Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery
NCT ID: NCT06277349
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2009-03-04
2011-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Non toric multifocal IOL combined with corneal incisional surgery
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.
Non-toric multifocal IOL
Implant of non-toric multifocal lens plus incisional surgery
Toric multifocal IOL alone
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.
Toric multifocal IOL
Implant of Multifocal toric intraocular lens only
Interventions
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Toric multifocal IOL
Implant of Multifocal toric intraocular lens only
Non-toric multifocal IOL
Implant of non-toric multifocal lens plus incisional surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 21 and older
* Have cataracts that allow IOL master biometry
* Regular corneal astigmatism 1.00 up to 2.50 D
* Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D
* written informed consent to surgery and participation in the study
* Speak English
Exclusion Criteria
* Irregular corneal astigmatism on Pentacam topography
21 Years
ALL
No
Sponsors
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Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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MAUV1005
Identifier Type: -
Identifier Source: org_study_id
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