the ability of the endothelium to maintain its primary function. No formal statistical hypothesis testing was planned. | All implanted subjects/eyes | Posted | Mean | Standard Deviation | percent change | Baseline (preoperative), Month 3 postoperative | eyes | eyes |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Cohort 2 | Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic) | 0 | 27 | 1 | 27 | 0 | 27 |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
|
| Rotation from operative to Week 1 |
|
|
| Rotation from operative to Month 1 |
|
|
| Rotation from operative to Month 3 |
|
|
| eyes |
|
| Rotation from Operative >5 degrees to ≤ 10 degrees |
|
| Rotation from Operative >10 degrees to ≤ 20 degree |
|
| Rotation from Operative > 20 degrees |
|
| eyes |
|
| Rotation from Operative >5 degrees to ≤ 10 degrees |
|
| Rotation from Operative >10 degrees to ≤ 20 degree |
|
| Rotation from Operative > 20 degrees |
|
| eyes |
|
| 20/25 Snellen or Better |
|
| 20/32 Snellen or Better |
|
| 20/40 Snellen or Better |
|
| Worse than 20/40 Snellen |
|
| eyes |
|
| 20/25 Snellen or Better |
|
| 20/32 Snellen or Better |
|
| 20/40 Snellen or Better |
|
| Worse than 20/40 Snellen |
|
| eyes |
|
| 20/25 Snellen or Better |
|
| 20/32 Snellen or Better |
|
| 20/40 Snellen or Better |
|
| Worse than 20/40 Snellen |
|
| eyes |
|
| 20/25 Snellen or Better |
|
| 20/32 Snellen or Better |
|
| 20/40 Snellen or Better |
|
| Worse than 20/40 Snellen |
|
| eyes |
|
| Loss >= 1 lines |
|
| Loss >= 2 lines |
|
| Loss >= 3 lines |
|
| Loss >= 4 lines |
|
| Ciliary zonular dehiscence |
|
| Intraocular pressure increased |
|
| Iridocyclitis |
|