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The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.
This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non toric multifocal IOL combined with corneal incisional surgery | Other | Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use). Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. Corneal limbal relaxing incisions (LRI) according to the Donnenefeld nomogram will be performed combined with standard non-toric multifocal IOL. |
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| Toric multifocal IOL alone | Other | Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007. Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. The multifocal toric IOL will be implanted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toric multifocal IOL | Device | Implant of Multifocal toric intraocular lens only |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite scoring of unaided distance and near vision (monocularly) | Measurement of uncorrected and best corrected visual acuity will be done using a back-lit EDTRS chart placed at 4m. Near and distance unaided and corrected visual acuity will be measured, measuring reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk) and contrast vision under photopic and mesopic conditions (Pelli-Robson Chart). Reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk). The Salzburg Reading Desk (SRD) is the prototype of a reading chart that measures reading speed and reading distance. Contrast and light conditions are preset and reading distance (+/- 0.2 cm), reading speed and their changes during the examination are measured. This ensures an objective evaluation of measurements under the same conditions at every follow-up. | 3 months |
| Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon) | Measurement of residual astigmatism will be derived from autorefraction with an autorefractor (Topcon) with mean reading of 5 consecutive measurements in IOL mode, a subjective refraction by an optometrist using trial lenses and the cross cylinder method. All these measurements are non-invasive, non-contact and readily used in daily clinical practice. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2009 | Feb 23, 2024 |
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Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions.
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| Non-toric multifocal IOL | Device | Implant of non-toric multifocal lens plus incisional surgery |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D001251 | Astigmatism |
| D002386 | Cataract |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
| D007905 | Lens Diseases |
| D014947 | Wounds and Injuries |
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