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| Name | Class |
|---|---|
| Medevise Consulting | UNKNOWN |
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The purpose of this prospective multicenter clinical study is to evaluate the visual and refractive outcomes and safety outcomes following bilateral implantation of trifocal and/or trifocal toric 1stQ AddOn (Medicontur) intraocular lenses (IOLs) to correct residual refractive errors, astigmatism, and presbyopia in previously pseudophakic eyes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supplementary intraocular lenses | Device | Implantation of supplementary intraocular lenses into the ciliary sulcus in previously pseudophakic eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Corrected Near Visual Acuity (DCNVA) | Monocular and binocular DCNVA changes at 6 months after IOLs implantation in comparison to Baseline. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Corrected Near Visual Acuity (DCNVA) | Monocular and binocular DCNVA changes after IOLs implantation in comparison to Baseline. | 12 months |
| Uncorrected Near Visual Acuity (UNVA) | Monocular and binocular UNVA after IOLs implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Pseudophakic subjects after uncomplicated implantation of a monofocal intraocular lens (IOL) in the capsular bag who have elected to undergo a secondary add-on IOL procedure to correct presbyopia and/or the residual refractive and/or cylindric error after primary lens implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emese Dohovits | Contact | +36705292091 | edohovits@medicontur.hu |
| Name | Affiliation | Role |
|---|---|---|
| Prof Sathish Srinivasan | Ayrshire Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipolis Antwerp Private Clinic | Recruiting | Antwerp | 2610 | Belgium |
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| 12 months |
| Uncorrected Intermediate Visual Acuity (UIVA) | Monocular and binocular UIVA after IOLs implantation | 12 months |
| Distance Corrected Intermediate Visual Acuity (DCIVA) | Monocular and binocular DCIVA after IOLs implantation | 12 months |
| Uncorrected Distance Visual Acuity (UDVA) | Monocular and binocular UDVA after IOLs implantation | 12 months |
| Corrected Distance Visual Acuity (CDVA) | Monocular and binocular CDVA after IOLs implantation | 12 months |
| Institut Ophtalmologique de l'Ouest Jules Verne | Recruiting | Nantes | 44300 | France |
|
| Hospital Vithas Almería | Recruiting | Almería | 04120 | Spain |
|
| Ayrshire Eye Clinic | Recruiting | Ayr | Scotland | KA7 2SP | United Kingdom |
|
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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