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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-04

Study Completion Date

2011-01-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cornea Astigmatism Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Group Type OTHER

Non-toric multifocal IOL

Intervention Type DEVICE

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.

Group Type OTHER

Toric multifocal IOL

Intervention Type DEVICE

Implant of Multifocal toric intraocular lens only

Interventions

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Toric multifocal IOL

Implant of Multifocal toric intraocular lens only

Intervention Type DEVICE

Non-toric multifocal IOL

Implant of non-toric multifocal lens plus incisional surgery

Intervention Type DEVICE

Other Intervention Names

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Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007 Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use)

Eligibility Criteria

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Inclusion Criteria

* Bilateral cataract and be planning to have both eyes operated on.
* 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

* Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* Irregular corneal astigmatism on Pentacam topography
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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MAUV1005

Identifier Type: -

Identifier Source: org_study_id

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