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The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).
This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visian TICL | Other | STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visian TICL | Device | The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axis Orientation of the TICL | Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative | 18 to 24 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1) | Absolute Rotation of the TICL in treated eyes between visits (change from Operative visit to Day 1) | Day 1 (1-2 days postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Egamino, PhD | VP, Clinical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aloha Laser Vision, LLC | Honolulu | Hawaii | 96814 | United States | ||
| Price Vision Group, |
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125 subjects were enrolled and treated at 8 clinical sites in the United States. The first enrolled subject underwent surgery in the primary eye on 21 Jul 2020 and the last (fellow) eye was implanted on 09 Nov 2022.
| ID | Title | Description |
|---|---|---|
| FG000 | Visian TICL | First and second (primary and fellow) implanted eyes of enrolled subjects. The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data were collected on the whole participant level
| ID | Title | Description |
|---|---|---|
| BG000 | Visian TICL | Enrolled patients who underwent surgery with a TICL lens in at least one eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Axis Orientation of the TICL | Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative | The number of primary (first implanted) eyes with TICL rotation less than or equal to 5 degrees between 18 and 24 months postoperative. | Posted | Count of Units | Eyes | 18 to 24 months postoperative | Eyes | Eyes |
|
|
24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
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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 | All Eyes | All implanted (treated) eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Egamino | STAAR Surgical | 626-303-7902 | 2905 | jegamino@staar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2019 | Jan 22, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.
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|
Absolute rotation of the TICL in treated eyes between visits (Change from Day 1 to Week 1) |
| Week 1 (5-9 days postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1) | Absolute rotation of the TICL in treated eyes between visits (Change from Week 1 to Month 1) | Month 1 (3-5 weeks postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 1 to Month 3) | Month 3 (10-14 weeks postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 3 to Month 6) | Month 6 (21 - 26 weeks postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12) | Month 12 (11 - 14 months postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 12 to Month 18) | Month 18 (17 - 21 months postoperatively) |
| Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 18 to Month 24) | Month 24 (23 - 27 months postoperatively) |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Operative Visit |
| Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Day 1 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Week 1 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Month 1 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Month 3 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Month 6 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Month 12 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Month 18 Visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Month 24 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Operative Visit) | Operative Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Day 1 Visit) | Day 1 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Week 1 Visit) | Week 1 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 1 Visit) | Month 1 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 3 Visit) | Month 3 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 6 Visit) | Month 6 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 12 Visit) | Month 12 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 18 Visit) | Month 18 Visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 24 Visit) | Month 24 Visit |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 1 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Month 1 |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 3 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Month 3 |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 6 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Month 6 |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 12 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Month 12 |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 18 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Month 18 |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 24 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Month 24 |
| Manifest Refraction Cylinder at Month 1 | Postoperative manifest refraction cylinder at each visit | Month 1 |
| Manifest Refraction Cylinder at Month 3 | Postoperative manifest refraction cylinder at each visit | Month 3 |
| Manifest Refraction Cylinder at Month 6 | Postoperative manifest refraction cylinder at each visit | Month 6 |
| Manifest Refraction Cylinder at Month 12 | Postoperative manifest refraction cylinder at each visit | Month 12 |
| Manifest Refraction Cylinder at Month 18 | Postoperative manifest refraction cylinder at each visit | Month 18 |
| Manifest Refraction Cylinder at Month 24 | Postoperative manifest refraction cylinder at each visit | Month 24 |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Solomon Eye Physicians and Surgeons/Bowie Vision Institute | Bowie | Maryland | 20716 | United States |
| Vance Thompson Vision | Omaha | Nebraska | 68137 | United States |
| Vance Thompson Vision | West Fargo | North Dakota | 58078 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Key-Whitman Eye Center | Dallas | Texas | 75243 | United States |
| Hoopes Vision/Hoopes, Durrie, Rivera Research | Draper | Utah | 84020 | United States |
| Eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Counts |
|---|
| Participants |
|
| Eyes |
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1) | Absolute Rotation of the TICL in treated eyes between visits (change from Operative visit to Day 1) | Safety Population | Posted | Mean | Standard Deviation | degrees | Day 1 (1-2 days postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1) | Absolute rotation of the TICL in treated eyes between visits (Change from Day 1 to Week 1) | Safety Population | Posted | Mean | Standard Deviation | degrees | Week 1 (5-9 days postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1) | Absolute rotation of the TICL in treated eyes between visits (Change from Week 1 to Month 1) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 1 (3-5 weeks postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 1 to Month 3) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 3 (10-14 weeks postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 3 to Month 6) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 6 (21 - 26 weeks postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 12 (11 - 14 months postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 12 to Month 18) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 18 (17 - 21 months postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 18 to Month 24) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 24 (23 - 27 months postoperatively) | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | No | Operative Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Day 1 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Week 1 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Month 1 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Month 3 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Month 6 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Month 12 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Month 18 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit) | Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit | Safety Population | Posted | Count of Units | Eyes | Month 24 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Operative Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Operative Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Day 1 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Day 1 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Week 1 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Week 1 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 1 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 1 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 3 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 3 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 6 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 6 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 12 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 12 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 18 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 18 Visit | Eyes | Eyes |
|
|
|
| Secondary | Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit) | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 24 Visit) | Safety Population | Posted | Mean | Standard Deviation | degrees | Month 24 Visit | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Spherical Equivalent (MRSE) at Month 1 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 1 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Spherical Equivalent (MRSE) at Month 3 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 3 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Spherical Equivalent (MRSE) at Month 6 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 6 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Spherical Equivalent (MRSE) at Month 12 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 12 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Spherical Equivalent (MRSE) at Month 18 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 18 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Spherical Equivalent (MRSE) at Month 24 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 24 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Cylinder at Month 1 | Postoperative manifest refraction cylinder at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 1 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Cylinder at Month 3 | Postoperative manifest refraction cylinder at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 3 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Cylinder at Month 6 | Postoperative manifest refraction cylinder at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 6 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Cylinder at Month 12 | Postoperative manifest refraction cylinder at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 12 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Cylinder at Month 18 | Postoperative manifest refraction cylinder at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 18 | Eyes | Eyes |
|
|
|
| Secondary | Manifest Refraction Cylinder at Month 24 | Postoperative manifest refraction cylinder at each visit | Safety Population | Posted | Mean | Standard Deviation | diopter | Month 24 | Eyes | Eyes |
|
|
|
| 0 |
| 232 |
| 29 |
| 232 |
| 40 |
| 232 |
| EG001 | Non-Ocular Serious Adverse Events | Participants who experienced a non-ocular Serious Adverse Event. | 0 | 125 | 2 | 125 | 0 | 0 |
| Residual refractive error | Eye disorders | Systematic Assessment |
|
| Narrow anterior chamber angle | Eye disorders | Systematic Assessment |
|
| Pupillary block | Eye disorders | Systematic Assessment |
|
| Residual cylindrical refractive error (due to TMICL misalignment) | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Increase in cylindrical refractive error (due to TMICL rotation) | Eye disorders | Systematic Assessment |
|
| Posterior subcapsular cataract | Eye disorders | Systematic Assessment |
|
| Intraocular lens dislocation | Eye disorders | Systematic Assessment |
|
| Gastric ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| Internal carotid artery aneurysm | Vascular disorders | Systematic Assessment |
|
All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to Sponsor or designee for comment.
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| <30 degrees |
|
| ≥ 30 degrees |
|
| Missing |
|