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The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)
The study is a prospective series study with he principal objective to determine the IOL constant.
The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted with Ankoris IOL | To assess the IOL stability, slitlamp photos of the consecutive 30 patients with respect to time will then be analysed with a 5% confidence interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankoris | Device | Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The principal objective of the study is to determine the IOL constant. | IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL. | 1-2 hours |
| The principal objective of the study is to determine the IOL constant. | IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL. | 1 month |
| The principal objective of the study is to determine the IOL constant. | IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rotational stability | To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction. | 1-2 hours |
| Rotational stability | To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction. |
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Inclusion Criteria:
Exclusion Criteria:
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Pseudophakic patients implanted with one of the two IOLs
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| Name | Affiliation | Role |
|---|---|---|
| Guy Sallet, MD | Private Eye Institue Aalst, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy Sallet | Aalst | Belgium |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 1 month |
| Rotational stability | To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction. | 3 months |