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| Name | Class |
|---|---|
| Carl Zeiss Meditec AG | INDUSTRY |
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Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.
All patients participating in the study will have the intraocular lens (IOL) AT TORBI 709 implanted from Carl Zeiss Meditec AG, Jena, Germany, with CE marking. All patients will be treated according to standard clinical practice. A preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the IOLMaster 700 Carl Zeiss Meditec AG, Jena, Germany, CE marked optical non-contact biometer, contrast sensitivity with the CC-100 screen (Topcon Europe, The Netherlands), and the Catquest-9SF (European Registry of Quality Outcomes for Cataract and Refractive Surgery, founded by the European Society of Cataract and Refractive Surgeons). The sponsor has received an unrestricted research grant by Zeiss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | All participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant of the AT-TORBI 709 lens | Device | Implant of the AT-TORBI 709 lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the refractive error | Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) ) | 12 months |
| Measurement of the rotational stability | Measurement of the rotational stability | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of visual acuity | Measurement of visual acuity | 12 months |
| Measure of corneal topography | Measure of corneal topography | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are going to undergo conventional cataract surgery by phacoemulsification following regular clinical practice and present hyperopia with astigmatism.
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Tañá Rivero, Doctor | OFTALVIST (Oftalmología Vistahermosa S.L) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OFTALVIST (Oftalmología Vistahermosa S.L.) | Alicante | 03015 | Spain | |||
| OFTALVIST (Oftalmología Vistahermosa S.L.) |
A publication summarizing the results of the study will be made public after the study termination.
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D006956 | Hyperopia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| Measure of ocular biometry | Measure of ocular biometry | 12 months |
| Measure of contrast sensitivity | Measure of contrast sensitivity | 12 months |
| Satisfaction questionaire | For several questions percentage of respondants answering each of five possible provided answers ranging progressively from strong disatisfaction to strong satisfaction (1-4) as well as an answer for those patients who cannot decide (5) | 12 months |
| Slit lamp examination | Slit lamp examination | 12 months |
| Valencia |
| 46004 |
| Spain |