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The main objectives of this feasibility study were:
Eligible subjects with bilateral cataracts underwent cataract extraction and IOL implantation using phacoemulsification. The study eye was implanted with the investigational device (All HMIOL Cohort). The fellow eye was treated with a commercially available intraocular lens (IOL) per standard of care procedure. At the scheduled Month 3 post-operative visit, subjects who did not opt to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 1 and followed for an additional 6 months. The total duration of participation for Cohort 1 was up to 15 months, which included a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. At the scheduled Month 3 post-operative visit, subjects who elected to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 2 and followed for an additional 12 months. The total duration of participation for Cohort 2 was up to 18 months, which included a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period.
Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc., to evaluate the safety and effectiveness of the HMIOL. 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 |
|---|---|---|---|
| All HMIOL Cohort | Experimental | HMIOL implantation with or without optic exchange |
|
| Cohort 1 | Experimental | HMIOL implantation with no optic exchange |
|
| Cohort 2 | Experimental | HMIOL implantation with optic exchange |
|
| Fellow Eye | Other | IOL implantation per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmoni Modular Intraocular Lens | 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 |
|---|---|---|
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort | Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Month 1 postoperative, Month 3 postoperative |
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative |
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. CDMA Project Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClarVista Investigational Site | Auckland | 1050 | New Zealand | |||
| ClarVista Investigational Site |
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Of the 217 enrolled, 101 subjects did exit the study prior to implantation, and 2 subjects failed implantation of Harmoni Modular Intraocular Lens (HMIOL). This reporting group includes all subjects with successful HMIOL implantation (114) by subgroup (Cohort 1 and Cohort 2).
Subjects were recruited from 3 investigational sites located in the Philippines (2) and New Zealand (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | HMIOL implantation with no optic exchange |
| FG001 | Cohort 2 | HMIOL implantation with optic exchange |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per Protocol: All subjects with successful HMIOL implantation without a major protocol deviation, by subgroup (Cohort 1 and Cohort 2)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | HMIOL implantation with no optic exchange |
| BG001 | Cohort 2 | HMIOL implantation with optic exchange |
| 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 | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort | Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
Adverse events (AEs) were collected from time of consent until study: Cohort 1: Up to 15 months, including a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. Cohort 2: Up to 18 months, including a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. "At Risk" population of systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Safety Analysis Population: All eyes with attempted study lens (HMIOL) implantation (successful or aborted after contact with the eye).
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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 (Ocular) | HMIOL implantation with no optic exchange Events reported in this group occurred in the study eye from time of consent to study exit (up to 15 months) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | Systematic Assessment |
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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 | Mar 14, 2016 | Mar 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2017 | Mar 7, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| Commercially Available Intraocular Lens | Device | IOL per investigator's standard of care |
|
| Optic exchange | Procedure | Removal of one optic and replacement with another for the purpose of improving refractive outcomes |
|
| Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange |
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Month 1 postoperative, Month 3 postoperative, Month 12 postoperative |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | 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). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | 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). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | 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). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | 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). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. | Month 1 postoperative, Month 3 postoperative, Month 12 postoperative |
| Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative |
| Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative |
| Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange |
| Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative |
| Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned. | Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange |
| Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort | VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned. | Month 3 postoperative |
| Makati City |
| Manila |
| 1200 |
| Philippines |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Month 1 postoperative, Month 3 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | 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). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | 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). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | 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). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | 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). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Month 1 postoperative, Month 3 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | eyes | eyes |
|
|
|
| Primary | Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch | eyes | eyes |
|
|
|
| Primary | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A 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. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Number | percentage of eyes | Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | eyes | eyes |
|
|
|
| Primary | Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort | VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned. | Per Protocol Population, with available data at the visit | Posted | Mean | Standard Deviation | letters | Month 3 postoperative | eyes | eyes |
|
|
|
| 0 |
| 51 |
| 2 |
| 51 |
| 2 |
| 51 |
| EG001 | Cohort 2 Pre-exchange (Ocular) | HMIOL implantation pre-optic exchange Events reported in this group occurred in the study eye from time of consent to time of optic exchange (up to 6 months) | 0 | 65 | 2 | 65 | 1 | 65 |
| EG002 | Cohort 2 Post-exchange (Ocular) | HMIOL implantation post-optic exchange Events reported in this group occurred in the study eye from time of optic exchange to time of study exit (up to 12 months) | 0 | 65 | 0 | 65 | 6 | 65 |
| EG003 | Fellow Eye (Ocular) | IOL per standard of care Events reported in this group occurred in the fellow eye from time of consent to study exit (up to 15 months if study eye was enrolled in Cohort 1, up to 18 months if study eye was enrolled in Cohort 2) | 0 | 114 | 2 | 114 | 5 | 114 |
| EG004 | Systemic (Non-ocular) | Events reported in this group occurred from time of consent to study exit (up to 15 months if subject was enrolled in Cohort 1, up to 18 months if subject was enrolled in Cohort 2) | 0 | 114 | 4 | 114 | 0 | 114 |
| Endophthalmitis | Eye disorders | Systematic Assessment |
|
| Neovascular age-related macular degeneration | Eye disorders | Systematic Assessment |
|
| Posterior Capsule Rupture | Eye disorders | Systematic Assessment |
|
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Parkinsonism | Nervous system disorders | Systematic Assessment |
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| Eye operation | Surgical and medical procedures | Systematic Assessment |
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| Intraocular lens implant | Surgical and medical procedures | Systematic Assessment |
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| Surgery | Surgical and medical procedures | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Month 3 postoperative |
|
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| Month 6 postoperative |
|
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| Month 12 postoperative |
|
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| Month 3 postoperative |
|
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| Week 1 post-optic exchange |
|
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| Month 1 post-optic exchange |
|
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| Month 3 post-optic exchange |
|
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| Month 6 post-optic exchange |
|
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| Month 12 post-optic exchange |
|
|
| Month 3 postoperative |
|
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| Month 12 postoperative |
|
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| Week 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 1 postoperative: Within ± 0.5 D of Target |
|
|
| Month 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 3 postoperative: Within ± 0.5 D of Target |
|
|
| Month 3 postoperative: Within ± 1.0 D of Target |
|
|
| Week 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 1 postoperative: Within ± 0.5 D of Target |
|
|
| Month 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 3 postoperative: Within ± 0.5 D of Target |
|
|
| Month 3 postoperative: Within ± 1.0 D of Target |
|
|
| Month 6 postoperative: Within ± 0.5 D of Target |
|
|
| Month 6 postoperative: Within ± 1.0 D of Target |
|
|
| Month 12 postoperative: Within ± 0.5 D of Target |
|
|
| Month 12 postoperative: Within ± 1.0 D of Target |
|
|
| Week 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 1 postoperative: Within ± 0.5 D of Target |
|
|
| Month 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 3 postoperative: Within ± 0.5 D of Target |
|
|
| Month 3 postoperative: Within ± 1.0 D of Target |
|
|
| Week 1 post-exchange: Within ± 0.5 D of Target |
|
|
| Week 1 post-exchange: Within ± 1.0 D of Target |
|
|
| Month 1 post-exchange: Within ± 0.5 D of Target |
|
|
| Month 1 post-exchange: Within ± 1.0 D of Target |
|
|
| Month 3 post-exchange: Within ± 0.5 D of Target |
|
|
| Month 3 post-exchange: Within ± 1.0 D of Target |
|
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| Month 6 post-exchange: Within ± 0.5 D of Target |
|
|
| Month 6 post-exchange: Within ± 1.0 D of Target |
|
|
| Month 12 post-exchange: Within ± 0.5 D of Target |
|
|
| Month 12 post-exchange: Within ± 1.0 D of Target |
|
|
| Month 1 postoperative: Within ± 1.0 D of Target |
|
|
| Month 3 postoperative: Within ± 0.5 D of Target |
|
|
| Month 3 postoperative: Within ± 1.0 D of Target |
|
|
| Month 12 postoperative: Within ± 0.5 D of Target |
|
|
| Month 12 postoperative: Within ± 1.0 D of Target |
|
|
| Title | Measurements |
|---|---|
|
| Month 1 postoperative |
|
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| Month 3 postoperative |
|
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| Month 6 postoperative |
|
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| Month 12 postoperative |
|
|
| Month 1 postoperative |
|
|
| Month 3 postoperative |
|
|
| Week 1 post-optic exchange |
|
|
| Month 1 post-optic exchange |
|
|
| Month 3 post-optic exchange |
|
|
| Month 6 post-optic exchange |
|
|
| Month 12 post-optic exchange |
|
|
| Month 1 postoperative |
|
|
| Month 3 postoperative |
|
|
| Month 12 postoperative |
|
|
| Week 1 postoperative |
|
|
| Month 1 postoperative |
|
|
| Month 3 postoperative |
|
|
| Week 1 postoperative |
|
|
| Month 1 postoperative |
|
|
| Month 3 postoperative |
|
|
| Month 6 postoperative |
|
|
| Month 12 postoperative |
|
|
| Week 1 postoperative |
|
|
| Month 1 postoperative |
|
|
| Month 3 postoperative |
|
|
| Day 1 post-optic exchange |
|
|
| Week 1 post-optic exchange |
|
|
| Month 1 post-optic exchange |
|
|
| Month 3 post-optic exchange |
|
|
| Month 6 post-optic exchange |
|
|
| Month 12 post-optic exchange |
|
|
| Week 1 postoperative |
|
|
| Month 1 postoperative |
|
|
| Month 3 postoperative |
|
|
| Month 6 postoperative |
|
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| Month 12 postoperative |
|
|
| eyes |
|
| 20/25 Snellen or Better |
|
| 20/32 Snellen or Better |
|
| 20/40 Snellen or Better |
|
| Worse than 20/40 Snellen |
|