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The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.
All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12.
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 |
|---|---|---|---|
| Primary Implantation (Cohort 1) | Experimental | Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
|
| Optic Exchange (Cohort 2) | Experimental | Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange |
|
| 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 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). 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation |
| 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). 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL. | Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange |
| 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 subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. 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 |
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Of the 150 subjects enrolled, 72 were exited from the study prior to attempted implantation with the HARMONI™ Modular Intraocular Lens (HMIOL) System. This reporting group includes all subjects / eyes with attempted implantation.
A total of 5 Investigators participated in the study; 3 in the Philippines, 1 in Mexico, and 1 in Panama.
| ID | Title | Description |
|---|---|---|
| FG000 | All HMIOL Cohort | Implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population: All subjects/eyes with attempted HMIOL implantation (successful or aborted after contact with the eye)
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| ID | Title | Description |
|---|---|---|
| BG000 | All HMIOL Cohort | All subjects with attempted implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes |
| 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 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). 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data. | Posted | Number | percentage of eyes | Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation | eyes | eyes |
|
Adverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes.
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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 | Non-Ocular | All subjects with attempted HMIOL implantation (successful or aborted after contact with the eye) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iridocyclitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon, 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2018 | Nov 2, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 7, 2016 | Nov 2, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| Optic Exchange | Procedure | Removal of one optic and replacement with another for the purpose of improving refractive outcomes |
|
| Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation |
| 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 subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange |
| Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned. | Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation |
| Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned. | Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange |
| Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Day 0 primary implantation |
| Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Day 0 primary implantation |
| Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Day 0 post-exchange |
| Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Day 0 post-exchange |
| Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Day 0 post-exchange |
| Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange) | 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, as determined by the investigator. No formal statistical hypothesis testing was planned. | Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. |
| Number of Device Deficiencies | A device deficiency 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. | Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cohort 1 - Day 1 Post Primary Implantation |
Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
| OG001 | Cohort 1 - Week 1 Post Primary Implantation | Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
| OG002 | Cohort 1 - Month 1 Post Primary Implantation | Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
| OG003 | Cohort 1 - Month 3 Post Primary Implantation | Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
| OG004 | Cohort 1 - Month 6 Post Primary Implantation | Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
| OG005 | Cohort 1 - Month 12 Post Primary Implantation | Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12. |
|
|
| 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). 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL. | Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data. | Posted | Number | percentage of eyes | Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange | 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 subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data. | Posted | Number | percentage of eyes | Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation | 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 subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. | Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data. | Posted | Number | percentage of eyes | Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange | eyes | eyes |
|
|
|
| Primary | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned. | Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data. | Posted | Mean | Standard Deviation | diopter | Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation | eyes | eyes |
|
|
|
| Primary | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned. | Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data. | Posted | Mean | Standard Deviation | diopter | Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange | eyes | eyes |
|
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| Primary | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | surgeon response | Day 0 primary implantation | eyes | eyes |
|
|
|
| Primary | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | surgeon response | Day 0 primary implantation | eyes | eyes |
|
|
|
| Primary | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | surgeon response | Day 0 post-exchange | eyes | eyes |
|
|
|
| Primary | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | surgeon response | Day 0 post-exchange | eyes | eyes |
|
|
|
| Primary | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | surgeon response | Day 0 post-exchange | eyes | eyes |
|
|
|
| Primary | Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange) | 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, as determined by the investigator. No formal statistical hypothesis testing was planned. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | SSI | Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. | eyes | eyes |
|
|
|
| Primary | Number of Device Deficiencies | A device deficiency 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. | Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data | Posted | Number | device deficiencies | Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. | eyes | eyes |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Ocular | All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) | 0 | 100 | 0 | 100 | 12 | 100 |
| Intraocular pressure increased | Investigations | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| eyes |
|
| 20/25 Snellen or Better |
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| 20/32 Snellen or Better |
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| 20/40 Snellen or Better |
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| Worse than 20/40 Snellen |
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| eyes |
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| 20/25 Snellen or Better |
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| 20/32 Snellen or Better |
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| 20/40 Snellen or Better |
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| Worse than 20/40 Snellen |
|
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| 20/32 Snellen or Better |
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| 20/40 Snellen or Better |
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| Worse than 20/40 Snellen |
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| eyes |
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| Title | Measurements |
|---|---|
|
| Slightly more difficult than a trd'l single pc IOL |
|
| More difficult than a traditional single piece IOL |
|
| Title | Measurements |
|---|
|
| Difficult |
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| Very difficult |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|