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| Name | Class |
|---|---|
| targomedGmbH | INDUSTRY |
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The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral or bilateral implantation of investigational device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofocal toric IOL | Device | The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive predictability | Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D | From preoperative visit to the final postoperative visit at twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive outcomes | Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent | From preoperative visit to the final postoperative visit at twelve months |
| Refractive predictability |
| Measure | Description | Time Frame |
|---|---|---|
| Preservation of Corrected Distance Visual Acuity | Rate of eyes with postoperative CDVA 0.3 logMAR or better | 12-Months Postoperatively |
| Contrast Sensitivity | Six-Months Postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grant Sharpe | Contact | +447918937014 | grant.sharpe@zeiss.com | |
| Linda Villanueva | Contact | 7143226506 | linda.villanueva@zeiss.com |
| Name | Affiliation | Role |
|---|---|---|
| Gerd Auffarth, Dr. Med | University Hospital Heidelberg | Principal Investigator |
| Andrea Janeková, MD, Ph.D | Eye Centre Prague | Principal Investigator |
| Iveta Němcová, MD, Ph.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oční klinikaO | Prague | Prague | 18100 | Czechia |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
Percentage of eyes within ± 0.25 D, ± 0.5 D, & ± 1.0 D
| From preoperative visit to the final postoperative visit at twelve months |
| Reduction in cylindrical power | The change in manifest refractive cylinder from baseline to the final postoperative visit. | From preoperative visit to the final postoperative visit at twelve months |
| IOL Rotation | Percentage of IOLs with IOL rotation with less than 10 and 20 degrees. | From preoperative visit to the final postoperative visit at twelve months |
| Stability of IOL axis orientation | Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively | Between 30 to 60 days and 120 to 180 days |
| Axis Misalignment | The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees. | From baseline to postoperative visit 120-180 days |
| Monocular Uncorrected Distance Visual Acuity (UDVA) | 12-Month Postoperative |
| Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better | 12-Months Postoperatively |
| Monocular Best-Corrected Distance Visual Acuity (CDVA) | 12-Months Postoperatively |
| Monocular Uncorrected Intermediate Visual Acuity (UIVA) | 12-Months Postoperatively |
| Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 12-Months Postoperatively |
| Monocular (1st eye implantations) defocus curve | 12-Months Postoperatively |
| Binocular defocus curve on subjects implanted binocularly | 12-Months Postoperatively |
| Intraocular Pressure | 12-Months Postoperatively |
| Assessment of subject satisfaction, patient reported outcomes, and spectacle independence | 12-Months Postoperatively |
| IOL observations | IOL Decentration, Tilt, Discoloration, Opacity, Glistenings | 12-Months Postoperatively |
| Posterior Capsule Opacification | Rate of occurrence and grading | 12-Months Postoperatively |
| Rate of performed and planned Nd:YAG laser capsulotomies | 12-Months Postoperatively |
| Signs of intraocular inflammation |
| 12-Months Postoperatively |
| Slit lamp biomicoscopy |
| 12-Months Postoperatively |
| Fundus examination |
| 12-Months Postoperatively |
| Adverse event rate of Posterior Chamber IOL | As per ISO 11979:2024 | 12-Months Postoperatively |
| Military University Hospital, Prague |
| Principal Investigator |
| Jiří Pašta, Doc.MUDr | Premium Clinic | Principal Investigator |
| Satish Srinivasan, M.D | Ayrshire Eye Clinic | Principal Investigator |
| Pedro Tañá, M.D | Oftalmología Vistahermosa S.L | Principal Investigator |
| Oční Centrum Praha | Prague | Czechia |
|
| Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha | Prague | Czechia |
|
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
|
| Ofatlivist Alicante | Alicante | 03001 | Spain |
|
| Ayrshire Eye Clinic | Ayr | Ayrshire | KA7 2SP | United Kingdom |
|